Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2002-07-31
2004-02-24
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S728000, C424S773000, C424S777000, C424S551000, C424S553000
Reexamination Certificate
active
06696094
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a novel herbal pharmaceutical composition and its use for treating patients with human immunodeficiency virus (HIV) infection. The pharmaceutical composition is in the form of an intravenous injection solution or capsules and contains aqueous extracts of fourteen (14) herbal ingredients, including diffuse hedyotis, bistort rhizome, giant knotweed rhizome, Chinese magnoliavine fruit, Asiatic moonseed rhizome, baical skullcap root, bovine biliary powder, tumeric root-tuber, hawthorn fruit, sanqi, barbary wolfberry fruit, figwort root, Chinese angelica, and milkvetch root. The intravenous injection solution can be administered alone or co-administered with the capsules. The present invention also includes the methods for making the pharmaceutical composition and for treating the patients with HIV infection.
DESCRIPTION OF THE RELATED ART
The present invention is a continuation-in-part (CIP) of the parent patent application, U.S. patent application Ser. No. 09/906,791, now U.S. Pat. No. 6,455,078, which is herein incorporated by reference. In the parent application, novel pharmaceutical compositions, which are particularly effective in treating patients with human immunodeficeincy virus (HIV), were described.
HIV infection causes acquired immunodeficiency syndromes (AIDS) in humans which presents special problems to the medical community. AIDS is a pandemic immunosuppressive disease which results in life-threatening opportunistic infections and malignancies. The retrovirus, HIV, has been isolated and identified as the etiologic agent of this disease. HIV has been detected in whole blood, plasma, lymphatic fluid, serum, semen, vagina fluid, breast milk, tears, saliva, and central nervous system tissue of infected patients. HIV can be transmitted through sexual contact with an infected person, by sharing needles or syringes (primarily for drug injection) with an infected person, or, less commonly, through transfusions of infected blood or blood clotting factors. Babies born to HIV-infected women may become infected before or during birth or through breast-feeding after birth. As of this time, complete cure for HIV infection/AIDS has been diligently pursued by scientists around the world, yet there has been no report of absolute success.
Pharmaceutical compositions made from natural herbs have been known and used for thousands of years to cure or ameliorate various diseases and injuries. Some of these herbal compositions have been disclosed for having medicinal properties for curing or ameliorating symptoms associated with HIV infection. For example, U.S. Pat. No. 5,178,865 discloses screening of fifty-six (56) individual herbs and have found that ten (10) out of 56 herbs exhibits anti-HIV activity in ex vivo experiments. The ten (10) individual herbs include
Coptis chineusis, Ligusticum wallichii, Illicium lanceolatum, Isatis tinctoria, Salvia miltiorrhiza, Erycibe obtusifolia, Acanthopanax graciliatylus, Bostaurus domesticus, Inula helenium
, and
Lonicera japonica
. Both
Bostaurus domesticus
and
Lonicera japonica
are further described to be able to combine with
Scutellaria baicaleusis
to exhibit anti-HIV activity.
U.S. Pat. No. 5,837,257 discloses Chinese herbal medicines that exhibit in vitro antiviral activities against murine leukemia virus and HIV and for treatment of animals and humans infected with HIV. In one of the preferred embodiments, the Chinese herbal medicines contain hedyotis, scutellariae barbatae herba, lonicerae flos, prunellae spica, and solani herba.
U.S. Pat. No. 5,989,556 discloses various herbal compositions for treating viral infection. One of the herbal compositions contains Aeginetiae Herba, Blechni Rhizoma, Lespedezae Herba, Polygoni Cuspidati Rhizoma, Forsythiae Fructus, and Ligustri Fructus. Another herbal composition contains Cirsii Rhizoma et Radix, Breeae Radix, Baphicacanthis Rhizoma et Radix, Phellodendri Cortex, and Bletillae Tuber. A third herbal composition disclosed in the patent has Aeginetiae Herba, Lonicerae Flos, Prunellae Spica, and Lespedezae Herba.
