Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from zingiberaceae
Reexamination Certificate
2001-07-12
2002-11-26
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from zingiberaceae
C424S439000, C424S452000, C424S465000, C424S469000, C424S492000, C424S725000
Reexamination Certificate
active
06485759
ABSTRACT:
FIELD OF THE INVENTION
This invention pertains to herbal extracts, formulations and method for preparing the botanical combinations which can be used for treating AIDS and immune-deficient patients to maintain Kamofsky performance status greater than or equal to 90.
DESCRIPTION OF THE BACKGROUND ART
The currently accepted theory of Acquired Immune Deficiency Syndrome (AIDS) involves the loss of the helper cells of the immune system due to infection with the Human Immunedeficiency Virus (HIV). In the advanced stages of the disease, the immune system is rendered helpless in resisting even the normal bacterial flora encountered every day. Eventually, the patient is overcome by bacterial, fungal and viral infections and dies as a result of these opportunistic infections.
Considerable research, therefore, has been aimed at developing synthetic drugs that inhibit one or more stages of the viral life cycle of HIV. Limited success has been achieved by inhibiting the virus-coded reverse transcriptase and protease enzymes. However, a cure for AIDS has not yet been found, and therapy using the nucleoside analogs, although is used currently, has been limited due to many toxic side effects.
While many of the presently synthetic drugs inhibit one or more stages of the viral life cycle of viruses, only a few agents have had any practical value as stated in many pharmacopoeia and textbooks that the specific therapy for viral infections are generally unsatisfactory and thus treatment is primarily symptomatic. Moreover, many of these synthetic drugs show serious systemic adverse effects on various tissues to deteriorate the health even of a normal person. This is also the main reason why a large number of patients currently turn to traditional drugs where the partially purified drug contains mixture of ingredients helps not only suppressing certain pathogenic agents but also promote the well-being of a person that the appetite and body weight are in well-balance. This advantages of traditional drugs are presently realized world-wide and have now been proofed and used clinically especially in Europe, China and many other countries even the real mechanism of action can not yet be delineated.
Thus, there has been a revival in the use of traditional medicine to treat modern disease worldwide. The major source of traditional medicine is in developing countries in which large portions of the populations still rely heavily on indigenous traditional practitioners and local medicinal plants for satisfying their primary health care needs which is, in general, quite self-sufficient. Remedies making use of crude plant materials or their extracts have been handed down through many generations and kept largely secret by traditional practitioners. Continuing efforts to document these formulations are necessary to preserve this information which presently revealed invaluable. Attempts have also been made to improve the formula to give the best therapeutic results.
Herbal remedies have three main advantages over modern synthetic drugs. The first is that their long term use already establishes a certain degree of safety and efficacy in the use of the plant material for human consumption. The second advantage arises out of the use of crude plant materials, which are less costly to prepare than the isolated or synthetic medicinal compounds. In these crude plant materials with many natural components, several compounds in the plant very often act synergistically to increase the effectiveness of the crude plant preparation compared to isolated compounds. The third advantage of the use of medicinal plants is a reduced incidence of adverse drug reactions common to most therapies utilizing synthetic drugs.
The present invention describes formulation and process of making botanical compositions for maintaining Karnofsky score (KS) of 90-100 in immune-deficient patients and especially in AIDS patients. The formulated composition helps maintaining Kamofsky Score (KS) or Kamofsky Performance Scale ranges 90-100 of AIDS patients (vs 100 as of a normal person) with a mean CD4 count of 420 over a 100-week period with slight increase in body weight, where some patients even gain weight significantly. A follow-up result at 100 weeks after treatment using botanical combinations of the present invention shows that all patients are free of opportunistic infections, without undesirable adverse effects and new AIDS-defining event including no developing AIDS dementia complex or other cerebral events and can live a normal life. This is due to the fact that some of the herbal components possesses anti-infectious activity while some has appetite stimulatory effect. These botanical combinations help maintaining Kamofsky score (KS) of 90-100 in all AIDS patients being on the regimen over a 100-week non-comparative clinical trial period although the CD4 count has been shown to increase in only some patients (11 out of 25). This is in great contrast to those patients using didanosine 375 or 250 mg twice daily (for patients weighing <60 kg, n=279) and zidovudine 12 mg/kg/day (n=275) where 73% of patients in each group had experienced a new AIDS-defining event and 40% of patients in each group had died after 80 weeks of treatment (Perry and Noble, 1999). In addition, the cost of the presently described regimen is considerable inexpensive and affordable by the patients. These are contrary to those AIDS patients on very expensive modem regimens whose serious toxic side effects especially bone marrow suppression, abdominal pain, pancreatitis and peripheral neuropathy or lactic acidosis with hepatic steatosis are often the main cause of patient mortality (30-50% ) within a year after starting the therapy despite the fact that reduction in HIV viral load and plasma HIV RNA level have been reported.
BRIEF SUMMARY OF THE INVENTION
Botanical Combination therapies for maintaining Kamofsky score (KS) of 90-100 in AIDS and immune-deficient patients include therapeutic doses of five medicinal plants of Thailand. The first combination drug, ayurvedic composition 1, consists of spray-dried aqueous or aqueous organic solvent extracts of the plant materials
Houttuynia cordata, Combretum quadrangulare, Mimusops elengi, Randia siamensis
, and
Borassus flabellifer
in varied amounts 10-300 mg, 10-100 mg, 10-100 mg, 10-100 mg, and 60-600 mg, respectively. The drug mixture is administered in the form of one capsule (100-1,200 mg) twice daily. The second combination therapy consists of ayurvedic composition 1 (one capsule twice daily) plus one 10-500 mg capsule of ayurvedic composition 2 twice daily, where ayurvedic composition 2 is lyophilized or spray-dried powder of aqueous or aqueous organic solvent extract of plant
Houttuynia cordata
10-500 mg. Ayurvedic composition 3 consists of dried aqueous or aqueous organic solvent extracts of the plant materials
Houttuynia cordata, Combretum quadrangulare, Mimusops elengi, Randia siamensis
, and
Borassus flabellifer
in fixed amounts 32 mg, 20 mg, 20 mg, 20 mg, and 400 mg, respectively. Ayurvedic composition 4 is lyophilized or spray-dried powder of aqueous or aqueous organic solvent extract of plant material
Houttuynia cordata
in fixed amount, 100 mg. A process for preparing the botanical combinations includes washing, drying and grinding plant materials into powder, extracting the powder by boiling in water, filtering, spray-drying the extract and mixing the dried extracts in defined amount. The process also includes preparing the pharmaceutical dosage forms of the plant extract mixture as hard gelatin capsule which is stored in air-tight containers protected from light and as syrup or tablet or the like.
DETAILED DESCRIPTION OF THE INVENTION
The therapy presented here for maintaining Kamofsky score (KS) of 90-100 in AIDS and immune-deficient patients makes use of the combinations of botanical drugs. As Kamofsky Score (KS) or Kamofsky Performance Scale is currently accepted to be used in assessment protocols for evaluating an effect of herbal remedy in clinical management of the HIV/AIDS pat
Chantara Kim
Kraisintu Krisana
Jesadanont S.
Lilling Herbert J.
The Government Pharmaceutical Organization Research and Developm
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