Abstract:
Disclosed is a drug for killing acid-fast (red)  bacillus  and use thereof. The drug, using fuchsin as active ingredient, can effectively kill acid-fast  bacillus  and remove  mycobacterium tuberculosis  and leprosy  bacillus  in human body.

Description:
CROSS REFERENCE OF RELATED APPLICATION 
     This is a national phase national application of an international patent application number PCT/CN2013/001393 with a filing date of Nov. 15, 2013, which claimed priority of two foreign applications which are filed in China: application number 201310011373.4 with a filing date of Jan. 11, 2013 and application number 201310177413.2 with a filing date of May 14, 2013. The contents of these specifications, including any intervening amendments thereto, are incorporated herein by reference. 
     BACKGROUND OF THE PRESENT INVENTION 
     Field of Invention 
     The present invention relates to medical technology, and more particularly related to using the raw materials for chemical testing or chemical engineering—basic fuchsine, as the key active ingredient and processing with traditional Chinese medicine and food article to manufacture a drug to cure tuberculosis and leprosy—a drug to kill acid-fast bacilli (red stain). 
     Description of Related Arts 
     Tuberculosis is a disease caused by  Mycobacterium tuberculosis. Mycobacterium tuberculosis  is a pathogen which causes infection inside the cell.  Mycobacterium tuberculosis  can adapt to acidic environment, is resistance against phagosomes of macrophages for a long period of time and can escape against the acidification of environment such that  Mycobacterium tuberculosis  can survive inside the body for an extended long period of time. Therefore, tuberculosis is a persistent and chronic infectious disease.  Mycobacterium tuberculosis  enters into the body from the respiratory tract, and through the blood stream, it spreads and bleeds in different organs, or even into the bone or lymph nodes. At present, the most common disease being caused is pulmonary tuberculosis, which is airborne and can be widely spread and impose great health hazards. Tuberculosis can be latent, carriers may have no obvious symptoms and therefore is hard to prevent. It is a big challenge and a long lasting health hazard to human. 
     Because of the emergence of resistant strains and the application of immunosuppression agents, the tuberculosis outbreak has worsen suddenly at worldwide level. According to WHO statistics, about one third of the world&#39;s population is infected by  M. tuberculosis , and in some developing countries, the TB carriers in adults can reach 80% of which 5-8% TB carriers can develop into active TB disease. 
     At present, about eight million new cases of TB occur every year at worldwide level and causes the death of about three million people. In China, two hundred and fifty thousand people are died of TB every year, which is twice as the total number of death caused by transmissible diseases of all kinds. According, TB is a real worldwide health hazards to human. 
       M. tuberculosis  enters into human body through the respiratory tract, survives and replicates inside the alveolar macrophages, then further spreads to proximal unactivated alveoli to form a Ghon focus. During the cell mediated immune response,  M. Tuberculosis  grows inside the macrophages and tubercles are formed of which the center of the tubercle is characterized by “caseation necrosis”, that the tubercles are capable of restricting the multiplication of  M Tuberculosis . For the majority of carriers of  M. tuberculosis , the  M. tuberculosis  and its host are in a state of mutually coexistence, that the  M. tuberculosis  is surrounded by fiber inside the cheesy necrotic lesion and cannot undergo multiplication. However, when the human immune system is damaged and the human body is weakened, the restricted  M. tuberculosis  will be re-activated and replicate, a large number of  M. tuberculosis  will be released from the liquefied tubercles and spread throughout the human body. These patients with primary or secondary infection require drug treatment. The conventional first line drugs includes: 1. isoniazid, 2. rifampin, 3. streptomycin 4. pyrazinamide 5. ethambutol. 
     All these drugs have serious toxic side effect (For example, isoniazid and rifampin can easily cause elevated serum alanine aminotransferase, hepatomegaly, jaundice, nausea, vomiting, streptomycin can cause auditory nerve damage, ethambutol can caused optic nerve damage). In additional, during the treatment process, these drugs do not kill the bacteria and allow the bacteria to remain inside the body while only inhibiting its growth. The therapeutic effect is a negative result for sputum  Mycobacterium tuberculosis  (cannot detect acid-fast bacilli), that the bacteria is surrounded and hidden inside the human body. Once the body immune system is weak or is infected by an influenza, the bacteria will be activated and grow again, which is a painful process. The only treatment, again, is the drug treatment. Since the drug treatment may cause toxic side effect to the patients and causes damage to liver, kidney, nervous system, gastrointestinal and hematopoietic organ, the side effect may include extremely abnormal level of aspartate aminotransferase, alanine aminotransferase, urea, creatinine, urea nitrogen and etc. In some cases, hematuria may occur and the practitioner has to switch to liver and kidney treatment from TB treatment. Many TB patients cannot recover from TB but a great damage to liver and kidney is caused. 
     Leprosy: 
       Mycobacterium leprae  is the pathogen which causes leprosy. The difference between this bacteria and other mycobacteria is that this bacteria cannot be cultured in artificial culture base. Therefore, the diagnosis of leprosy can only be relied on smear examination of acid-fast stain. 
     The common characteristics of  mycobacterium leprae  and  mycobacterium tuberculosis  are difficult to stain and resistance to decolorization by acid and alcohol after accepting a stain, therefore they are also referred to as acid-fast bacilli. Both of them do not have flagella, spore and capsule, and are Gram (G) positive bacilli (Red stain after acid-fast staining (+)). 
     In taxonomy, both  Mycobacterium leprae  and  Mycobacterium tuberculosis  are classified under the class Actinobacteria, the order Actinomycetales and the branch  Mycobacterium . The differences between  Mycobacterium leprae  and  Mycobacterium tuberculosis  are summarized in Table 1: 
     
       
         
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                   
                   
                   
                   
                   
                   
                 Gram 
                 Acid- 
               
               
                   
                 Infection 
                 Growth 
                 Infection 
                 In vitro 
                   
                 stain 
                 Fast 
               
               
                 Name 
                 Method 
                 Temp. 
                 site 
                 cultivation 
                 Transmission 
                 (G + ) 
                 Stain 
               
               
                   
               
             
             
               
                 
                   Mycobacterium 
                 
                 Inside 
                 37° C. 
                 Internal 
                 Successful 
                 Air 
                 Positive 
                 Positive 
               
               
                 
                   tuberculosis 
                 
                 phagocyte 
                   
                 organs 
                   
                   
                   
                 (Red) 
               
               
                 
                   Mycobacterium 
                 
                 Inside 
                 28° C. 
                 Body 
                 Un- 
                 Air 
                 Positive 
                 Positive 
               
               
                 
                   leprae 
                 
                 phagocyte 
                   
                 Surface 
                 successful 
                 Contacts 
                   
                 (Red) 
               
               
                   
                   
                   
                 (Skin) 
               
               
                   
               
             
          
         
       
     
