Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a root – bulb – tuber – corm – or...
Reexamination Certificate
2001-02-12
2003-11-04
Tate, Christopher R. (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a root, bulb, tuber, corm, or...
C424S078010, C424S725000, C424S773000, C514S892000
Reexamination Certificate
active
06641851
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates in general to a laxative preparation obtained of a selective bioactive exact from the rhizomes and roots of PICRORRHIZA KURROA and its method for manufacture and also to a method for treatment of human beings for relieving constipation using the same comprising administering the laxative preparation in selective suitable pharmaceutical dosage forms to human beings and other non-human mammals.
BACKGROUND OF THE INVENTION
One of the most commonest digestive problems encountered amongst human beings, particularly amongst children and aged people, is constipation, which usually occurs due to abnormal motility pattern in the colon and thus, delayed propulsion of the intestinal contents. It also occurs due to weak peristaltic movements or defecation reflex leading to hindrance in propagation.
Laxatives known to be used for treatment of constipation include synthetic chemical compounds such as phenolphalein, bisacodyl (diphenyl methane laxatives), milk of magnesia and the like. These laxatives, although effective, have been found to exhibit undesirable side effects, the commonest of which are abdominal pain, cramps, nausea, skin rash, intestinal and rectal bleeding.
Bulk laxatives available in the market, such as Isaphgul husk, Psyllum and Calcium polycarbophil are effective only in respect of mild to moderate constipation, and have to be administered in high doses which is not desirable keeping in view the after effects of such application.
In recent years, herbal laxatives have grown in importance owing to their attributes of lack of undesirable side effects and thus ensuring safe and yet effective application. Natural laxatives that are available commercially include NATURE'S REMEDY (Smith Kline Beecham), SENOKOT (Purdue Frederick) and GENTLE NATURE (Novartis). Such known natural laxative formulations usually comprises Aloe, Senna, Cascara sagrada and other plants. The laxative action of the above mentioned herbal laxatives is mainly due to the presence of a class of chemical compounds in such plants viz. anthraquinones and its glycosides. Such class of compounds produces severe side effects including intestinal contractions, abdominal pain, cramps and damage to the kidneys when used in large doses or for a prolonged period.
Picrorrhiza kurroa is a perennial herb usually with long rhizome and is commonly known as kutki and belongs to the family Scruphulariacese. It grows throughout alpine Himalayas from Kashmir to Sikkim. The root is used as bitter, stomachic and in large doses as cathartic. It is also used in favor, dyspepsia, and nervous pain of stomach and also as an antiperiodic and cholagogue [Chopra R N, Nayer S L, Chopra I C, Glossary of Indian Medicinal Plants (CSIR, New Delhi) 1956: 1921.] The root contain bitter principles viz. Cucurbitacina, iridoid glycosides for example kutkoside and picroside, phenyl ethanoids, phenolics like vanillic acid, apocynin etc. Cucurbitacins are associated with Antitumor, Adaptogenic and Immunological and related activities while wide range of biological activities are attributed to Iridoid glycosides such as cardiovascular, antihepatotoxic, cholertic, hypoglycemic and anti-inflammatory etc. [Das P K, Raina M K. J Res Indian Med. 1967:1: 213.] have reported that water soluble fraction of alcoholic extract of Picrorrhiza kurroa possesses a non-specific anti-spasmodic activity. [Das P K, Tripathi R M, Agarwal V K, Sanyal A K. Indian Journal of Experimental Biology 1976:14: 456.] reported that kutkin, the bitter glucoside and its constituent organic acids cinnamic and vanillic acids as laxative principles.
However, inspite of the above reported known uses of extracts of PICRORRHIZA KURROA as laxative no effective laxative preparation for humans from such extract could be formulated till date possibly due to not so encouraging laxative character of extracts of PICRORRHIZA KURROA available from the teachings of the above reported prior art.
OBJECTS OF THE INVENTION
It is thus the basic object of the present invention to carry out a detailed study of the laxative property of extracts of PICRORRHIZA KURROA and provide for an effective laxative preparation in the form of a selective bioactive extract of PICRORRHIZA KURROA which would be gentle, safe and effective, free of undesirable side effects and capable of relieving severe constipation.
Another object of the present invention is to isolate from PICRORRHIZA KURROA an effective selective bioactive extract which would enable preparation of a herbal laxative for humans on a commercial scale.
It is a further object of the present invention to provide a method for obtaining the selective bioactive extract of PICRORRHIZA KURROA suitable for use as a laxative for humans.
Yet further object of the present invention is to formulate the effective dosage for administration of the abovesaid selective bioactive extract for use as laxative for humans.
Yet another object of the present invention is directed to providing various dosage forms of the selective bioactive extract of PICRORRHIZA KURROA for use as laxative for humans.
It is still further object of the invention to provide a method for treatment of human beings for relieving constipation using the selective bioactive extract of PICRORRHIZA KURROA as an effective laxative.
Yet further object of the present invention is to not only provide for the selective most effective bioactive extract of PICRORRHIZA KURROA for laxative preparation but also to determine the reasons for superiority of such fraction.
SUMMARY OF THE INVENTION
Thus according to the basic aspect of the present invention there is provided
a laxative preparation comprising bioactive chloroform or methanolic extract of rhizomes or roots of Picrorrhiza Kurroa and optionally pharmaceutically acceptable carrier thereof.
In accordance with a preferred aspect of the present invention the laxative preparation of the invention comprise 50 to 500 mg preferably 50 to 250 mg of bioactive chloroform extract of rhizomes or roots of Picrorrhiza Kurroa in a pharmaceutically acceptable form with or without a pharmaceutically acceptable carrier thereof.
In accordance with a further preferred aspect of the present invention the laxative preparation of the invention comprise 50 to 500 mg of bioactive methanolic extract of rhizomes or roots of Picrorrhiza Kurroa in a pharmaceutically acceptable form with or without a pharmaceutically acceptable carrier thereof.
The laxative activity of the above disclosed selective natural extract either methanol extract or chloroform extract of PICRORRHIZA KURROA is surprisingly found to have unexpected superior efficacy as laxative as compared to the reported ethanolic extract of the same plant. Also, the selective extract of the invention is found to be safe and effective and displayed no undesirable side effects in humans. Importantly the above selective extract also does not require any other plant extracts/chemicals to synergise its beneficial action.
The active extract may be administered in different dosage forms like capsules, tablets and syrup. The above dosage can be administered in different dosage forms like capsules, tablets and as syrup in which 5 ml may contain 50-250 mg of active extract for clinical administration in human beings to produce significant laxative action without any undesirable side effects.
In accordance with another aspect of the present invention there is provided a method of extraction of the selective chloroform/methanolic extract of the PICRORRHIZA KURROA suitable as laxative for humans preferably comprising:
a) Subjecting the rhizomes/roots of the PICRORRHIZA KURROA to percolation at room temperature by occasional stirring preferably for a period of about 24 hours;
b) Soxhalation of the material with solvents selected from chloroform and/or methanol on heating mantle or on water bath at optimum temperature (40-60° C.) until extraction is completed;
c) Refluxing the material with the solvents selected from chloroform and/or methanol and concentrating
Babu Uddagiri Venkanna
Mitra Shankar Kumar
Ranganna Marikunte Venkata
Flood Michele C.
Pendorf & Cutliff
Tate Christopher R.
The Himalaya Drug Company
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