The present invention provides a novel pharmaceutical composition for treatment of HIV, both in vitro and in vivo, including treatment of AIDS patients, which are distinctively different from prior art disclosures. This novel pharmaceutical composition differs from the pharmaceutical compositions described in the parent application for not containing red ginseng (Radix
ginseng rubra
). The pharmaceutical composition of the present invention is a natural Chinese medicine with little or no side effects and has no toxicity.
SUMMARY OF THE INVENTION
The present invention provides a pharmaceutical composition which is particularly effective in treating HIV-positive or AIDS patients. The pharmaceutical composition (in the name of “HIVCIDE”) is in the form of an injection solution (for intravenous injection) or capsules. It contains aqueous extract of the following herbal ingredients: (1) an entire plant of Herba
Hedyotidis diffusae
(diffuse hedyotis); (2) a rhizome of Rhizoma Bistortae (bistort rhizome); (3) a rhizome of Rhizoma
Polygoni Cuspidati
(giant knotweed rhizome); (4) a ripe fruit of Fructus Schisandrae (Chinese magnoliavine fruit); (5) a rhizome of Rhizoma Menispermi (Asiatic moonseed rhizome); (6) a root of Radix Scutellariae (baical skullcap root); (7) bovine biliary powder; (8) a root tuber of Radix Curcumae (tumeric root-tuber); (9) a ripe fruit of Fructus Crataegi (hawthorn fruit); (10) a root of Radix Notoginseng (sanqi); (11) a ripe fruit of Fructus Lycii (barbary wolfberry fruit); (12) a root of Radix Scrophulariae (figwort root); (13) a root of Radix
Angelicae sinensis
(Chinese angelica); and (14) a root of Radix Astragali (milkvetch root). Examples of the aqueous solution for extracting the pharmaceutical ingredients from the herbs include, but are not limited to, water, ethanol, or a mixture thereof. The preferred aqueous solution is water.
The herbal ingredients of HIVCIDE differ from that in the parent application by not containing the root of Radix
ginseng rubra
(red ginseng). Also, the weight ratio of the pharmaceutical composition of the present invention is different from that of the pharmaceutical composition of the parent application by containing more quantity of diffuse hedyotis. The weight ratio of the 14 ingredients listed above is about 4:3:1:2:1:1:0.1:1:2:1:3:2:1:2.
The aqueous extract of the herbal ingredients is further filtered and condensed. The condensed aqueous extract is called “herbal condensate” or “HIVCIDE condensate.”The volume of the herbal filtrate is about 1.4 fold of the herbal condensate.
The gram weight of the HIVCIDE for the purpose of determining the dosage amounts for patient treatment as described hereinafter is based on the weight of the “HIVCIDE condensate,” not the weight of the original herbal ingredients.
The present invention also includes a method for preparing HIVCIDE which includes the steps of: (1) grinding and mixing diffuse hedyotis, bistort rhizome, giant knotweed rhizome, Chinese magnoliavine fruit, Asiatic moonseed rhizome, baical skullcap root, bovine biliary powder, tumeric root-tuber, hawthorn fruit, sanqi, barbary wolfberry fruit, figwort root, Chinese angelica, and milkvetch root to form a herbal mixture; (2) boiling the herbal mixture in water to form a water extract; (3) filtering the water extract to collect an herbal filtrate; and (4) concentrating the herbal filtrate to form an herbal condensate (also known as “HIVCIDE condensate”). The HIVCIDE condensate is then either dissolved in a suitable solution to form the intravenous injection solution or sprayed dried to form herbal powders. The herbal powders are further mixed with a binder, such as starch, and encapsulated.
The HIVCIDE injection solution contains about 0.1-1 g of the HIVCIDE condensate per ml of the injection solution. When administering to patients, the HIVCIDE is perferably diluted to about 1:5 to 1:10 by volume of 5% glucose solution.
The present invention further contains a method
Chao Fei-Fei
Tate Christopher R.
Venable LLP
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