Patent Publication Number: US-5834000-A

Title: Antiviral and antimicrobial herbal complex

Description:
BACKGROUND AND SUMMARY OF THE INVENTION 
     Colds and influenza are major causes of illness and loss of productivity throughout the United States and the rest of the world. For example the National Center for Health Statistics estimates that in 1992 62 million cases of the common cold in the United States required medical attention, and that colds caused 157 million days of restricted activity and 15 million days lost from work. Approximately 10-15% of adult colds are caused by viruses also responsible for other serious illnesses, including influenza A &amp; B viruses. It has long been considered desirable to provide an effective treatment for a wide variety of illnesses caused by viruses and bacterium, that are potent antiviral and antimicrobial agents, but also can relieve symptoms. Some traditional Chinese medicine herbal formulas can be at least somewhat effective in this regard, but they typically contain caffeine, chlorohydrate, or other components undesirable to a large segment of the population. It is desirable to provide effective herbal compositions without caffeine or other stimulants, and without chlorohydrate or like compositions. 
     According to the present invention a pharmacologically effective composition which is a broad spectrum antiviral and antimicrobial is provided which is completely herbal in nature and does not contain caffeine, chlorohydrate, or like undesirable components. Isatis leaf and root are the major ingredients, comprising collectively a majority of the composition. The composition may be used in the treatment of colds, infections, mumps, hepatovirus, chronic fatigue, influenza, sinus infections, stomach infections, blocked ears due to infection, bronchitis, genital herpes, and herpes simplex. The compositions according to the present invention are antiviral, antibacterial, and symptom relieving. 
     According to one aspect of the present invention a pharmacologically effective composition is provided comprising as the active ingredients: a mixture of Isatides tinctoria radix, Isatides tinctoria folium, Pueraria lobata radix, Forsythia suspensa fructus, Lonicera japonica flos and Chrysanthemem indici flos, in a pharmacologically effective amount. The components of the mixture preferably have the following contributions expressed in approximate weight percent: 
     Isatides tinctoria radix 32.5-42.5% (e.g. about 37.5%) 
     Isatides tinctoria folium 32.5-42.5% (e.g. about 37.5%) 
     Pueraria lobata radix 8-12% (e.g. about 10%) 
     Forsythia suspensa fructus 3-7% (e.g. about 5%) 
     Lonicera japonica flos 3-7% (e.g. about 5%) 
     Chrysanthemem indici flos 3-7% (e.g. about 5%). 
     Preferably the composition active ingredients consist essentially of the herbs set forth above. 
     The invention also relates to a method of substantially eliminating or ameliorating viral and microbial illness of human patients comprising the step of administering to a human patient in need of treatment an effective amount of a pharmacological composition such as set forth above. The invention also relates to a method of substantially eliminating or ameliorating in a human patient colds, flu, sinus infections, stomach infections, blocked ears due to infection, bronchitis, genital herpes, and herpes simplex, comprising the step of administering to a human patient in need of treatment an effective amount of a pharmacological composition as set forth above. 
     The invention also relates to a method of substantially eliminating or ameliorating viral and microbial illness of human patients comprising the step of administering to a human patient a pharmacologically effective composition comprising active ingredients consisting essentially of Isatis leaf and root making up the majority of the active ingredients, along with other anti-microbial herbal agents, and herbal agents for relief of aches and pains, sore throat, and to reduce fever. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     The identification of specific herbal complexes that will perform effectively pharmacologically without severe side effects is a painstaking and time consuming endeavor both in the initial development of the formulation, and in its subsequent testing. Traditional Chinese medicine includes a number of formulas that can be effective for the treatment of certain illnesses, however those formulas do not necessarily transfer over to other populations with the same effectiveness, and oftentimes can contain undesirable components (such as caffeine and chlorohydrate) for a large portion of the population. 
     According to the present invention a broad spectrum antiviral and antimicrobial herbal composition is provided which has been found to be effective in the treatment of Western population and it does not contain undesirable ingredients such as caffeine and chlorohydrate. The compositions according to the present invention use Isatis leaf and root as the major ingredients. These herbs have been used in traditional Chinese medicine for colds, virus, infection, cancer, mumps, hepatovirus, and chronic fatigue. These components are utilized in the composition according to the present invention along with other potent herbal antimicrobial agents, and along with herbs for relief of aches and pains, and sore throat, and to reduce fevers. The herbal compositions according to the present invention are antiviral, antibacterial, and symptom relieving. 
     According to the present invention a pharmacologically effective composition is provided comprising as active ingredients a mixture of Isatides tinctoria radix, Isatides tinctoria folium, Pueraria lobata radix, Forsythia suspensa fructus, Lonicera japonica flos and Chrysanthemem indici flos, in a pharmacologically effective amount. The components of the mixture preferably have the following contributions expressed in approximate weight percent: 
     
