Abstract:
The present invention is related to a botanical extract, called P Compound, comprises anti-infection activities. The botanical sources, extracting process, formulation, and applications are disclosed within this invention.

Description:
REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims the benefit of the filing date of U.S. Provisional Application Ser. No. 61/163,960, entitled “Anti-infection P-compound™” and filed on Mar. 27, 2009. The teachings of the entire referenced application are incorporated herein by references. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates generally to natural compounds called “P Compound™” extracted from a botanical base source and methods of applying such compounds for topical external applications to eliminate infectious microbes on exposed surfaces, on humans and on livestock and reliably inhibit re-growth of bacteria, virus, fungus, parasite, and the like. 
       BACKGROUND OF THE INVENTION 
       [0003]    According to a science report from  Science Daily  (Dec. 6, 2007), hospitalizations related to a potentially deadly, antibiotic-resistant “super bug” more than doubled between 1999 and 2005, soaring from 127,000 to nearly 280,000. Mutated bacteria and virus microorganisms are sources of rapidly mounting serious infection throughout the world. These so called Super Bugs are prolific, stubbornly antibiotic resistant, highly contagious and a major concern for public health officials. 
         [0004]    Antibiotic-resistant infections also impose greater costs. Several studies have estimated that antibiotic-resistant infections increase direct costs by 30 percent to 100 percent. MRSA-specific studies suggest that the additional cost of treating an antibiotic-resistant staph infection versus an antibiotic-sensitive infection range from a minimum of $3,000 to more than $35,000 per case. This suggests that such infections cost the health care system an extra $830 million to $9.7 billion in 2005, even without taking into account indirect costs related to patient pain, illness, and time spent in the hospital. 
         [0005]    Staph, or  Staphylococcus aureus , is a kind of bacteria that infect wounds and cause life-threatening infections, such as blood poisoning and pneumonia. The spread of staph has been formally grouped into two primary subsets: Health Care-Acquired infection in a hospital, clinic or dental care facility and Community-Acquired infection spreading to public venues such as schools. 
         [0006]    One such super bug is called “MRSA” methicillin-resistant  Staphylococcus aureus  (MRSA), which is becoming prevalent in the broader community and already causing thousands of deaths each year in the United States. 
         [0007]    MRSA belongs to a genus of bacteria—more than 30 types—called  Staphylococcus , or just “staph.” Staphylococci are found in about 30% of adults, mostly on the skin or in the nose. Most people who carry the bug are healthy; they are said to be “colonized” but not infected. Most infections occur when one type of staph— Staphylococcus aureus —gets into the body through a break in the skin, such as a cut or burn. Even then, it usually causes only minor symptoms, such as small pimples or boils that can be treated without antibiotics. But staph infection can be very serious for people whose immune systems are weakened by age, illness, or chemotherapy. They may develop a deep abscess or life-threatening infection in the bloodstream, urinary tract, lungs, or surgical wounds. 
         [0008]    Most serious staph infections can be successfully treated with methicillin, which belongs to the penicillin class of antibiotics. MRSA infections are resistant to this group of antibiotics, but they usually do respond to other, more potent antibiotics, particularly vancomycin. The trouble is that it may take a day or two to determine whether a given infection is caused by ordinary staph or MRSA. Because of the delay, patients infected with MRSA have longer hospital stays and worse outcomes, including higher death rates, than those with staph infections that are not resistant to methicillin. 
         [0009]    MRSA are “super bugs” that have evolved resistance to most commonly used antibiotics, so they are more difficult and expensive to treat. MRSA and staph infections are now epidemic in many U.S. hospitals, long-term care facilities and communities. In all likelihood, MRSA infections are spreading in both hospitals and communities, complicating efforts to prevent infections in hospital patients. Hospital-acquired infections from all causes result in an estimated 90,000 deaths per year and are the sixth-leading cause of death nationally. They also increase patient suffering and the length of time patients spend in the hospital—in addition to direct health care costs, estimated to be more than $6 billion annually. 
         [0010]    The National Centers for Disease Control and Prevention&#39;s Top 20 list ranks staph bacteria/MRSA #3 ahead of Autism, Pandemic Flu and Heart Disease (www.cdc.gov.). Traditional antiseptic/disinfectant products used by health care institutions and available to the public through retail outlets are unable to control or eliminate mobile ever-present Super Bugs. 
         [0011]    Highly resistant mutant microorganisms are a persistent presence at the alarming level in all health care centers. Statistically, it has reached epidemic proportions with a ten-fold increase in debilitating, too often lethal, infection. Causes are invasive procedures on patients such as intravenous blood stream, organ surgery, catheters, skin punctures and through body openings. 