     At present, the drugs for  Mycobacterium leprae  are basically the same as the drugs for  Mycobacterium tuberculosis  except that the dosage for  Mycobacterium leprae  is much higher and the treatment course is longer. The commonly used drugs includes rifampin, chlorophenol diazoxide, sulfamide and etc., which are highly toxic drugs and may cause serious damage to liver, kidney, nervous system, gastrointestinal and hematopoietic organ. 
     Basic Fuchsine (also known as: new fuchsine, fuchsine salt, rosaniline hydrochloride): 
     1. Basic use of basic fuchsine 
     Basic fuchsine is the strongest nuclear stain which can stain particles of viscoelastic tissue and fuchsinophilic substances, and is a nuclear stain for central nervous system. In bacteriology, it is used to identify  Mycobacterium tuberculosis . In analytical chemistry, it is used to prepare Schiff&#39;s reagent for aldehydes testing. In bromate titration, it is used as an redox indicator. It is also used for dyeing cotton, linen, artificial fibers, leather, feathers, fat and etc. as well as for manufacture of color precipitates. 
     2. Sources of Preparation 
     In the presence of iron and zinc chloride, react hydrochlorides of aniline, o-toluidine and p-toluidine with nitrobenzene for condensation, then separate by acid-base extraction and obtain by crystallization. 
     3. Chemical structure 
     
       
                 
         
             
             
         
      
     
     Description of Structure: 
     For use as a stain for bacteria, the majority of synthetic substances are organic compounds containing a benzene ring (Basic fuchsine is one of the kind) in which a chromophore group and an auxochrome group are provided on the benzene ring. The chromophore group includes a nitro group (—NO2) and an azo group (—N═N—), while the auxochrome group includes a hydroxyl (—OH) and an amino group (—NH2). The chromophore group is responsible for the color of a compound and a benzene-containing compound with a chromophore group is called a chromogen. This type of compounds is not a dye because it does not have any affinity to the dying object and is easily separated from the dying object. Therefore, the auxochrome group is required. The auxochrome group does not contribute any color to the dyeing object but has the ability of dissociation to provide ionic character to a compound. After dissociation, the dye materials can bind to the dyeing object and provide color to the dyeing object. 
     The auxochrome group may be a basic group (such as a —NH2 group) or an acid group (such as a —OH group). The more the —NH2 group or the —OH group, the stronger is the basicity or acidity. If the number of each group is one, then the basic group will dominate. Accordingly, the pH of the dye can be determined by the nature of the auxochrome group. The basic fuchsine has no —OH group in its structure, and therefore is a basic dye. 
     Because organic dye is an organic acid or base with color which is difficult to dissolve in water and is soluble in organic solvent, usually they are made into salt in order to make them easier to dissolve in water. Therefore, basic fuchsine is also called fuchsine salt. In conclusion, the only difference between the above two formulae is just one auxochrome group (CH 2 ), which is a substance existed in the form of two structures in solution. 
     Principle of Acid-Fast Bacilli Stain 
     Acid-fast bacilli contains mycolic acid. Basic Fuchsine (C 20 H 20 N 3 Cl or C 19 H 18 N 3 Cl) has a higher solubility in lipids than in hydrochloric acid and alcohol. Therefore, both can be combined strongly and is not easily decolorized by hydrochloric acid or alcohol. In addition, maintaining the integrity of the surface cell structure during the dyeing process is an important factor for maintaining its acid resistance. It is because a complete cell wall can prevent the overflow of lipids which is stained by basic fuchsine. Therefore, the red stain of the acid-fast bacilli can be maintained even after bleaching. Non acid-fast bacilli does not contain mycolic acid, cannot resist decoloring by hydrochloric acid or alcohol and therefore can be re-stained by methylene blue into blue color. 
     At present, the mechanism of bacteria stain is not completely clear. According to the available evidence, the dyeing process is neither purely physical nor purely chemical, but rather a combination of both. 
     According to the characteristics of acid-fast bacilli, acid-fast staining is mainly used in testing of  Mycobacterium tuberculosis  and  Mycobacterium leprae.    
     4. Molecular formula and molecular weight
 
C 20 H 20 N 3 CL=337.84  Formula I:
 
C 19 H 18 N 3 CL=323.82  Formula II:
 
     5. Properties: green metallic luster crystal, soluble in ethanol and amyl alcohol, slightly soluble in water, red in color in aqueous solution, insoluble in ether. 
     SUMMARY OF THE PRESENT INVENTION 
     An object of the present invention is to provide a drug for killing acid-fast (Red stain)  bacillus , that the drug can effectively killing acid-fast (Red stain)  bacillus , completely eliminate the  Mycobacterium tuberculosis  and  Mycobacterium Leprae  inside human body and therefore is a cure for tuberculosis and leprosy. 
     In particular, the present invention provides a drug for killing acid-fast (Red stain)  bacillus , characterized in that, the drug comprises basic fuchsine as the active ingredient. 
     According to the drug for killing acid-fast (Red stain)  bacillus  of the present invention, characterized in that, the drug comprises an excipient or an auxiliary ingredient which is pharmaceutically acceptable to the active ingredient basic fuchsine. Preferably, the excipient or the auxiliary ingredient is selected from ground rice, wheat germ or cereal. In particular, ground rice is mostly preferred. When ground rice is selected as the excipient, the drug composition by percentage weight is preferably: basic fuchsine 55-66%, ground rice 35-45%. 
     Nutrient content of ground rice: rich in fiber, great quantity of VB, VE vitamins and minerals such as calcium, phosphorus, iron and etc., commonly known as intestinal scavenger, improve gastrointestinal function, increase intestinal peristalsis, remove intestinal toxicity, timely discharge the intestinal garbage outside the body, provide relieve to constipation, promote absorption of nutrients, promote blood circulation, improve immunity, enhance physical fitness. Also, the dietary fiber which is rich in ground rice can combine to the cholesterol in the bile and promote the discharge of cholesterol, and provide cleansing effect to the blood and lipid regulation effect. 
     Wheat germ: concentrated source of several essential nutrients for life, including fat, protein, a variety of enzymes, vitamins, minerals and etc. The content of vitamin B1 is 3.5 times of our daily needs. Also contain a lot of vitamin E and linoleic fatty acid, and vitamin B6, which is not commonly found in other food. 
     According to the drug for killing acid-fast (Red stain)  bacillus  of the present invention, characterized in that, the drug is prepared into oral preparation, injectable preparation or external use preparation. 
     According to the drug for killing acid-fast (Red stain)  bacillus  of the present invention, characterized in that, the drug is prepared into tablets, oral solution, capsules, injection solution, ointments, tinctures, powders, granules, suppositories, creams, transdermal preparations or dietary supplements. 
     According to the present invention, the use of basic fuchsine for preparation of drug to inhibit or kill acid-fast (Red stain)  bacillus  and for the preparation of drug to treat tuberculosis and/or leprosy are provided. 
     The increase in pH in vivo is beneficial to removal of  Mycobacterium tuberculosis  and  Mycobacterium Leprae:    
     The optimum pH of human body is between 7.35-7.45. This body condition has strongest immunity and highest enzymes activity level. The body fluids are weakly alkaline and is good for metabolism. 
     When the human body is infected by  M. Tuberculosis , the pH of human body is decreased and the body becomes an acidic body (also called rancid body) because the bacteria&#39;s pH is between about 2-5 and hence the immunity is lowered. Since the pH value can directly affect the enzymatic activity of human body and hinder the immune response, while the composition of TB is complicated and its toxicity is related to the lipid content in the bacteria. For example, sulfolipids can inhibit the integration of lysosomes inside macrophage with phagosome. Accordingly, it is impossible to remove the bacteria from the human body. 
     When a patient object takes basic fuchsine, the pH of his body fluid (the urine being discharged) has a significantly increased trend. Therefore, the infected body, which is weakly acidic, is recovered to become weakly basic and this is beneficial to increasing the body&#39;s immunity such that  Mycobacterium tuberculosis  can be inhibited or removed. Because the integration of lysosomes inside macrophage with phagosome cannot be prevented, the bacteria can be removed. The changes in urine pH after taking basic fuchsine is illustrated in Table 2 and  FIG. 1 : 
     