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Isatides tinctoria radix                                                  
                 32.5-42.5% (e.g. about 37.5%)                            
Isatides tinctoria folium                                                 
                 32.5-42.5% (e.g. about 37.5%)                            
Pueraria lobata radix                                                     
                 8-12% (e.g. about 10%)                                   
Forsythia suspensa fructus                                                
                 3-7% (e.g. about 5%)                                     
Lonicera japonica flos                                                    
                 3-7% (e.g. about 5%)                                     
Chrysanthemem indici flos                                                 
                 3-7% (e.g. about 5%).                                    
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     &#34;Isatides tinctoria radix&#34; is also known as indigo, or cruciferae, or Radix Isatidis, whereas &#34;Isatides tinctoria folium&#34; is also known as indigo, cruciferae, and folium Isatides. Active ingredients are believed to be indirubin, sinigrin, indical, indoxyl, isatan, and labenzyme. 
     &#34;Pueraria lobata radix&#34; is also known as Pueraria, leguminosae, radix puerariae, and by the common name &#34;kudzu&#34;. Active ingredients are believed to be daidzin, daizein, and puerarin. In the composition according to the invention it relieves fever, congestion, and other symptoms, without undesirable side effects. 
     &#34;Forsythia suspensa fructus&#34; comprises halfshells of the fruit of forsythia, also known as fructose forsythiae, and Oleaceae. Active constituents are believed to be phillyrin and other saponin and flavonol glycosides. In the composition of the invention it relieves the symptoms of sore throat and reduces fever without undesirable side effects. 
     &#34;Lonicera japonica flos&#34; comprises the whole flower buds of Lonicera, also known as Flos Lonicerae, and Caprifolaceae. Active ingredients are believed to be luteolin glucoside, lonicerin, and inositol. This herb is a potent anti-microbial and also relieves the symptoms of sore throat, and can reduce fever. 
     &#34;Chrysanthemem indici flos&#34; is also known as the whole flowers of chrysanthemum, or Flos Chrysanthemi, or Compositae. Active constituents are believed to be apigenin, borneol, and a variety of paraffins. In the compositions according to the invention this herbal agent soothes a number of aches, pains, and other symptoms of colds, flu, and the like, without side effects. 
     In addition to the active ingredients, the herbal complexes utilized according to the present invention may have any number of substantially inert ingredients which will vary depending upon the particular form by which the complex will be administered. Normally the complex is administered in the form of ingestible tablets or capsules which are swallowed with water, although the complex active ingredients may be mixed with food or beverage items and eaten or drunk, or in extreme cases may be introduced directly into the bloodstream using a hypodermic needle, I.V., or the like. The dose may vary depending upon the size, age, and condition of the patient being treated and the particular percentages of components herbal complex utilized, but normally between about 500-3000 mg of active herbal complex is administered per day, with part of the total dose preferably taken at two or more different times during the day. 
     A typical manner of processing herbs to produce the complex may be as follows, although a wide variety of different known processing techniques may be utilized depending upon the exact form of the material desired, and the availability of material or equipment: 
     The powder end product of the complex is typically a 1:1 extract. Testing of raw materials used is conducted using standard organoleptic, High performance Liquid Chromatography, and microbiologic methods. The solvent mixture used for extractions for herbs used in the complex is about 95% SDA-3C and about 5% potable water. SDA-3C is specifically denatured alcohol composed of 95% ethanol and 5% isopropyl. The extraction method is thermokinetic maceration, specifically about 180° F. for about three hours, plus warm up and cool down. 
     Following extraction, a sample is tested for the percentage of dissolved solids recovered. This is compared with the specified standards and, when necessary, the processing is continued until the standards are reached. The base material of the extract is marc; no rinse of the extracted powder is required. The miscella is distilled. The distilled total miscella is dehydrated onto the base material. This receives a final milling (1/32&#34; screen) in a sanitary stainless mill, using a vacuum system to transport the product directly into the final containers. Samples are taken for quality control tests which are visual, taste, microbiologic and High Performance Liquid chromatography. Samples are also taken for permanent record. That material is readily made into tablets, or placed in ingestible capsules, e.g. about 300 mg per capsule. 
     Another possible technique is as follows: 
     The powder and end product of this formula is typically a 1:1 extract. Testing of raw materials used is conducted using standard organoleptic, High Performance Liquid Chromatography and microbiologic methods. The solvent solution is preferably about 95% SDA-3C and 5% water. 
     The herb and the solvent are added together in the extract processor for processing. The supernatant liquid of solvent and solids is drained into the holding/settling tank where the volume is measured and the solids content is determined by analysis. Samples are drawn of both and liquid supernatant and sediment for microbiologic testing. The supernatant liquid is pumped through a 100 mesh liquid filter into the Sanitizing vessel. The liquid is processed for a minimum of four hours at the boiling temperature of about 178° F. The volume of the liquid is measured and a solids analysis is done. A sample is drawn for microbiologic testing. The liquid is pumped through a 100 mesh filter and sprayed into the vacuum dryer, using volume and solids data to adjust the product to the desired concentration for the finished product. The resulting material is dried. The processor is emptied into sanitary bulk bins or barrels and transported to milling. A pre-grind sample is drawn for biologic testing. The material is milled in a sanitary stainless steel milling system using a 1/16&#34; screen. The material is unloaded from the mill system directly via Vac-u-Max collector into double lined 44 gallon fiber drums. A sample is drawn from each container for biologic testing. Typical microbiologic requirements are: 
     