         [0012]    Widespread use of lifesaving antibiotic drugs has led to the rise of mutated drug-resistant bacteria, or “super bugs,” which are outwitting even our newest and most powerful antibiotics. There is an emergency need for any natural compound (not antibiotics), which could eliminate these “super bugs”. 
         [0013]    The present invention provides P Compound entirely extracted from natural plant source and the methods of using the same for an anti-infection purpose. 
       SUMMARY OF THE INVENTION 
       [0014]    The present invention is related to anti-infection P Compound that are extracted from a combination of  Camellia Sinensis, Yerbe Mate , and  Rooibos  that are botanically sourced natural substances and such P Compound are used as proprietary formula topical medicines. 
         [0015]    Topical P Compound in 100% natural formula, as a solo ingredient or primary ingredient additive, prevents infection by eliminating the presence of anti-biotic resistant bacteria and virus. Such topical antiseptic applications, without adding any extra chemical/anti-biotic supplement ingredients, effectively satisfy the needs of anti-infection natural solution. 
         [0016]    Such botanical P Compound was extracted from a natural plant base source when combined with a liquid solution, which creates a formula for a topical antiseptic application. The method of applying P Compound eliminates the presence and re-growth of bacteria and virus types including MRSA that are harmful to humans and livestock. For example, P Compound completely destroyed the gram-positive bacteria (including  Staphylococcus aureus, Bacillus cereus, Micrococcus luteus, Enterococcus faecium ) and gram-negative bacteria (including  Salmonella enteritides, Proteus vulgaris, Serratia marcescens, Psedumonas aeruginosa, Enterobacter aerogenes, Escherichia coli, Chromobacterium violaceum ). 
         [0017]    One topical application of the P Compound on human skin and livestock or when applied to exposed surfaces reliably killed staph/MRSA et al antibiotic resistant bacteria and eliminated immediate return and colony re-growth. 
         [0018]    A lab test series confirmed one application of P Compound formula killed and continues to protect the treated area from the re-establishment of staph bacteria colonies for extended periods. In contrast, the generic ethyl alcohol based antiseptic products, due to rapid evaporation rates, required frequent applications and only resulted partial protection and did not eliminate most strains of highly resistant bacteria (Super bugs). 
         [0019]    Topical P Compound, as an additive or a line extension product in healthcare industry, are natural ingredient compound replacements for chemicals/antibiotics. Topical P Compound have broad applications for use with a variety of institutional and consumer product categories where the elimination of staph type bacteria/virus presence is critical. Such natural anti-infection products will benefit to generic unregulated topical products in the retail medical/dental sector such as antiseptic wipes/sprays/liquids/soaps and reconstitute polluting/ineffective antibacterial soaps containing triclosan/triclocarban active ingredients. 
         [0020]    This invented P Compound provides an alternative solution necessary to further control mutant forms of highly resistant microorganisms simultaneously addresses the concerns of every U.S. health care institution. These organizations are plagued by embarrassment, lawsuits and serious obstacles to professional healing standards. The credibility of these institutions would benefit greatly from products that effectively control, treat and eliminate the threat of Super Bug infection. 
         [0021]    The development of natural solutions based on P Compound offers The following advantages: longer term treatment stability, infection prevention control, and environment green/positive alternatives. 
         [0022]    P Compound ingredient additives upgrade existing antiseptic/disinfectant sector brands and foster expansion of new products with featured active ingredients in a number of institutional and consumer retail segments. When P Compound topical formulae are used as an additive ingredient mixed directly with the contents of an ethyl alcohol based antiseptic product it upgrades the efficacy of the product by eliminating populated colonies of  Staph aureus  MRSA, Strap mutants, and  E faecalis  bacteria. Similar experiments achieved the same result on Vancomycin resistant  Enterococcus  (VRE),  Salmonella  strains and Bacteriophage T1, which infects  Escherichia coli  B, was also adversely affected. 
         [0023]    In summary, the present invention provides a natural, safe and effective solution to deal with microorganism infection including Super Bugs such as MRSA. The unique P Compound formula invented within this invention makes P Compound suitable to apply alone or mix with other existing antiseptic products as ingredient additives. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0024]      FIG. 1  Laboratory test screen of P Compound, as additives to Purell 8 oz. size, killed Super bug  Staph aureus  MRSA in bacteria control colonies. 
           [0025]      FIG. 2  Laboratory test screen series of P Compound, as sole active ingredients, killed  Staph aureus  MRSA Super Bugs in bacteria control colonies. 
           [0026]      FIG. 3  Laboratory test screen series of P Compound, as sole active ingredients, killed  Bacillus cereus  Super Bugs in bacteria control colonies. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0027]      
         [0000]    
       
