Patent Publication Number: US-5529778-A

Title: Ayurvedic composition for the prophylaxis and treatment of AIDS, flu, TB and other immuno-deficiencies and the process for preparing the same

Description:
This invention relates to ayurvedic composition for the prophylaxis and treatment of AIDS, FLU, TB as also viral, bacterial and parasitical diseases and other immunodeficiency conditions and the process for preparing the same. 
     BACKGROUND 
     AIDS is the biggest challenge to medical sciences during this century. It is said to be caused by the virus HIV (Human Immuno-deficiency Virus), which kills the helper cells of the immune system. These cells which are a part of the cell mediated immune system, play a crucial role in cell mediated immunity. With the progressive loss of the helper cells in the blood, a stage is reached where the body is rendered incapable of resisting many bacterial, viral and parasitical invasions and the AIDS patient eventually dies of these opportunistic infections. Many people have lost their lives from this disease which is wide spread throughout the world. 
     Scientists of the world have launched a massive research programme to develop a drug for the treatment of AIDS which has been in progress for over ten years. The approach has been to interfere with the life cycle of the HIV. The only drug approved for treatment of AIDS in different stages is zidovudine (AZT). However, it has not been found to be effective in curing a patient or saving the life of an advance case of AIDS. Recently, a joint study of British and French groups on thousands of cases in U.K. and France, titled Concord has shown the ineffectiveness of the drug AZT in controlling the progression or cure of AIDS. 
     A new approach has been developed which is based on enhancing cell mediated and humoral immunity by selected Ayurvedic drugs of herbal origin and simultaneously stimulating the physiological functions of the body for the treatment of AIDS. With the correction of immuno-deficiency, the body&#39;s own defensive forces selectively kill all the infecting organisms and the syndrome of AIDS disappears. An additional advantage of our new approach is the absence of adverse drug reactions which usually accompany therapies developed so far in the West. 
     The drug used in our new approach for the treatment of AIDS consists of two multi-component drugs of ayurvedic origin called LIVZON and IMMINEX in predetermined proportions. 
     According to this invention ayurvedic compositions for the prophylaxis and treatment of AIDS, FLU, TB and other Immuno-deficiency conditions, liver diseases such as hepatitis and cirrhosis etc. which comprises: 
     (i) LIVZON consisting of: 
     
         ______________________________________                                    
Phyllanthus niruri   292-310 mg.                                          
Tinospora cordifolia 190-210 mg.                                          
Phyllanthus emblica  90-110 mg.                                           
Terminalia belerica  90-110 mg.                                           
Terminalia chebula   290-310 mg.                                          
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     and 
     (ii) IMMINEX consisting of: 
     
         ______________________________________                                    
Holarrhena antidysenterica                                                
                      40-60 mg.                                           
Picrorhiza kurrooa    40-60 mg.                                           
Swertia chirata       15-35 mg.                                           
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     The total weight of extracts of Tinospora cordifolia, Phyllanthus emblica, Terminalia belerica and Terminalia chebula in LIVZON varies between 190-210 mgs. 
     This invention further relates to process for preparing the said ayurvedic composition for prophylaxis and treatment of AIDS, FLU, TB and other immunodeficiencies which comprises: 
     pulverising: 
     (i) LIVZON consisting of: 
     
         ______________________________________                                    
Phyllanthus niruri   292-310 mg.                                          
Tinospora cordifolia 190-210 mg.                                          
Phyllanthus emblica  90-110 mg.                                           
Terminalia belerica  90-110 mg.                                           
Terminalia chebula   290-310 mg.                                          
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     and 
     (ii) IMMINEX consisting of: 
     