       
         
               
             
               
               
               
             
               
               
               
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 2 
               
             
             
               
                   
               
               
                 Change of urine pH with time of Patient object (vegetarian) 
               
             
          
           
               
                 Time 
                 Patent&#39;s urine pH value 
                 Av- 
               
             
          
           
               
                 (h) 
                 Li 
                 Hu 
                 Hou 
                 Zhang 
                 Qi 
                 Hu 
                 Yan 
                 Wu 
                 Cao 
                 erage 
               
               
                   
               
             
          
           
               
                 Before 
                 5.5 
                 6 
                 6.5 
                 6 
                 5.5 
                 6 
                 6.5 
                 6 
                 6 
                 6 
               
               
                 drug 
               
               
                 After 
                 6 
                 6.5 
                 7 
                 6.5 
                 6 
                 6.5 
                 7 
                 6.5 
                 6.5 
                 6.5 
               
               
                 drug 
               
               
                 1 h 
               
               
                 After 
                 6.5 
                 7 
                 7.5 
                 7 
                 6.5 
                 7 
                 7.5 
                 7 
                 7 
                 7 
               
               
                 drug 
               
               
                 2 h 
               
               
                 After 
                 6 
                 6.5 
                 7 
                 6.5 
                 6 
                 6.5 
                 7 
                 6.5 
                 6.5 
                 6.5 
               
               
                 drug 
               
               
                 3 h 
               
               
                 After 
                 6 
                 6.5 
                 7 
                 6.5 
                 6 
                 6.5 
                 7 
                 6.5 
                 6.5 
                 6.5 
               
               
                 drug 
               
               
                 4 h 
               
               
                 After 
                 5.5 
                 6 
                 6.5 
                 6 
                 5.5 
                 6 
                 6.5 
                 6 
                 6 
                 6 
               
               
                 drug 
               
               
                 5 h 
               
               
                 After 
                 5.5 
                 6 
                 6.5 
                 6 
                 5.5 
                 6 
                 6.5 
                 6 
                 6 
                 6 
               
               
                 drug 
               
               
                 6 h 
               
               
                   
               
             
          
         
       
     
     Remarks: The urine pH value reached the peak value at 2-3 hours after taking drug, and the peak period can sustain for 3-4 hours, then return to normal at 5-6 hours after taking drug. 
     According to our studies, basic fuchsine can be used in preparation of drug for tuberculosis and leprosy. At present, we discovered that the use of basic fuchsine to treat tuberculosis is better than the existing treatment. The advantages are illustrated as follows: 
     (1) Not toxic: no liver or kidney damages is observed in patients taking drug for more than two years 
     (2) Easily available and advantageous in promotion 
     (3) Low cost, relieve financial burden to individual or nation 
     (4) Thorough treatment: for patients who are recovered, no single occurrence of recurrence and all TB symptoms are disappeared. 
     (5) No adverse reactions: during the course of treatment, no side effect is observed in all cases 
     (6) Treatment convenience: oral application is sufficient, no hospitalization is required. 
     (7) The drug will not remain inside the body while the body fluid can improve transiently. The change of urine pH after drug is illustrated in Table 2. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is the curve showing the changes of urine pH of patients with time after taking drug. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     In this embodiment, the basic fuchsine is purchased from Tianjin Ju Hua Chemical Company Limited. 
     Embodiment 1 
     Toxicity Test of Basic Fuchsine 
     Materials: 24 white guinea pigs, purchased from Shenyang Pharmaceutical University, regular feeding; Basic fuchsine, from Tianjin Ju Hua Chemical Company Limited. 
     Matching and grouping of experimental animals: randomly divided into 4 groups (each group includes 6 counts, equal number of male and female), namely, control, high, medium, low fuchsine dosage group. 
     Method of administration: For each guinea pig, administered one time per day at a fixed time in the morning, the dosage for high, medium, low fuchsine dosage group are 8 mg/kg body weight/d, 6 mg/kg body weight/d, and 4 mg/kg body weight/d respectively; the drug administration period is 21 days, observe 3˜4 times per day, observe the guinea pig by spirit condition, appetite, gloss level of skin and hairs, physical condition, alertness and ability to escape. No changes is observed after 21 days. 
     Embodiment 2 
     According to the principle of in vitro staining to  M. tuberculosis  and  M. leprae  (see acid-fast bacilli staining principle), it is learned that basic fuchsine has a special affinity to  M. tuberculosis  and  M. leprae  and is easily stained. 
     After taking basic fuchsine, the basic fuchsine activity over time can be observed through the blood phenomenon at different times. The fuchsine is absorbed into the bloodstream in a dissolved state, then through the process of blood cells, coloring or combination opportunity is provided to the  M. tuberculosis  and  M. leprae  inside the phagocytes, while the pH of body fluid is increased and the growing environment of the bacteria is destroyed, the bacteria is stained and the immune recognition ability is increased, then the activity of immune system is promoted to fully utilized. Accordingly, the basicity and the staining effect on bacteria of fuchsine are the key to remove or kill the bacteria. 
     Blood Observation 
     I. Observation object 
     1. Healthy individual as normal subject for observation 
     2. Patient recovered from the disease who volunteer to testing subject as volunteer subject 
     II. Instrument: 
     Binocular microscope xsp-12G model 
     Manufacturer: Jiang Optical Instrument Main Factory 
     III. Reagents 
     Wright-Giemsa stain solution (available in the market) 
     Phosphate buffer (available in the market) 
     IV. Method of Operation 
     1. Obtain peripheral blood smear from normal subject and volunteer subject (normal control blood film, standby use) 
     2. Obtain peripheral blood smear from volunteer subject at different time after taking fuchsine (oral fuchsine blood film, standby use) 
     3. After the last blood sampling is complete, carrying staining together with the blood film before taking fuchsine orally of volunteer subject and the peripheral blood film of normal subject 
     V. observe oral fuchsine blood film under microscope with 100× objective lens (oil immersion) and 12.5× eyepiece, real object is viewed under magnification at 1250 times and the results are shown in Table 3. 
     
