Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-07-18
2002-09-24
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S728000, C424S773000, C424S777000, C424S551000, C514S893000, C514S894000
Reexamination Certificate
active
06455078
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a novel herbal pharmaceutical composition and its use for treating patients with liver diseases (e.g., viral hepatitis [such as Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis D, and Hepatitis E], alcoholic or fatty liver, liver cirrhosis, and liver cancer) and HIV. The major ingredients in the herbal composition are diffuse hedyotis, bistort rhizome, giant knotweed rhizome, and Chinese magnoliavine fruit. The composition further contains Asiatic moonseed rhizome, baical skullcap root, bovine biliary powder, tumeric root-tuber, hawthorn fruit, sanqi, barbary wolfberry fruit, red ginseng, figwort root, Chinese angelica, and milkvetch root. The present invention also relates to a method for making the medicinal herbal composition and methods for treating patients with the medicinal herbal composition.
DESCRIPTION OF THE RELATED ART
Liver diseases have great impact on human health. Hepatitis is a kind of liver diseases, which is caused by liver inflammation due to infection of a variety of pathogens, which include, but are not limited to, viruses, bacteria, fungi, and protozoa. Hepatitis can be categorized as acute, chronic, or fulminant.
Viral hepatitis is an enterically transmitted liver disease due to viral infection. The major transmission means for viral hepatitis is through ingestion. Viral hepatitis can also be transmitted through blood transfusion or similar means of hepatitis-virus-carrying blood or blood product such as blood plasma. Viral hepatitis is widespread around the world. For example, there are approximately thirty million (30,000,000) viral hepatitis patients in China including an estimated number of nine million (9,000,000) new patients each year, and about one hundred million (100,000,000) hepatitis B virus (HBV) carriers. It is estimated that 10% of the pregnant women in China are HBV carriers. About one hundred thousand (100,000) people in China die of liver cancer originated as liver diseases each year.
Depending on the major etiologic agent, viral hepatitis is categorized into Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis D, and Hepatitis E. Hepatitis A is caused by hepatitis A virus (HAV); Hepatitis A can affect anyone and occur in isolated cases as well as widespread epidemics. Hepatitis B is a serious disease caused by hepatitis B virus (HBV). HBV attacks the liver and can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. Hepatitis C is caused by hepatitis C virus (HCV). Hepatitis D is caused by the hepatitis D virus (HDV) which is a defective single-stranded RNA virus that requires the helper function of HBV to replicate and to synthesize envelope protein composed of HBsAg to encapsulate HDV's genome. Hepatitis E is caused by hepatitis E virus (HEV), which is an etiologic agent of enterically transmitted non-A, non-B hepatitis. HEV is a spherical, non-enveloped, single-stranded RNA virus of approximately 32 to 34 nm in diameter. HEV has been provisionally classified in the Caliciviridae family; however, the organization of the HEV genome is substantially different from that of other Caliciviruses, and HEV may eventually be classified in a separate family.
The most common types of viral hepatitis are Hepatitis A, Hepatitis B, Hepatitis C, and Hepatitis E, which have similar major symptoms including decreased appetite, nausea, unease upper abdomen, lack of strength, etc. Acute jaundice is also one of the common symptoms. Chronic hepatitis is very difficult to cure. Severe hepatitis often comes on quickly and results in high mortality.
Traditional Chinese herbal compositions have been developed and shown success for preventing and treating various liver diseases. The types of traditional Chinese herbal medicine for treating hepatitis include medications having single or multiple herbal components and medications made of active ingredients extracted from the herbs.
For example, Qianglining injection solution is made of glycyrrhizic acid extracted from licorice (Glycyrrhiza). Glycyrrhizic acid reacts with ammonia to form a water-soluble ammonium salt of glycyrrhizic acid, which then can compound with amino acids. The injection solution is useful for treating chronic viral hepatitis, liver cirrhosis, and hepatoma. The total effective rate of qianglining injection solution is about 87.5%, in which 64.1% is significant, according to clinical studies conducted on hepatitis patients provided by Shanghai Huashan Hospital, Shanghai, China.
Yanhuanglian injection solution is derived from ground herb Yanhuanglian grown in Guangxi Province in China. The solution is useful for treating various types of hepatitis, liver cirrhosis, and liver cancer, with a reported clinical efficacy rate of 81.47%. The solution has an effective rate of 93.88% in cases involving acute jaundice patients, 87.50% in non-jaundice type hepatitis patients, 87.09% in chronic active type hepatitis patients, 69.23% in prolonged type hepatitis patients, and 80.95% in chronic cirrhosis patients. However, only 17.91% of the patients show changes of HBV surface antigen from positive to negative.
Shandougen (
Radix Sophorae Tonkinensis
) injection solution is useful for both acute and chronic viral hepatitis, and especially effective for chronic active hepatitis. As studied by Guangxi Medical College in Guangxi province, China, the total effective rate is 91.79% for chronic active hepatitis patients, and the substantial effective rate is 54.23%. Also, 64.93% of the patients' glutamate-pyruvate transaminase (GPT) level returns to normal in two (2) months after the treatment. However, some patients show recurring symptoms of hepatitis after the treatment is discontinued.
Umbellate pore fungus (
Polyporus umbellata
) injection solution has functions of improving immune function, inhibiting tumor, lowering level of transaminase, and inhibiting replication of hepatitis virus. After treating patients with chronic viral hepatitis with umbellate pore fungus injection solution, 35.6% of the patients return to normal serum GPT (SGPT) level, 76.61% of the patients show some lowering effects on transaminase level, 38.6% of the patients show HBV E antigen turning negative, and 13.1% of the patients show surface antigen turning negative.
Qidun fruit acid tablet has a total effective rate of 94.4% in patients with acute jaundice-type hepatitis. The total recovery rate is 64.8%. Qidun fruit acid tablet also shows an effective rate of 69.8% in chronic active hepatitis, in which 43.7% of the patients show a significant effect. The rate for HBsAg positive turning negative is 16.8%.
Gandezhi (Liver-curing) capsule has Wuren alcohol,
scutellarin
, mulberry fruit-spike (
Fructus Mori Albae
), salvia root (
Radix Salviae Miltiorrhizae
), and licorice (
Radix Glycyrrhizae Uralensis
) and is useful for lowering transaminase level. It has an effective rate of 80.0% for treating prolonged hepatitis and chronic hepatitis, according to studies reported by Guangzhou Zhongshan Medical College Hospital in China. There has been no report which shows that Gandzhi has effect on HBV Antigen turning negative.
Danggui (Chinese angelica root) pill is made of Chinese angelica root (
Radix Angelicae Sinensis
) and licorice (
Radix Glycyrrhizae Uralensis
). In a study conducted by Beijing Medical College in China, Danggui pill is effective for treating prolonged hepatitis (with an effective rate of 84.4%), chronic hepatitis (with an effective rate of 79.1%), and cirrhosis resulted from hepatitis (with an effective rate of 73.6%).
Hugang (liver-protecting) tablet is made from schisandra fruit (
Fructus Schisandrae Chinensis
) alcohol extractant, liver-protecting extractant (including Junchen, Zihu, and woad root (isatis root,
Radix Isatidis seu Baphicacanthi
)), and biliary powder, etc. It has an effective rate of 95.08% for treating chronic hepatitis (70% with significant effect), and 82.5% for treating cirrhosis (63% with significant effect).
Jigu (“chicken bone”) grass pill is made of Jigu grass, billiary p
Chao Fei-Fei
Tate Christopher R.
Venable Baetjer Howard & Civiletti LLP
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