         
               
             
               
               
             
           
               
                   
               
               
                 P COMPOUND EXTRACT SOURCE 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 BOTANICAL NAMES: 
                   
               
               
                 TEA 
                   Camellia Sinensis , Unfermented 
               
               
                 ROOIBOS 
                 
                   Aspalathus linearis 
                 
               
               
                 YERBA MATE (MATE) 
                 
                   Ilex Paraguayensis 
                 
               
               
                 APPEARANCE: 
                 Brown Powder 
               
               
                 TASTE: 
                 Bitter/Astringent 
               
               
                 WATER SOLUBILITY: 
                 Soluble 
               
               
                 COMMON NAME: 
                 Tea Extract 
               
               
                 POLYPHENOL CONTENT: 
                 Minimum 74% 
               
               
                 CATECHIN CONTENT: 
                 Minimum 50% 
               
               
                 EGCG CONTENT: 
                 Minimum 24% 
               
               
                 MICROBIOLOGICAL DATA: 
               
               
                 YEAST 
                 Max 100 cfu/gram 
               
               
                 MOLD 
                 Max 100 cfu/gram 
               
               
                 TOTAL PLATE COUNT 
                 Max 1000 cfu/gram 
               
               
                 
                   E. Coli 
                 
                 Negative 
               
               
                 STORAGE: 
                 Ambient temperature; avoid moisture. 
               
               
                   
               
             
          
         
       
     