       
         
               
             
               
               
             
               
               
             
           
               
                 TABLE 3 
               
             
             
               
                   
               
               
                 Results of observation 
               
             
          
           
               
                 Drug taking 
                   
               
               
                 time (h) 
                 The status of Stain absorption by blood 
               
               
                   
               
             
          
           
               
                 0.5 
                 Stain is cluster outside the cell in dissolved form, 
               
               
                   
                 occasionally inside the cell, uneven distribution 
               
               
                 1 
                 Stain existed inside and outside the cell in dissolved 
               
               
                   
                 form, such as in thick cloudy state, occurrence is 
               
               
                   
                 more inside the cell than outside the cell 
               
               
                 2 
                 Uniform stain overflowed from the cell to outside is 
               
               
                   
                 commonly seen, such as cloud mist state 
               
               
                 4 
                 Traces of stain is seen occasionally from the inside 
               
               
                   
                 edge of cell 
               
               
                 6 
                 Just like the control normal blood film, no stain is 
               
               
                   
                 observed 
               
               
                   
               
             
          
         
       
     
     Results of Observation: 
     1. After taking fuchsine, the fuchsine is absorbed through the body into the blood, then entered into the cell through the cell membrane, then remained inside the cell for about 2-4 hours. 
     2. The  Mycobacterium tuberculosis  and the  Mycobacterium Leprae  inside the phagocytes have the opportunities to combine to fuchsine, which is then stained or eliminated. 
     Embodiment 3 
     Drug Susceptibility Testing 
     (I) Drug: Basic Fuchsine 
     (II) Culture Method: Lowenstein-Jensen medium (Improved method) 
     (III) Composition of Lowenstein-Jensen medium: 
     KH2PO4: 2.4 g; MgSO4.7H2O 0.24 g; magnesium citrate: 0.6 g; asparagine: 3.6 g; glycerin: 12 ml; distilled water: 600 ml; potato starch: 30 g; fresh whole egg liquid: 1000 ml; 2% malachite green solution: 20 ml 
     (IV) Instrument 
     1. Digital Biochemical Incubator (Huangshi City Hengfeng Medical Devices Company Limited): 36° C. (special setting) 
     2. Biological safety cabinet: Biobase Bioteoh 
     Model specifications: BSC-1500IZB2-X 
     Manufacturer: Jinan Xinjiuxi Biotechnology Company Limited 
     3. Steam Incubator: 85° C. 
     Manufacturer: Beijing Xinzhongdaye Daibiao Company Limited 
     4. Drug: 2% basic fuchsine aqueous solution: 100 ml 
     (V) Preparation of culture medium 
     Add water to KH2PO4, MgSO4.7H2O, magnesium citrate, asparagine and glycerin, dissolve through heating in a boiling water bath, then add potato starch and continue heating in water bath for 30 minutes, stir continuously to form a uniform paste. After cooling to about 60° C., add 1000 ml fresh whole egg liquid and 20 ml 2% malachite green solution, mix thoroughly and then filter by double-layered gauze, then dispensed into test tube with screw cap. 7 ml of the prepared solution is added to each test tube, then add the 2% basic fuchsine solution according to a specific proportion into the test tube (see Table 3 for the adding amount), then place the test tube into the 85% steam incubator for 90 minutes, cooling to 60° C. or below and then place the test tube inclinedly into the biological safety cabinet (also called purification station), thereby the culture medium is cooled to solidify and form an incline surface. Put 10 −2 /ml living bacilli solution of  Mycobacterium tuberculosis  to the incline surface of the culture medium. The living bacilli solution for each tube is 0.1 ml. The concentration of bacilli solution in the culture medium is 10 −3  mg/ml. Place in Digital Biochemical Incubator to culture. After culture for 5 weeks, no bacteria growth refers to drug susceptibility, continue bacteria growth refers to drug non-susceptibility (See Table 4 for testing results). 
     
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 4 
               
             
             
               
                   
               
               
                 Testing results 
               
             
          
           
               
                   
                 Adding amount of 
                 Drug final 
                   
                   
               
               
                 Tube 
                 2% basic fuchsine 
                 dilution 
                 Time in 36 C. 
                 Testing 
               
               
                 number 
                 solution 
                 factor 
                 incubator 
                 results 
               
               
                   
               
             
          
           
               
                 1 
                  0.7 ml 
                 500 
                 5 weeks 
                 Grow 
               
               
                 2 
                 0.525 ml 
                 750 
                 5 weeks 
                 Grow 
               
               
                 3 
                  0.35 ml 
                 1000 
                 5 weeks 
                 Grow 
               
               
                   
               
             
          
         
       
     
     Explanation of Drug Susceptibility Testing of Bacteria Growth: 
     Since basic fuchsine is non-toxic, in drug susceptibility testing, place basic fuchsine into the Lowenstein-Jensen medium will only cause the changes in color but no toxicity will be caused by the culture medium, and no nutrients content of the Lowenstein-Jensen medium will be affected. Also, since the medium does not provide a somatic environment, the bacteria should grow normally in this medium. This further proves that basic fuchsine is non-toxic, and that the fuchsine itself does not have a killing effect on the acid-fast bacilli killing effect. Instead, the basic fuchsine increases the pH of body fluid and stain the bacteria to become the target, thus the immunity system is activated to remove the bacteria thoroughly. This is the greatest advantage of this drug. 
     If standard drug is placed inside the Lowenstein-Jensen medium, this equals to giving toxic substances to the food of the bacteria, therefore the bacteria cannot grow because of food poisoning, therefore causing to the culture result as bacteria cannot grow (drug susceptibility). In other words, standard drugs can only have inhibition effect and fail to remove the bacteria thoroughly. Also, serious side effect may be resulted and damage to human detoxification is caused. 
     Important characteristics of using basic fuchsine to treat  Mycobacterium tuberculosis  and  Mycobacterium leprae  are summarized as follows: 
     1. Because basic fuchsine can increase pH of the body, causing the bacteria to lose its pH regulation effect, that unable to suppress phagocytes to secret plasmin, thus the fusion of lysosomes and phagosome will lead to the removal of bacteria. 
     2. Since basic fuchsine can stain the bacteria, while causing an increase in body pH, therefore the bacteria is tagged while the immunity is increased. Accordingly, the phagocytes is capable of identifying the target and has an increased engulfing ability to eliminate the bacteria. 
     3. Since basic fuchsine is intoxic, that its function mechanism is different from existing drug and it cannot inhibit or kill bacteria by toxicity effect, therefore during in vitro drug susceptibility, the bacteria cannot be killed and can growth normally in the culture medium due to the lack of somatic environment. 
     Embodiment 4 
     Basic Fuchsine for treatment of  Tuberculosis    
     Dosage for patient: Capsule, 500 mg/capsule, where the weight ratio of basic fuchsine to ground rice is 3:2, each patient takes 1˜2 capsule/day. 
     Method of administration: Every morning, before breakfast, take the capsule, three month as one treatment course, see Table 5 for patients&#39; records, see Table 6 for treatment results. 
     Explanation for Patients&#39; Records: 
     1. All patients were diagnosis and confirmed by standard TB hospital or TB prevention and treatment center, and all patients encountered disease recurrence after conventional standard drug treatment. 
     2. The patients, after conventional standard drug treatment, experienced liver and kidney damages of different level, and can no longer accept conventional standard drug. 
     3. Before drug treatment with basic fuchsine drug, all patients have obvious symptoms: body weakness, discomfort, fever, cough, night sweat, ascites, blood spitting, blood vomiting, etc. (skeletal TB patient experience pain, some experience amenorrhea). 
     4. Symptoms are significantly reduces after taking basic fuchsine for one month for majority of patients, TB symptoms are eliminated after taking basic fuchsine for three months, recovery are confirmed through X-ray after taking basic fuchsine for six months 
     5. Patients&#39; blood test for liver and kidney after taking basic fuchsine shows that the blood test results are normal. 
     6. After taking basic fuchsine for one month, no  M. tuberculosis  is found in sputum (no acid-fast bacilli is found). After taking basic fuchsine for six month, the course of treatment is complete. Normal lives can be resumed physical labor activities can be done. 
     