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                    Limits                                                
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Aerobes             max. 10,000/g                                         
Coliform            negative                                              
Salmonella          negative                                              
E. Coli             negative                                              
Yeast               max. 100/g                                            
Mold                max. 100/g                                            
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     The utilization of complex herbal formulations as set forth above for the elimination or amelioration of a number of viral or bacteria related illnesses, such as colds, flu, sinus infections, stomach infections, blocked ears due to infections, bronchitis, genital herpes, and herpes simplex, has been shown to be effective through testing. A pharmacologically effective composition comprising as active ingredients a mixture having the following contributions expressed in weight percent: 
     
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Isatides tinctoria radix                                                  
                       about 37.5%                                        
Isatides tinctoria folium                                                 
                       about 37.5%                                        
Pueraria lobata radix  about 10%                                          
Forsythia suspensa fructus                                                
                       about 5%                                           
Lonicera japonica flos about 5%                                           
Chrysanthemem indici flos                                                 
                       about 5%,                                          
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     has been tested as indicated by the following table (each capsule contained about 300 mg active ingredients): 
     
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Clinical Data Table                                                       
   Patient Age    Treatment                                               
                       Presenting                                         
Log #                                                                     
   &amp; Gender                                                               
         Dosage Time                                                      
                  Duration                                                
                       Symptoms                                           
                              Resultant Effects                           
                                      Side Effects                        
__________________________________________________________________________
304                                                                       
   54 yrs                                                                 
         1 capsule 3 × daily                                        
                  10 days                                                 
                       stomach &#34;flu&#34;                                      
                              stomach much                                
                                      none                                
   female                     improved                                    
305                                                                       
   late 50s                                                               
         1 capsule 3 × daily                                        
                  3 weeks                                                 
                       bacterial                                          
                              &#34;it is the only                             
                                      none                                
   male                infection in his                                   
                              medication that                             
                       stomach                                            
                              worked on his                               
                              stomach                                     
                              problem&#34;                                    
306                                                                       
   mid 30s                                                                
         3 capsules 3 ×                                             
                  5 days                                                  
                       residual ear                                       
                              his ears                                    
                                      none                                
   male  daily         blockage after                                     
                              completely                                  
                       the flu                                            
                              cleared up                                  
308                                                                       
   49 years                                                               
         2 capsules 3 ×                                             
                  1 week                                                  
                       chronic                                            
                              bronchitis cleared                          
                                      none                                
   male  daily         bronchitis since                                   
                              up                                          
                       1973                                               
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     In the above table, each capsule contained approximately 300 mg of the herbal complex. The herbal formulations according to the invention are effective when administered alone, but can be administered with other pharmacological treatments typically without adverse side effects. 
     It is highly desirable that the herbal compositions according to the present invention consist essentially of herbal agents, and do not have undesirable materials such as those that are primarily stimulants, depressants, or the like, as active ingredients (and that any &#34;inert&#34; ingredients added also do not include undesirable materials such as depressants or stimulants). Particularly to be avoided are stimulants such as caffeine, and chlorohydrate or like materials. 
     Thus it will be seen that according to the present invention broad spectrum antiviral and antimicrobial herbal complexes are provided which are effective but which have few or no side effects, and do not require stimulants or other undesirable ingredients to be effective. While the invention has been herein shown and described in what is presently conceived to be the most practical and preferred embodiment thereof it will be apparent to those of ordinary skill in the art that many modifications may be made thereof within the scope of the invention, which scope is to be accorded the broadest interpretation of the appended claims so as to encompass all equivalent methods and products.