       P Compound Extraction Process: 
       [0028]    Raw materials from  Camellia Sinensis, Rooibos , and  Yerbe Mate  were suspended in hot water (80° C.), P Compound were extracted according the following steps: Extraction - - - Filtration - - - Cooling - - - Concentration - - - Cooling - - - Extracted by Ethyl Acetate - - - Concentrating the liquor with Centrifugation - - - Spraying and drying - - - Sifting and blending 
       P Compound Anti-Infection Effects: 
       [0029]    Clinical product testing was performed under the auspices of an independent microbiological laboratory(s). The test objective was to determine the feasibility/compatibility of a P (Prevent) Compound additive to the ingredients present in a well-established antiseptic brand. A quantity of P Compound formula, directly added to the leading antiseptic (ethyl alcohol based) packaged brand, produced unprecedented results. When P Compound direct additive ingredient was included, one topical application reliably and totally eliminated populated colonies of  Staph aureus  MRSA, Strap mutants and  E faecalis  bacteria. Conversely, absent the P Compound additive, topical pre-testing of this leading brand has determined repeated applications were unable to eliminate colonies comprised of the same drug resistant bacteria. See  FIG. 1  for comparative product test screen results (P formula screens illustrating the results of diluted and undiluted bacteria control zone of inhibition experiments). Also, a two-year series of clinical microbiological studies has been conducted. The result documents unprecedented success of P compound in reliably eliminating the presence of  Staph aureus , Strap mutants,  E faecalis , MRSA bacteria and BacteriophageT 1. 
         [0030]    Other leading national antiseptic brands under testing are unable to claim elimination of drug resistant Super Bugs such as Staph/MRSA bacteria/human viruses. 
         [0031]    In addition, early research trials with P Compound has demonstrated similar results in eliminating Vancomycin-Resistant  Enterococcus  (VRE), a new mutant strain of deadly  Enterococcus  bacteria for which there is no antibiotic drug cure. Typically, all the above referenced microorganisms begin as health care acquired infections with hospital/dental personnel as the initial carriers. 
         [0032]    For anti-bacteria testing, the antibacterial effect of P Compound on  S. aureus  and  B. cereus  was obtained by observing zones of inhibition of bacteria grown on Mannitol Salt agar (Kirby-Bauer technique). The zone of inhibition was equally pronounced for P compound and is significant in that we are unaware of other topically applied products, commercially available, offering this level of a solution. A series of photographs in support of these findings, based on diluted and undiluted bacteria control experiments, are enclosed herewith to serve as documentation of these results (See  FIG. 2  and  FIG. 3 ). 
         [0033]    Our results showed that the antibacterial effect of P Compound was significant. For example, 1% of P Compound dissolved in water totally destroyed  Staphylococcus aureus;  6% of P Compound dissolved in water totally destroyed  Salmonella enteritides . These natural extract compounds had a substantially greater effect on the gram positives than on the gram negatives. The antibacterial effects of these additives were obtained by observing zones of inhibition of bacteria grown on either Mueller Hinton II agar or Hektoen Enteric agar (Kirby-Bauer technique), and by direct plate counts of bacterial colonies grown on Tryptic Soy agar using the standard plate technique. The antibacterial effect of an instant hand sanitizer was also investigated. The addition of P Compound to an instant hand sanitizer destroyed  Staphylococcus aureus  and  Bacillus cereus . In absence of the additives, the hand sanitizer was ineffective. 
         [0034]    The following table 1 showed that the anti-MRSA effects of 7.5% of P Compound. 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                 Anti-MRSA effects of P Compound 
               
             
          
           
               
                   
                   
                 Test 
                   
                   
                   
                   
               
               
                   
                   
                 Population 
               
               
                   
                   
                 Control 
                 Number of 
                 Log 10   
               
               
                   
                 Exposure 
                 CFU/mL* 
                 Survivors 
                 Number of 
                 Percent 
                 Log 10   
               
               
                 Test Organism 
                 Time 
                 (Log 10 ) 
                 (CFU/mL)* 
                 Survivors 
                 Reduction 
                 Reduction 
               
               
                   
               
             
          
           
               
                 Methicillin 
                  1 minute 
                 5.6 × 10 5   
                 3.4 × 10 5   
                 5.53 
                    39.3% 
                 0.22 
               
               
                 Resistant 
                   
                 (5.75) 
               
               
                 
                   Staphylococcus 
                 
                  1 hour 
                 4.5 × 10 5   
                 &lt;5 
                 &lt;0.7 
                 &gt;99.99% 
                 &gt;4.95 
               
               
                 
                   aureus - 
                 
                   
                 (5.65) 
               
               
                 MRSA (ATCC 
                  6 hours 
                 6.3 × 10 5   
                 &lt;5 
                 &lt;0.7 
                 &gt;99.99% 
                 &gt;5.1 
               
               
                 33592) 
                   
                 (5.80) 
               
               
                   
                 24 hours 
                 3.3 × 10 5   
                 &lt;5 
                 &lt;0.7 
                 &gt;99.99% 
                 &gt;4.82 
               
               
                   
                   
                 (5.52) 
               
               
                   
               
               
                 *Colony forming units per mL of test mixture 
               
             
          
         
       
     
         [0035]    The following P Compound Test Results also showed that 1 ml of different concentrations of P Compound (0.2%; 2%; or 10%) with different exposing times to control MRSA bacteria could eliminate the growth or colony forming of bacteria significantly. 
         [0036]    Method 1. 1 ml of different concentrations of P Compound (0.2%; 2%; or 10%) was added to a TSA agar plate and then added 0.1 ml of MRSA bacterial organism with different dilutions and spread. Plates are placed in a 37° C. incubator and examined colonies of bacteria after 18-24 hours. 
         [0000]    
       
         
               
             
               
               
             
               
               
               
               
               
             
               
               
               
               
               
             
           
               
                   
               
               
                 Result from Method 1. 
               