       
         
               
             
               
               
               
               
               
               
             
           
               
                 TABLE 5 
               
             
             
               
                   
               
               
                 Patients&#39; records of TB Patients 
               
             
          
           
               
                 Patent 
                   
                   
                 Sputum 
                 Side Effect of 
                   
               
               
                 Sex 
                 Place of 
                 Name of 
                 Acid-Fast 
                 Convention 
               
               
                 Age 
                 diagnosis 
                 disease 
                 Bacilli 
                 treatment 
                 Disease Condition 
               
               
                   
               
               
                 Li XX 
                 Shenyang 
                 Pulmonary 
                 TB(+) 
                 Dizziness, 
                 Cough, sputum 
               
               
                 F 
                 Chest 
                 TB 
                   
                 nausea, cannot 
                 with blood, whole 
               
               
                 65 
                 Hospital 
                   
                   
                 eat, vomiting, 
                 body weakness, 
               
               
                   
                   
                   
                   
                 very high uric 
                 low-grade fever 
               
               
                   
                   
                   
                   
                 acid test result, 
                 with increased 
               
               
                   
                   
                   
                   
                 high 
                 seriousness in the 
               
               
                   
                   
                   
                   
                 transaminase test 
                 afternoon, night 
               
               
                   
                   
                   
                   
                 result 
                 sweat 
               
               
                 Zhao XX 
                 Jilin TB 
                 Cavitary TB 
                 TB(+) 
                 Liver and kidney 
                 Whole body 
               
               
                 F 
                 Hospital 
                   
                   
                 damage 
                 weakness, fatigue, 
               
               
                 38 
                   
                   
                   
                   
                 cough, low-grade 
               
               
                   
                   
                   
                   
                   
                 fever, face 
               
               
                   
                   
                   
                   
                   
                 flushing, night 
               
               
                   
                   
                   
                   
                   
                 sweat, amenorrhea 
               
               
                 Yu XX 
                 Jilin TB 
                 Secondary 
                 TB(+) 
                 Nausea, 
                 Year round hands 
               
               
                 M 
                 Prevention 
                 TB 
                   
                 vomiting, 
                 and foot fever, 
               
               
                 48 
                 and 
                   
                   
                 dizziness, liver 
                 weakness, cough, 
               
               
                   
                 Treatment 
                   
                   
                 and kidney 
                 night sweat, 
               
               
                   
                 Center 
                   
                   
                 damage, elevated 
                 weight loss 
               
               
                   
                   
                   
                   
                 transaminase and 
               
               
                   
                   
                   
                   
                 uric acid 
               
               
                 Zhang XX 
                 Liaoyuan 
                 Thoracic 
                 CT Scan 
                 Dizziness, 
                 Relied on 
               
               
                 F 
                 City TB 
                 vertebrae 
                 TB(+) 
                 nausea, liver and 
                 painkiller, cannot 
               
               
                 62 
                 Hospital 
                 TB 
                   
                 kidney damage, 
                 lie up and down 
               
               
                   
                   
                   
                   
                 high 
                 by herself, sharp 
               
               
                   
                   
                   
                   
                 transaminase 
                 pain when 
               
               
                   
                   
                   
                   
                   
                 coughing 
               
               
                 Dong XX 
                 Jilin TB 
                 Infiltrate 
                 TB(+) 
                 Nausea, vomit, 
                 fever with 
               
               
                 F 
                 Hospital 
                 Pulmonary 
                   
                 dizziness, 
                 increased 
               
               
                 60 
                   
                 TB 
                   
                 fatigue, whole 
                 seriousness in the 
               
               
                   
                   
                   
                   
                 body weakness, 
                 afternoon, night 
               
               
                   
                   
                   
                   
                 high 
                 sweat, cough, 
               
               
                   
                   
                   
                   
                 transaminase 
                 whole body 
               
               
                   
                   
                   
                   
                   
                 weakness, fatigue 
               
               
                 Yu XX 
                 Jilin TB 
                 Pulmonary 
                 TB(+) 
                 Serious drug 
                 Cough, fever, 
               
               
                 M 
                 Hospital 
                 TB 
                   
                 reaction, cannot 
                 night sweat, 
               
               
                 43 
                   
                   
                   
                 eat, high 
                 weakness, fatigue, 
               
               
                   
                   
                   
                   
                 transaminase and 
                 whole body 
               
               
                   
                   
                   
                   
                 uric acid 
                 discomfort, 
               
               
                   
                   
                   
                   
                   
                 weight loss 
               
               
                 Jiang XX 
                 Shenyang 
                 Pulmonary 
                 TB(+) 
                 Nausea, vomit, 
                 Cough, fever, 
               
               
                 M 
                 Dongling 
                 TB 
                   
                 cannot eat, high 
                 night sweat, 
               
               
                 26 
                 Hospital 
                   
                   
                 transaminase and 
                 weakness, fatigue, 
               
               
                   
                   
                   
                   
                 uric acid 
                 whole body 
               
               
                   
                   
                   
                   
                   
                 discomfort 
               
               
                 Wu XX 
                 Jilin TB 
                 Miliary TB 
                 TB(+) 
                 Nausea, vomit, 
                 Cough, low-grade 
               
               
                 M 
                 Hospital 
                   
                   
                 dizziness, weight 
                 fever with 
               
               
                 21 
                   
                   
                   
                 loss, high 
                 increased 
               
               
                   
                   
                   
                   
                 transaminase and 
                 seriousness in the 
               
               
                   
                   
                   
                   
                 uric acid 
                 afternoon, fact 
               
               
                   
                   
                   
                   
                   
                 rash, night sweat, 
               
               
                   
                   
                   
                   
                   
                 weakness 
               
               
                 Yan XX 
                 Shenyang 
                 Cavitary TB 
                 TB(+) 
                 No improvement 
                 Cough, night 
               
               
                 F 
                 Chest 
                   
                   
                 after treatment 
                 sweat, body 
               
               
                 22 
                 Hospital 
                   
                   
                 (many times), 
                 weakness, 
               
               
                   
                   
                   
                   
                 liver and kidney 
                 aggregated flu, 
               
               
                   
                   
                   
                   
                 damage, 
                 liver and kidney 
               
               
                   
                   
                   
                   
                 hydrothorax, 
                 damage, 
               
               
                   
                   
                   
                   
                 significant lower 
                 weakness, 
               
               
                   
                   
                   
                   
                 back pain 
                 menstruation 
               
               
                   
                   
                   
                   
                   
                 amenorrhea 
               
               
                 Wu XX 
                 Heilongjiang 
                 Neck and 
                 TB(+) 
                 Insignificant 
                 Serious cough, 
               
