Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from zingiberaceae
Reexamination Certificate
2000-08-26
2001-08-14
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
C424S773000
Reexamination Certificate
active
06274177
ABSTRACT:
FIELD OF THE INVENTION
The present invention is related to a method of preparing an extract potent in anti-inflammation and anti-platelet aggregation from
Zingiber officinale.
BACKGROUND OF THE INVENTION
Chinese crude drugs or spices eg.
Zingiber officinale, Eugenia caryophyllata, Allium sativum
, have been used in medicine and in flavoring foods. Crude ginger is used as an anti-emetic and expectorant, an anti-tussive and accelerator of the digestive organs. Semi-dried old crude ginger is also used for stomachache, chest pain, low back pain, cough, common cold and as a cure for a form of edema being called “stagnate of water”. Zingerone is the major component which accounts for the spicy character of ginger; gingerol and shogaol are other pungent components in ginger. Gingerol has cardio-tonic action, suppresses the contraction of isolated portal veins in mice, and modulates the eicosanoid-induced contraction of mouse and rat blood vessels. Shogaol exhibits pressor response. Both gingerol and shogaol are mutagenic, whereas zinger and zingerone have been found to exhibit antimutagenic activity. Shogaol has inhibitory activity on the carrageenin-induced paw edema and platelet aggregation [U.S. Pat. No. 5,804,603, Background of the Invention].
Heretofore, many reports have shown that
Zingiber officinale
exhibits various physiological activities. Typical examples include a cancer metastasis suppressing agent disclosed in Japan patent publication No. 7-258104; a synthesis promoter for neurotropic factor, which is effective for nerve deteriorative diseases such as Alzheimer's dementia or Parkinson's disease, disclosed in Japan patent publication No. 7-25777; an anti-rheumatic agent disclosed in Japan patent publication No. 6-293653, U.S. Pat. Nos. 5,494,668 and 5,683,698; an antimicrobial composition disclosed in Japan patent publication No. 6-227931; and an analgesic composition disclosed in Japan patent publication No. 6-107556. Ginger contains 1-4% essential oil (oleoresin). During the last 45 years many chemical investigations have been carried out on the constituents of the essential oil. Altogether more than 200 different volatiles have been identified in essential oil wherein the pharmacological activity is confined. The essential oil contains a mixture of various terpenes as well as some other non-terpenoid compounds. Although this is mostly speculative, the experimental data and observations suggest that ginger inhibits both the cyclooxygenase and lypoxygenase products, i.e. it can be a dual inhibitor of eicosanoid synthesis. In all 56 patients (28 with rheumatoid arthritis, 18 with osteoarthritis and 10 with muscular discomfort) used powdered ginger against their afflictions. Amongst the arthritis patients more than three-quarters experienced, to varying degrees, relief in pain and swelling. All the patients with muscular discomfort experienced relief in pain. None of the patients reported adverse effects during the period of ginger consumption which ranged from 3 months to 2.5 years. (Srivastava and Mustafa; Medical Hypotheses; 1992; 39 342-348).
Non-steroidal anti-inflammatory drugs have three major actions, all of which are related to inhibition of cyclo-oxygenase resulting in decreased formation of prostanoids. Firstly, an anti-inflammatory action achieved by reduced production of vasodilator prostaglandins (PGE2, PGI2) which means less vasodilation and, indirectly less edema. Secondly, an analgesic effect achieved by reduced prostaglandin production (less sensitization of nociceptic nerve endings to the inflammatory mediators bradykinin and 5-hydroxytryptamine). Thirdly, an antipyretic effect which is probably due to a decrease in the mediator PGE2 generated in response to inflammatory pyrogens, much as interleukin-1. Since ginger inhibits prostanoid synthesis and also products of 5-lipoxygenase, its ameliorative effects in arthritis and muscular discomforts could be related to reduced formation of prostanoids and leukotrienes. Because of such a possibility a decrease in the carageenan-induced edema formation in the rat's paw after 3 g of ginger extract administration has been demonstrated and the potency of the extract in the acute inflammation test appears to be comparable to that exhibited by acetyl salicylic acid reported in the same study. (Mascolo N. et al Journal of Ethnopharmocology 1989, 27, 129-140).
SUMMARY OF THE INVENTION
The present invention provides extracts from rhizomes of ginger which show an activity in an in vitro anti-platelet aggregation test and an inhibitory activity on the carrageenin-induced paw edema. The extracts are prepared by extracting rhizomes of ginger with an organic solvent (such as ethyl ether, acetone, methanol and ethanol) or supercritical CO
2
, or by steam distilling rhizomes of ginger to obtain a crude liquid, and subjecting said crude liquid to a reverse phase chromatography to obtain the extracts containing shogaols, gingerols and/or dehydrogingerdione.
DETAILED DESCRIPTION OF THE INVENTION
As introduced in the Background of the Invention, ginger has been used for anti-inflammation and pain relief.
The present invention is to provide an effective method of preparing a product potent in anti-inflammation and in anti-platelet aggregation from rhizomes of ginger. The potent product prepared in accordance with the method of the present invention has a substantially constant composition, so that the pharmaceutical effects thereof are definite.
The effective method of preparing product potent in anti-inflammation and in anti-platelet aggregation from rhizomes of ginger according to the present invention comprises the following steps:
a) preparing a crude liquid from rhizomes of ginger;
b) introducing the crude liquid to a reverse phase chromatography column, and eluting the column with water, a first eluent and a second eluent in sequence, said second eluent having a polarity weaker than that of the first eluent but stronger than that of chloroform, so that a first eluate resulting from elution of the first eluent and a second eluate resulting from elution of the second eluent are obtained;
c) removing the first eluent from the first eluate by evaporation, so that a first concentrated eluate is obtained and is able to be used as the potent product; and
d) removing the second eluent from the second eluate by evaporation, so that a second concentrated eluate is obtained and is able to be used as the potent product;
wherein step a) comprises steps i) to iv), or comprises step I), step I′), or step I″), wherein said steps i) to iv) are:
i) shedding fresh rhizomes of ginger and filtering the resulting mixture to obtain a filtrate and a residue;
ii) extracting the filtrate with a first organic solvent, recovering the resulting extraction solution of the first organic solvent, and evaporating the first organic solvent from the extraction solution to obtain a first concentrated extraction solution;
iii) extracting the residue with a second organic solvent, recovering the resulting extraction solution of the second organic solvent, and evaporating the second organic solvent from the extraction solution to obtain a second concentrated extraction solution; and
iv) combining the first concentrated extraction solution and the second concentrated extraction solution to obtain the crude liquid;
said step I) is:
I) extracting powder of dried rhizomes of ginger with the second organic solvent, recovering the resulting extraction solution of the second organic solvent, and evaporating the second organic solvent from the extraction solution to obtain the crude liquid;
said step I′) is:
I′) steam distilling powder of dried rhizomes of ginger, and concentrating the resulting distillate by evaporation to obtain the crude liquid; and
said step I″) is:
I″) extracting powder of dried rhizomes of ginger with supercritical CO
2
, recovering the resulting extraction solution of the supercritical CO
2
, and evaporating CO
2
from the extraction solution to obtain the crude liquid.
The product
Ko Feng-Nien
Kuo Sheng-Chu
Teng Che-Ming
Wu Tian-Shung
Lilling Herbert J.
National Science Council
Walker L.L.P. Jackson
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