Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-02-16
2004-04-27
Witz, Jean C. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S750000
Reexamination Certificate
active
06726938
ABSTRACT:
Throughout this application, various publications are referenced and full citations for these publications may be found in the references at the end of the specifications preceding the claims. The disclosures of these publications are hereby incorporated by reference into this application in order to more fully describe the state of the art as known to the skilled therein as of the date of the invention described and claimed herein.
BACKGROUND OF THE INVENTION
Fagopyrum cymosum
(Trev.) Meisn is a species of buckwheat, which belongs to the Genus Fagopyrum, family Polygonaceae. There are about 14 species of buckwheat, either cultivated or wild, existing around the world. Buckwheat grows mainly in the temperate area of Asia, Europe and North America. (1)
China was the earliest country in the world to cultivate buckwheat. According to archaeological studies, China began to grow buckwheat about 2,000 years ago. The genetic origins of buckwheat are believed to occur in Yunnan and Sichuan Provinces of China.(2) Buckwheat was brought from China to Japan via Korea Peninsula and then to Europe via Siberia and southern Russia. Germany was the first country in Europe to grow buckwheat in 1396. Then the crop was introduced into Belgium, France, Italy and Britain in the 17th century. Later buckwheat was brought to North America from the Netherlands.
At present, there are three best known species of buckwheat: common buckwheat (
Fagopyrum esculentum
), tartary buckwheat (
Fagopyrum tataricum
) and cymose buckwheat (
Fagopyrum cymosum
). The common buckwheat (
Fagopyrum esculentum
) is widely cultivated in the Northern Hemisphere. In China, it grows mainly in the northern and northwestern provinces. The tartary buckwheat (
Fagopyrum tataricum
) is cultivated primarily in the Himalayan area and south and southwest China. The cymose buckwheat (
Fagopyrum cymosum
) is basically a wild species, not available for human consumption as a crop, although some reports indicate that it is also cultivated in China on a small scale. The cymose buckwheat (
Fagopyrum cymosum
) distributes only in south and southwest China.
Although buckwheat is cultivated mainly as a minor crop around the world, it has been found recently that certain species of buckwheat also possess therapeutic properties. Animal tests and clinical trials in China have indicated that tartary buckwheat flour is effective in preventing and treating diabetes, hypertension, cerebral arteriosclerosis and cardiovascular disease. It also has the function of invigorating the stomach, facilitating digestion, enhancing the immune system and alleviating inflammation.(3)
The most important therapeutic property discovered in buckwheat is the anti-cancer effect of certain buckwheat species. For example, Samel, D. et al. reported in 1996 that they had examined the effect of a purified extract of the flowering herb of
Fagopyrum esculentum
on various protein kinases involved in signal transduction, finding that
Fagopyrum esculentum
contains red fluorescent compounds having photosensitizing properties. Spectrophotometric analysis of the extract indicated structural similarity to hypericin. Dose- and light-dependent inhibition of various protein kinases was observed. The purified
Fagopyrum esculentum
extract strongly inhibited two receptor-associated protein tyrosine kinases (EGF-R and Ins-R) and a Ser/Thr kinase (PK-C) at an ng/ml concentration range. Selectivity was exhibited as a decreased sensitivity to cytosolic PTKs and protein kinase CK-2. The protein kinases are important components of the signal transduction pathway. Aberration of signal transduction is a hallmark of several proliferative diseases. The researchers believed that the results of their experiment indicated that photosensitizing compounds in
Fagopyrum esculentum
are potential antiproliferative agents.(4)
In China, research on anti-cancer effect of buckwheat species was concentrated on
Fagopyrum cymosum
(Trev.) Meisn, which is also termed as
Fagopyrum dibotrys
(D. Don) Hara.
Fagopyrum cymosum
(Trev.) Meisn has been used as a herbal medicine in China since ancient times, but mainly in combination with other medicinal herbs. Modern clinical studies conducted in China have shown that preparations of
Fagopyrum cymosum
(Trev.) Meisn can be used to treat lung abscess, bacillary dysentery and pyogenic infections. (5) Most importantly it has been found that preparations of
Fagopyrum cymosum
(Trev.) Meisn can be applied effectively for therapeutic purposes to various kinds of tumors.
Liu, W F et al. published an article in 1981 on some pharmacological properties of
Fagopyrum cymosum
(Trev.) Meisn, the root of which had been used for the treatment of pulmonary abscess. Liu pointed out that major active principle of
Fagopyrum cymosum
(Trev.) Meisn is flavanol (5, 7, 3′, 4′-tetrahydroxyflan-3-01 dipolymers). Neither the extract of
Fagopyrum cymosum
(Trev.) Meisn nor flavanol exhibited significant antibacterial action in vitro. No antibacterial substance was found in the urine of either mice or human beings nor was it found in the organs of mice given the extract p. o. Liu indicated that therapeutic effect of
Fagopyrum cymosum
(Trev.) Meisn was shown in mice infected I. p. with
staphylococcus aureus
only when the extract of
Fagopyrum cymosum
(Trev.) Meisn or flavanol was given via the same route. Phagocytic action of peritoneal macrophages was enhanced, but the number of macrophages was not increased when the extract of
Fagopyrum cymosum
(Trev.) Meisn or flavanol was given I. p. to mice. Antipyretic action was demonstrated in rabbits. Flavanol was shown to be anti-inflammatory in mice and rats. Platelet aggregation in rats induced by ADP and
staphylococcus aureus
in vitro was inhibited by flavanol. The same effect on platelet aggregation induced by ADP and collagen was found when flavanol was given IV to rats. Flavanol given IV showed also expectorant effect in mice as shown by the phenol red method, but the bronchial excretion was not increased.(6)
Liu, Y L et al. in 1983 reported their research results on the chemical constituents of
Fagopyrum cymosum
(Trev.) Meisn. Liu indicated that they had isolated three components of
Fagopyrum cymosum
(Trev.) Meisn. Component A is the main constituent in
Fagopyrum cymosum
(Trev.) Meisn and accounts for its pronounced therapeutic effect on pulmonary abscess. The octamethylether, octamethylether diacetate and decanacetate derivatives were prepared from this component. On the basis of spectroscopic analyses, degradation products and physico-chemical constants, component A was identified as the dimer of 5, 7, 3′, 4′-tetrahydroxyflavan-3-ol (C4-C8 linked), named dimeric procyanidin. Components B and C were identified as hecogenin and &bgr;-sitosterol respectively.(7)
Liu T C published an article in 1983 analyzing the growth and accumulation of active constituents during different development stages of
Fagopyrum cymosum
rhizome. The author reported that condensed procyanidin, the active constituent of
Fagopyrum cymosum
rhizome was observed and studied, including its existence in different parts of the plant and at different development stages, and its development in the root, stem and the above-the-ground part in different growth stages. The paper showed that the amount of condensed procyanidin is higher in the root and stem and is highest from mid-October till the withering season. The content rapidly increases from mid-June and reaches its highest level in late October.(8)
Yao R C et al. reported anti-tumor active constituents of cymose buckwheat in China in 1989. The researchers reported that they had extracted the active portion (A) from rhizome of cymose buckwheat using ethanol extraction, macroporous resin (D101) column chromatography and acetone extraction process. Chemical analysis revealed that A is a compound of proanthocyanidin, from which, in comparison with standard substances, (−) epicatechin, 3-galloyl (−) epicatechin, procyanidin B-2 and B-4, and 3,3′-digalloyl pro
Chen Bo
Guo Oiyu
Han Pei
Zhu Hongwu
Chan Albert Wai-Kit
Elkins Mark
Witz Jean C.
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