               
                 F 
                 Military 
                 armpit 
                   
                 treatment result 
                 weakness, fatigue, 
               
               
                 63 
                 Hospital 
                 lymph nodes 
                   
                 with relief only, 
                 enlarged neck and 
               
               
                   
                   
                 TB 
                   
                 recurrence 
                 armpit lymph 
               
               
                   
                   
                   
                   
                 repeatedly, 
                 nodes, with 
               
               
                   
                   
                   
                   
                 dizziness, vomit, 
                 hardening and 
               
               
                   
                   
                   
                   
                 nausea, weakness 
                 pain 
               
               
                   
                   
                   
                   
                 is aggravate 
               
               
                 Yu XX 
                 Siping TB 
                 Pulmonary 
                 TB(+) 
                 Nausea, 
                 Cough, sputum 
               
               
                 F 
                 Hospital 
                 TB 
                   
                 vomiting, 
                 production, 
               
               
                 69 
                   
                   
                   
                 dizziness, liver 
                 occasional low- 
               
               
                   
                   
                   
                   
                 and kidney 
                 grade fever, 
               
               
                   
                   
                   
                   
                 damage 
                 weakness, fatigue 
               
               
                 Sun XX 
                 Siping TB 
                 Cavitary TB 
                 TB(+) 
                 dizziness Nausea, 
                 Cough, low-grade 
               
               
                 M 
                 Hospital 
                   
                   
                 liver and kidney 
                 fever, weakness, 
               
               
                 32 
                   
                   
                   
                 damage, 
                 fatigue, weight 
               
               
                   
                   
                   
                   
                 weakness, night 
                 loss 
               
               
                   
                   
                   
                   
                 sweat 
               
               
                 Hou XX 
                 Siping TB 
                 Pulmonary 
                 TB(+) 
                 Nausea, anorexia, 
                 Low-grade fever, 
               
               
                 M 
                 Hospital 
                 TB 
                   
                 increased 
                 night sweat, 
               
               
                 60 
                   
                   
                   
                 heartbeat, 
                 whole body 
               
               
                   
                   
                   
                   
                 weakness, high 
                 weakness, cough 
               
               
                   
                   
                   
                   
                 transaminase 
               
               
                 Qi XX 
                 Shenyang 
                 Pulmonary 
                 TB(+) 
                 Nausea, 
                 Cough, low-grade 
               
               
                 F 
                 No. 2 TB 
                 TB 
                   
                 dizziness, liver 
                 fever, weakness, 
               
               
                 62 
                 Hospital 
                   
                   
                 and kidney 
                 fatigue 
               
               
                   
                   
                   
                   
                 damage 
               
               
                 Meng XX 
                 Shenyang 
                 Pulmonary 
                 TB(+) 
                 Nausea, anorexia, 
                 Cough, easy to get 
               
               
                 M 
                 Dongling 
                 TB 
                   
                 liver and kidney 
                 a flu, night sweat, 
               
               
                 51 
                 TB Hospital 
                   
                   
                 damage, elevated 
                 fatigue, weakness 
               
               
                   
                   
                   
                   
                 transaminase 
               
               
                 Zhou XX 
                 Fushun TB 
                 Pulmonary 
                 TB(+) 
                 Nausea, 
                 Cough, weakness, 
               
               
                 F 
                 Hospital 
                 TB 
                   
                 increased 
                 fatigue, 
               
               
                 77 
                   
                   
                   
                 heartbeat, liver 
                 drowsiness, easy 
               
               
                   
                   
                   
                   
                 and kidney 
                 to catch a cold 
               
               
                   
                   
                   
                   
                 damage 
               
               
                 Li XX 
                 Fushun TB 
                 Pulmonary 
                 TB(+) 
                 Headache, 
                 Cough, sputum 
               
               
                 F 
                 Hospital 
                 TB 
                   
                 anorexia, liver 
                 production, 
               
               
                 49 
                   
                   
                   
                 and lung 
                 weakness, night 
               
               
                   
                   
                   
                   
                 damage, high 
                 sweat, fatigue, 
               
               
                   
                   
                   
                   
                 transaminase 
                 whole body 
               
               
                   
                   
                   
                   
                   
                 discomfort 
               
               
                 Li XX 
                 Fushun TB 
                 Tuberculosis 
                 TB(+) 
                 Nausea, 
                 Weak, fatigue, 
               
               
                 M 
                 Hospital 
                 Pleurisy 
                   
                 headache, 
                 discomfort, low- 
               
               
                 48 
                   
                   
                   
                 anorexia, liver 
                 grade fever, night 
               
               
                   
                   
                   
                   
                 and kidney 
                 sweat, chest pain, 
               
               
                   
                   
                   
                   
                 damage, 
                 cough 
               
               
                   
                   
                   
                   
                 terminated 
               
               
                   
                   
                   
                   
                 treatment, 
               
               
                   
                   
                   
                   
                 thoracentesis 4 
               
               
                   
                   
                   
                   
                 times 
               
               
                 Zhang XX 
                 Zhangchun 
                 Double 
                 TB(+) 
                 Whole body 
                 Cough, low fever, 
               
               
                 F 
                 TB Hospital 
                 Miliary TB 
                   
                 weakness, 
                 more serious in 
               
               
                 26 
                   
                   
                   
                 nausea, anorexia, 
                 the afternoon, 
               
               
                   
                   
                   
                   
                 dizziness, liver 
                 night sweat 
               
               
                   
                   
                   
                   
                 and kidney 
               
               
                   
                   
                   
                   
                 damage 
               
               
                 Wamg XX 
                 Jilin Jiutai 
                 Double 
                 TB(+) 
                 Nausea, anorexia, 
                 Cough, blooding 
               
               
                 M 
                 TB Hospital 
                 Miliary TB, 
                   
                 headache, liver 
                 spitting, whole 
               
               
                 40 
                   
                 3 cavity in 
                   
                 and kidney 
                 body weakness, 
               
               
                   
                   
                 the lung 
                   
                 damage 
                 low-grade fever, 
               
               
                   
                   
                   
                   
                   
                 night sweat, 
               
               
                   
                   
                   
                   
                   
                 bedrest, weight 
               
               
                   
                   
                   
                   
                   
                 loss 
               
               
                   
               
             
          
         
       
     
     
       
         
               
             
               
               
               
               
               
             
           
               
                 TABLE 6 
               
             
             
               
                   
               
               
                 Treatment results of TB Patients 
               
             
          
           
               
                 Patent 
                 Dosage 
                   
                   
                   
               
               
                 Sex 
                 (capsule/ 
                 Drug treatment after 
                 Drug treatment after 
                 Drug treatment after 
               
               
                 Age 
                 day) 
                 1 month 
                 3 month 
                 6 month 
               
               
                   
               
               
                 Li XX 
                 1 
                 TB Improved (−) 
                 Resume physical 
                 TB (−) confirmed by 
               
               
                 F 
                   
                   
                 strength, TB symptoms 
                 X-ray, liver and 
               
               
                 65 
                   
                   
                 such as fatigue are 
                 kidney function 
               
               
                   