               
                 MRSA Bacterial concentration = 21 × 10 8 /ml 
               
             
          
           
               
                   
                 Dilutions 
               
             
          
           
               
                   
                 10 −2   
                 10 −4   
                 10 −6   
                 10 −7   
               
               
                   
                   
               
             
          
           
               
                 Control 
                 Too much to 
                 Too much to count 
                 210 colonies 
                 21 colonies 
               
               
                   
                 count 
               
               
                 0.2% 
                 No Colony 
                 No Colony 
                 No Colony 
                 No Colony 
               
               
                 2.0% 
                 No Colony 
                 No Colony 
                 No Colony 
                 No Colony 
               
               
                 10.0%  
                 No Colony 
                 No Colony 
                 No Colony 
                 No Colony 
               
               
                   
               
               
                 Note: 
               
               
                 No Colony means total elimination of bacteria. 
               
             
          
         
       
     
         [0037]    Method 2. 1 ml of different concentrations of P Compound (0.2%; 2%; or 10%) was added to a TSA agar plate and then added 0.1 ml of MRSA bacterial organism with different dilutions and spread. Plates are placed in a 37° C. incubator and examined colonies of bacteria after 30 seconds and 15 minutes. 
         [0000]    
       
         
               
             
               
               
             
               
               
               
               
               
             
               
               
               
               
               
             
               
             
               
               
               
               
               
             
               
             
               
               
               
               
               
             
           
               
                   
               
               
                 Result from Method 2. 
               
               
                 MRSA Bacterial concentration = 29 × 10 8 /ml 
               
             
          
           
               
                   
                 Dilutions 
               
             
          
           
               
                   
                 10 −2   
                 10 −4   
                 10 −6   
                 10 −7   
               
               
                   
                   
               
             
          
           
               
                 Control 
                 Too much to count 
                 Too much 
                 290 colonies 
                 29 colonies 
               
               
                   
                   
                 to count 
               
             
          
           
               
                 30 seconds exposure 
               
             
          
           
               
                 0.2% 
                 Too much to count 
                 Too much 
                 38 colonies 
                 No Colony 
               
               
                   
                   
                 to count 
               
               
                 2.0% 
                 Some Colony 
                 No Colony 
                 No Colony 
                 No Colony 
               
               
                 10.0%  
                 No Colony 
                 No Colony 
                 No Colony 
                 No Colony 
               
             
          
           
               
                 15 minutes exposure 
               
             
          
           
               
                 0.2% 
                 Too much to count 
                 Too much 
                 29 colonies 
                 No Colony 
               
               
                   
                   
                 to count 
               
               
                 2.0% 
                 No Colony 
                 No Colony 
                 No Colony 
                 No Colony 
               
               
                 10.0%  
                 No Colony 
                 No Colony 
                 No Colony 
                 No Colony 
               
               
                   
               
               
                 Note: 
               
               
                 No Colony means total elimination of bacteria. 
               
             
          
         
       
     
         [0038]    For anti-virus testing, Bacteriophage T1, which infects  Escherichia coli  B, was adversely affected by P Compound. The percent loss of titer, due to the addition of P Compound, was observed for the phage after ten minutes of intermittent mixing at room temperature. After one hour (without mixing), T1 was totally inactivated. 
         [0039]    Further research is also warranted in testing P Compound as a nutraceutical or as a raw material that may have widespread implications in the treatment of potentially pathogenic microorganisms. 
         [0040]    All ingredients contained in P Compound are naturally derived and generally recognized as safe based on the Food &amp; Drug Administration and FEMA GRAS LISTS. P Compound ingredients can be added into hand sanitizers, soaps, baby wipes, moist towelettes, etc. 
         [0041]    Although the invented P Compound and the method of using same according to the present invention has been described in the foregoing specification with considerable details, it is to be understood that modifications may be made to the invention which do not exceed the scope of the invention claims and modified forms of the present invention done by others skilled in the art to which the invention pertains will be considered infringements of this invention when those modified forms fall within the claimed scope of this invention.