         ______________________________________                                    
Holarrhena antidysenterica                                                
                      40-60 mg.                                           
Picrorhiza kurrooa    40-60 mg.                                           
Swertia chirata       15-35 mg.                                           
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     preparing extracts or isolates thereof. 
     mixing the said extracts or isolates and preparing in pharmaceutical dosage form. 
     The total weight of extracts of Tinospora cordifolia, Phyllanthus emblica, Terminalia belerica and Terminalia chebula in LIVZON varies between 190-210 mgs. 
     The pharmaceutical dosage is in the form of hard gelatin capsule or liquid form mixed with syrup in the following proportion: 
     LIVZON:Syrup::1:15 
     IMMINEX:Syrup::1:75 
     The pharmaceutical dosages in capsule form are stored in plastic or glass containers with silica gel bags sealed with aluminium foil. 
     DOSAGE 
     One capsule normally contains LIVZON consisting of Phyllanthus niruri--300 mg and extracts of Tinospora cordifolia, Phyllanthus emblica, Terminalia belerica and Terminalia chebula--200 mg and Imminex--125 mg and may be given twice daily. This dosage may vary. 
     The patients are tested for HIV by Elisa and the Western Blot technique to confirm the presence of HIV 1 or HIV 2. and the CD4 (helper cells) and CD8 (suppressor cell) counts and the CD4:CD8 ratio is estimated. 
     One dose each of the two drugs are administered twice a day after meals to confirmed cases of `full blown AIDS` or in the `Carrier stage`. After a period of 1 month, the CD4 count is estimated again and the treatment continued till the count rises about 1000 and above. Even after the CD4 count reaches the figure of 2000 or so, the treatment is continued till the patient becomes HIV negative. 
     For prophylaxis, the drugs are administered in the same schedule mentioned above to raise the CD4 count. A person having a CD4 count of about 2000 and a CD4:CD8 ratio of nearly 2, can resist casual exposure to HIV infection. The married partner of an HIV positive person can also be protected in this manner. 
     An HIV positive pregnant woman has to be given one dose twice daily in order to protect the foetus. Post natally if the child shows symptoms of AIDS and tested HIV positive, one dose of each drug twice daily in syrup form should be administered till the CD4 count reaches a level normal for the age of the child. The above therapy has to be continued till the mother and child are fully protected from opportunistic infectious as indicated by the CD4 count and CD4:CD8 ratio. 
     During the course of treatment, all conventional drugs having an immuno suppressive activity have to be excluded. 
     The dose schedule can be varied according to the advise of the physician. 
     During the course of treatment, all drugs possessing immuno-suppressive activity are contra-indicated and are excluded from the therapy. 
    
    
     EXAMPLE-1 
     The ayurvedic compositions for the treatment of AIDS and other immunodeficiencies is prepared by: 
     pulversing 
     (i) LIVZON consisting of: 
     
         ______________________________________                                    
Phyllanthus niruri     300 mg.                                            
Tinospora cordifolia   200 mg.                                            
Phyllanthus emblica    100 mg.                                            
Terminalia belerica    100 mg.                                            
Terminalia chebula     300 mg.                                            
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     and 
     (ii) IMMINEX consisting of: 
     
         ______________________________________                                    
Holarrhena antidysenterica                                                
                        50 mg.                                            
Picrorhiza kurrooa      50 mg.                                            
Swertia chirata         25 mg.                                            
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     preparing extracts or isolates thereof 
     mixing the said extracts or isolates in syrup or filling the said mixture in hard gelatin capsule at 15°-18° C. in pharmaceutical dosage form. 
     The total weight of extracts of Tinospora cordifolia, Phyllanthus emblica, Terminalia belerica and Terminalia chebula in LIVZON is 200 mg. 
     The above ingredients of LIVZON and IMMINEX are cleaned, washed, dried and separated of all extraneous matter and then powdered and extracted with distilled water, the said extracts are concentrated, granulated and dried at low temperatures before mixing to form one pharmaceutical dosage. 
     EXAMPLE-2 
     The ayurvedic composition for the treatment of AIDS and other immunodeficiencies comprising 
     (i) LIVZON consisting of: 
     
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Phyllanthus niruri     300 mg.                                            
Tinospora cordifolia   200 mg.                                            
Phyllanthus emblica    100 mg.                                            
Terminalia belerica    100 mg.                                            
Terminalia chebula     300 mg.                                            
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     and 
     (ii) IMMINEX consisting of: 
     
         ______________________________________                                    
Holarrhena antidysenterica                                                
                        50 mg.                                            
Picrorhiza kurrooa      50 mg.                                            
Swertia chirata         25 mg.                                            
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     as extracts or isolates thereof. 
     The total weight of extracts of Tinospora cordifolia, Phyllanthus emblica, Terminalia belerica and Terminalia chebula in LIVZON is 200 mg. 
     The aforesaid ingredients are cleaned, washed and separated of all extraneous matter and then powdered and extracted with distilled water individually before mixing. The extracts so obtained were concentrated and then absorbed on inert plant material, granulated and dried at low temperatures. The above mixture of LIVZON and IMMINEX is filled in a hard gelatine capsule at 15° C.-18° C., the filled capsules are kept in plastic containers with silica gel bags sealed with aluminium foils for use. 
     EXAMPLE 3 
     Aqueous extracts of the above ingredients viz. Livzon and imminex are concentrated and mixed with syrup and filled in bottles in the following proportion: 
     LIVZON:syrup::1:15 
     IMMINEX:Syrup::1:75