                   
                   
                 eliminated 
                 normal 
               
               
                 Zhao XX 
                 1 
                 TB Improved (−) 
                 Symptoms of night 
                 TB (−) confirmed by 
               
               
                 F 
                   
                 normal 
                 sweat, cough, weakness 
                 X-ray, liver and 
               
               
                 38 
                   
                 menstruation 
                 low-grade fever are 
                 kidney function 
               
               
                   
                   
                   
                 eliminated 
                 normal 
               
               
                 Yu XX 
                 1 
                 TB Improved (−) 
                 Resume physical 
                 TB (−) confirmed by 
               
               
                 M 
                   
                   
                 strength, symptoms of 
                 X-ray, liver and 
               
               
                 48 
                   
                   
                 cough night sweat and 
                 kidney function 
               
               
                   
                   
                   
                 low-grade fever are 
                 normal 
               
               
                   
                   
                   
                 eliminated 
               
               
                 Zhang XX 
                 2 
                 Pain reduced 
                 Resume physical 
                 liver and kidney 
               
               
                 F 
                   
                   
                 strength, pain is 
                 function normal, no 
               
               
                 62 
                   
                   
                 relieved, stop use of 
                 significant changes in 
               
               
                   
                   
                   
                 painkiller 
                 X-ray 
               
               
                 Dong XX 
                 1 
                 Reduced symptoms 
                 Resume physical 
                 TB (−) confirmed by 
               
               
                 F 
                   
                 of cough and others 
                 strength, TB symptoms 
                 X-ray, liver and 
               
               
                 60 
                   
                   
                 are eliminated 
                 kidney function 
               
               
                   
                   
                   
                   
                 normal 
               
               
                 Yu XX 
                 1 
                 Cough and night 
                 Resume physical 
                 TB (−) confirmed by 
               
               
                 M 
                   
                 sweat disappeared, 
                 strength, symptoms of 
                 X-ray, liver and 
               
               
                 43 
                   
                 Improved 
                 cough, weakness and 
                 kidney function 
               
               
                   
                   
                   
                 night sweat are 
                 normal 
               
               
                   
                   
                   
                 eliminated 
               
               
                 Jiang XX 
                 1 
                 Normal 
                 All TB symptoms are 
                 TB (−) confirmed by 
               
               
                 M 
                   
                 transaminase 
                 eliminated 
                 X-ray, liver and 
               
               
                 26 
                   
                 TB (−) 
                   
                 kidney function 
               
               
                   
                   
                   
                   
                 normal 
               
               
                 Wu XX 
                 1 
                 Normal 
                 All TB symptoms are 
                 TB (−) confirmed by 
               
               
                 M 
                   
                 transaminase 
                 eliminated, physical 
                 X-ray, liver and 
               
               
                 21 
                   
                 TB (−) 
                 strength is improved 
                 kidney function 
               
               
                   
                   
                   
                   
                 normal 
               
               
                 Yan XX 
                 1 
                 No lower back 
                 All TB symptoms are 
                 TB (−) confirmed by 
               
               
                 F 
                   
                 pain, normal 
                 eliminated, physical 
                 X-ray, liver and 
               
               
                 22 
                   
                 menstruation, TB (−) 
                 strength is improved, 
                 kidney function 
               
               
                   
                   
                   
                 ascites dissappeared 
                 normal 
               
               
                 Wu XX 
                 1 
                 Improved, 
                 Resume physical 
                 TB (−), neck and 
               
               
                 F 
                   
                 softening of hard 
                 strength, all TB 
                 armpit tubercles 
               
               
                 63 
                   
                 tissue 
                 symptoms are 
                 disappeared 
               
               
                   
                   
                   
                 eliminated 
               
               
                 Yu XX 
                 1 
                 Improved TB (−) 
                 Feel body strength, 
                 TB (−) confirmed by 
               
               
                 F 
                   
                   
                 cough is gone, not 
                 X-ray, liver and 
               
               
                 69 
                   
                   
                 fatigue anymore, low- 
                 kidney function 
               
               
                   
                   
                   
                 grade fever 
                 normal 
               
               
                   
                   
                   
                 disappaeared 
               
               
                 Sun XX 
                 1 
                 Significantly 
                 Resume physical 
                 TB (−) confirmed by 
               
               
                 M 
                   
                 improved TB (−) 
                 strength, weight gain, 
                 X-ray, liver and 
               
               
                 32 
                   
                   
                 all TB symptoms are 
                 kidney function 
               
               
                   
                   
                   
                 eliminated 
                 normal 
               
               
                 Hou XX 
                 1 
                 Improved TB (−) 
                 Fatigue is gone, feel to 
                 TB (−) confirmed by 
               
               
                 M 
                   
                   
                 have strength, all all 
                 X-ray, liver and 
               
               
                 60 
                   
                   
                 TB symptoms are 
                 kidney function 
               
               
                   
                   
                   
                 eliminated 
                 normal 
               
               
                 Qi XX 
                 1 
                 Improved TB (−) 
                 Resume physical 
                 TB (−) confirmed by 
               
               
                 F 
                   
                   
                 strength, not fatigue 
                 X-ray, liver and 
               
               
                 62 
                   
                   
                 anymore, all TB 
                 kidney function 
               
               
                   
                   
                   
                 symptoms are 
                 normal 
               
               
                   
                   
                   
                 eliminated 
               
               
                 Meng XX 
                 1 
                 Improved TB (−) 
                 Cough disappeared, 
                 TB (−) confirmed by 
               
               
                 M 
                   
                   
                 whole body with 
                 X-ray, liver and 
               
               
                 51 
                   
                   
                 strength again, all TB 
                 kidney function 
               
               
                   
                   
                   
                 symptoms are 
                 normal 
               
               
                   
                   
                   
                 eliminated 
               
               
                 Zhou XX 
                 1 
                 Improved TB (−) 
                 fatigue disappeared, 
                 TB (−) confirmed by 
               
               
                 F 
                   
                   
                 cough is gone, all TB 
                 X-ray, liver and 
               
               
                 77 
                   
                   
                 symptoms are 
                 kidney function 
               
               
                   
                   
                   
                 eliminated 
                 normal 
               
               
                 Li XX 
                 1 
                 Improved TB (−) 
                 Feel improved physical 
                 TB (−) confirmed by 
               
               
                 F 
                   
                   
                 strength, fatigue and all 
                 X-ray, liver and 
               
               
                 49 
                   
                   
                 TB symptoms are 
                 kidney function 
               
               
                   
                   
                   
                 eliminated 
                 normal 
               
               
                 Li XX 
                 1 
                 Significantly 
                 improved physical 
                 TB (−) confirmed by 
               
               
                 M 
                   
                 improved TB (−) 
                 strength, all TB 
                 X-ray, liver and 
               
               
                 48 
                   
                   
                 symptoms are 
                 kidney function 
               
               
                   
                   
                   
                 eliminated, ascites 
                 normal 
               
               
                   
                   
                   
                 disappeared 
               
               
                 Zhang XX 
                 1 
                 Improved TB (−) 
                 Cough and all TB 
                 TB (−) confirmed by 
               
               
                 F 
                   
                   
                 symptoms are 
                 X-ray, liver and 
               
               
                 26 
                   
                   
                 eliminated 
                 kidney function 
               
               
                   
                   
                   
                   
                 normal 
               
               
                 Wang XX 
                 1 
                 Improved TB (−) 
                 all TB symptoms are 
                 TB (−) confirmed by 
               
               
                 M 
                   
                   
                 eliminated, feel 
                 X-ray, liver and 
               
               
                 40 
                   
                   
                 improved physical 
                 kidney function 
               
               
                   
                   
                   
                 strength, weight gain 
                 normal 
               
               
                   
               
             
          
         
       
     
     Embodiment 5 
     Basic Fuchsine for Treatment of Leprosy: 
     I. Type of drug: 
     1. Oral capsule: Dosage for patient: Capsule, 500 mg/capsule, where the weight ratio of basic fuchsine to ground rice is 3:2, each patient takes 1˜2 capsule/day; 
     2. Topical tincture, apply to ulcer surface. 
     II. Preparation of Basic Fuchsine Tincture: 
     Materials: 1. Basic fuchsine, 2. Medical alcohol (75% ethanol solution) 
     Preparation Process: 
     1. Pour 100 g basic fuchsine and 800 ml 75% ethanol into a glass beaker, then stir evenly by a glass rod. 
     2. Grip an alcohol cotton with forceps, light up by a lighter and place to the surface of the beaker which contains basic fuchsine and 75% ethanol, ignite the mixture, stir with the glass rod while burning until the flame is out. 
     3. Wait till the temperature reached 60° C., then pour the drug solution after burning into a grinding jar through a funnel. 
     4. Soaking the prepared tincture solution into cotton ball in an auxiliary tank. 
     III. Method of Use 
     External use: wash the ulcer surface of leprosy patients with saline, then apply the cotton ball which is prepared with basic fuchsine tincture solution, apply repeatedly and then wrap by gauze. Repeat the above steps every 3 days until the wound is healed. 
     Internal use: Every morning before breakfast, take 1 capsule with warm water until recovery. One treatment course is three months. See Table 7 for treatment results. 
     Explanation for patients&#39; records: The subjects are patients from Shandong Tengzhou City Leprosy Village and patients from Leprosy Rehabilitation Center of Puguang Hospital in Wuchaun City, Guangdong Province. 
     
       
         
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 7 
               
             
             
               
                   
               
               
                 Patient&#39;s records of Leprosy Patients 
               
             
          
           
               
                   
                   
                   
                   
                 Condition 
                   
                   
                   
               
               
                 Patent 
                 Name 
                 Years 
                 Convention 
                 before 
               
               
                 Sex 
                 of 
                 of 
                 treatment 
                 Fuchsine 
                 Treatment 
                 Treatment 
               
               
                 Age 
                 disease 
                 Ulcer 
                 method 
                 Treatment 
                 method 
                 results 
                 Remarks 
               
               
                   
               
               
                 Du XX 
                 Leprosy 
                 More 
                 Serious 
                 Cannot 
                 Oral and 
                 After oral 
                 After 
               
               
                 M 
                 ulcers 
                 than 60 
                 drug 
                 sleep due 
                 external 
                 treatment 
                 treatment 
               
               
                 81 
                   
                 years 
                 reaction, 
                 to pain, 
                   
                 for 7 days, 
                 for 1 
               
               
                   
                   
                   
                 increased 
                 swollen 
                   
                 leg&#39;s 
                 month, 
               
               
                   
                   
                   
                 ulcer area, 
                 and red 
                   
                 swelling 
                 scab is 
               
               
                   
                   
                   
                 bone pain 
                 calf 
                   
                 and redness 
                 formed on 
               
               
                   
                   
                   
                   
                   
                   
                 disappeared, 
                 the ulcer 
               
               
                   
                   
                   
                   
                   
                   
                 ulcer area is 
                 area 
               
               
                   
                   
                   
                   
                   
                   
                 reduced 
               
               
                 Zhang 
                 Leprosy 
                 More 
                 Palpitation, 
                 Swollen 
                 Oral and 
                 After oral 
                 After 
               
               
                 XX 
                 ulcers 
                 than 40 
                 nausea, 
                 and red 
                 external 
                 treatment 
                 treatment 
               
               
                 M 
                   
                 years 
                 anorexia 
                 finger, 
                   
                 for 10 days, 
                 for 1 
               
               
                 68 
                   
                   
                   
                 sticky, 
                   
                 swelling 
                 month, 
               
               
                   
                   
                   
                   
                 ulcer on 
                   
                 and redness 
                 scab is 
               
               
                   
                   
                   
                   
                 feet 
                   
                 disappeared, 
                 formed on 
               
               
                   
                   
                   
                   
                   
                   
                 foot ulcer 
                 the ulcer 
               
               
                   
                   
                   
                   
                   
                   
                 area is 
                 area, hands 
               
               
                   
                   
                   
                   
                   
                   
                 reduced 
                 are healed 
               
               
                 Cao XX 
                 Leprosy 
                 Few 
                 Used many 
                 Ulcer and 
                 External 
                 After half 
                 Absorbed, 
               
               
                 M 
                 ulcers 
                 decades 
                 external 
                 bleeding 
                   
                 month, area 
                 continue 
               
               
                 76 
                   
                   
                 medication 
                 on two 
                   
                 of ulcer is 
                 treatment 
               
               
                   
                   
                   
                 but 
                 feet 
                   
                 reduced, 
               
               
                   
                   
                   
                 ineffective 
                   
                   
                 scab is 
               
               
                   
                   
                   
                   
                   
                   
                 formed at 
               
               
                   
                   
                   
                   
                   
                   
                 the edges 
               
               
                 Liu XX 
                 Leprosy 
                 Many 
                 Used many 
                 Ulcer on 
                 External 
                 scab formed 
                 Continuous 
               
               
                 M 
                 ulcers 
                 years 
                 external 
                 one foot 
                 use of 
                 after half 
                 monitoring 
               
               
                 70 
                   
                   
                 medication 
                   
                 tincture 
                 month 
               
               
                   
                   
                   
                 but 
               
               
                   
                   
                   
                 ineffective 
               
               
                 Chen 
                 Leprosy 
                 45 
                 Used many 
                 Pus and 
                 External 
                 scab formed 
                 Pain 
               
               
                 XX 
                 ulcers 
                 years 
                 external 
                 pain on 
                 use of 
                 after half 
                 disappeared 
               
               
                 M 
                   
                   
                 medication 
                 one foot 
                 tincture 
                 month 
                 on the day 
               
               
                 66 
                   
                   
                 but 
                   
                   
                   
                 of 
               
               
                   
                   
                   
                 ineffective 
                   
                   
                   
                 application 
               
               
                   
               
             
          
         
       
     
     One skilled in the art will understand that the embodiment of the present invention as shown in the drawings and described above is exemplary only and not intended to be limiting. It will thus be seen that the objects of the present invention have been fully and effectively accomplished. It embodiments have been shown and described for the purposes of illustrating the functional and structural principles of the present invention and is subject to change without departure from such principles. Therefore, this invention includes all modifications encompassed within the spirit and scope of the following claims.