Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-03-28
2002-09-24
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S732000, C424S734000, C424S756000, C424S757000, C424S725000
Reexamination Certificate
active
06455077
ABSTRACT:
PRIORITY APPLICATION
The present application claims priority under the Paris Convention to Indian patent application entitled, “A Herbal Composition and Process for the Manufacture of such Composition for the Management of Gynecological Disorders,” filed on Mar. 28, 2000 and assigned Indian Application Ser. No. 344/Del/2000.
FIELD OF INVENTION
The present invention is a herbal composition enriched with plant coagulate for the management of gynecological disorders and a process for the manufacture of such composition. In one embodiment, the herbal composition includes selected herbs in predetermined ratio ranges in combination with plant coagulate. The method of manufacture involves selective solvent extraction of crude herbs, in contrast to conventional aqueous extraction, to improve efficacy. The extract prepared by this method, enriched with plant coagulate, is useful in the management of Gynecological disorders and to prevent/treat anaemia due to excessive bleeding associated with menstrual disorders.
BACKGROUND OF INVENTION
Gynecology pertains to diseases of the female, but the term is generally used for diseases related to the female genital organs. Menstrual disorders such as dysfunctional uterine bleeding, dysmenorrhoea, irregular periods and pre-menstrual syndrome are common clinical problems in Gynecology.
Dysfunctional uterine bleeding (DUB) is defined as abnormal bleeding from the uterus in the absence of organic disease of the genital tract. Bleeding that occurs at intervals less than 21 days or more than 36 days, lasts longer than 7 days, or involves blood loss greater than 80 ml is considered abnormal. Dysfunctional uterine bleeding is characterized by menorrhagia (excessively profuse or prolonged uterine bleeding occurring at regular intervals), metrorrhagia (irregular, acyclic uterine bleeding occurring at frequent intervals), menometrorrhagia (excessive uterine bleeding occurring at irregular intervals), and polymenorrhea (bleeding occurring at regular intervals of less than 21 days). Potential causes of abnormal bleeding are numerous and include, but are not limited to, menopause, pregnancy, endometrial cancer, or fibromyomata, and thus the diagnosis of DUB must be made after careful investigation to exclude these other causes (Galle et al., Postarad Med, 93(2), 73-76 (1993)). Dysfunctional uterine bleeding is divided into anovulatory and ovulatory types. In most cases DUB is associated with anovulation (Bayer et al., JAMA, 269(14), 1823-1828 (1993)). Abnormal bleeding occurs in anovulatory cycles because of oestrogen withdrawal or oestrogen breakthrough bleeding. Oestrogen breakthrough bleeding occurs when there is continuous oestrogen stimulation of the endometrium not interrupted by cyclical progesterone secretion and withdrawal.
There are two approaches for the management of Gynecological problems—conservative and surgical. Conservative approach includes hormonal treatment with estrogenic or progestational agents (Bayer et al., JAMA, 269(14), 1823-1828 (1993)), nonsteroidal anti-inflammatory drugs and/or treatment with Ayurvedic preparations.
The constraints with the hormonal treatment and NSAID are tabulated (U.S. Pat. No. 5,552,416, Sep. 3, 1996; Shaw's textbook of Gynecology, 319, 1992)
THERAPY
OBJECTIVE(S)
LIMITATION(S)
GnRH agonists
Blocks oestrogen
By injection
secretion at
Accelerates osteoporosis
pitutary axis level
Limited to preoperative use
Side effects
Oral Progestagens
Corrects oestrogen and
Limited effectiveness
Progestagen ratio
Side effects
Nonsteroidal
Local endometrial
Limited effectiveness
Anti-inflammatory
actions
Non-specific agent
Agents
Side effects
Oestrogen
To raise blood
Risk of developing
oestrogen level
carcinoma of breast
and endometrium
Because of the side effects of the hormones and NSAIDS, physicians are looking for alternative options for treatment with minimum side effects.
(1) Ayurvedic literature suggests the use of herbs such as
Saraca indica
Linn. (Ashoka) (Bhavaprakasa Nighantu, ninth edition, 500-501 (1993)),
Symplocos racemosa
Roxb.(Lodhra) (Bhavaprakasa Nighantu, ninth edition, 128-130 (1993)),
Woodfordia fruticosa
kurtz (Dhatki pushpa) (Bhavaprakasa Nighantu, ninth edition, 109-110 (1993)) etc. in the treatment of gynecological disorders.
(2)
Saraca indica
Linn. was studied for its uterine activity to understand its phenomenal use in gynecological conditions (Satyavati et al., Indian J Med Res, 58, 7 July, 1970).
(3) The following citations of different herbs exemplify known roles of herbs in the management of gynecological conditions.
(i) In Pradara (meno-metrorrhagia) one should take cold milk boiled with the decoction of ashoka bark. (Vrndamadhava 63.5)(Classical uses of Medicinal Plants by P. V. Sharma, 27, 1996).
(ii)
Symplocos racemosa
Roxb. in combination with sugar is recommended in the treatment of menorrhagia and other uterine disorders (The Wealth of India, Vol. X, 90, 1976).
(iii) Lodhra is useful in women's diseases (Classical uses of Medicinal Plants by P. V. Sharma, 333, 1996).
(a) In the eighth month, by taking Lodhra, Pippali and honey mixed together with milk, fetal movement becomes normal (Harita-samhita.3.50.5).
(b) Lodhra and Alabu leaves in equal parts should be pounded and applied as paste in the vagina in order to treat gynecological conditions. (Bhavaprakasa.ci.70.12).
(c) Lodhrasava is a popular herbal formulation for the treatment of women's diseases.
(iv)
Woodfordia fruticosa
kurtz. is used in bowel complaints and haemorrhages and is also administered in menorrhagia and seminal weakness (The Wealth of India, Vol. X, 586-587, 1976).
(v) Dhataki pushpa is used in Leucorrhoea and for conception (Classical uses of Medicinal Plants by P. V. Sharma, 204, 1996).
(a) Powder of Dhataki or Amlaki in an amoutn of 10 gm mixed with profuse honey should be used in Leucorrhoea (Vrandamadhava 63.4).
(b) Nilotpala mixed with dhataki flowers and honey is used in the morning hours to ensure conception (Gadanigraha 6.59).
(vi) Mangifera indica (Amrasthi) is used in slackness of vagina (Classical uses of Medicinal Plants by P. V. Sharma, 40, 1996).
(a) Paste is made from mango seed (Kernel), honey and camphor and applied to vagina in order to make the vagina contracted and firm. (Sarangadhara-samhita.3.11.11)
(4) Ashokarishta, a classical ayurvedic fermented product has been used to treat menstrual disorders. (Bhaishajya Ratnavali, 704, 1988).
Based on the long history of using herbs as cited above, many Ayurvedic classical and proprietary formulations contain these herbs for the treatment of gynecological problems.
There are limitations, however, to using these formulations and, therefore, there exists room to improve upon them. Below is a description of limitations present in the prior art.
(1) First, it is conventional practice to perform an aqueous extraction of crude herbs for the manufacture of Ayurvedic preparations. This, however, often results in the incomplete extraction of actives present in the plants, due to their poor solubility in water. For instance, commonly occurring plant flavonoids have estrogenic activity (Miksicek R J, Mol Pharmacol 1993, Jul.;44(1): 37-43). Even the herbs containing flavonoids are traditionally extracted with water in the manufacture of many Ayurvedic preparations. This results in lesser flavonoid content in the extract and hence is expected to show less activity.
(2) Second, the patients suffering from menstrual disorders are likely to develop anemia due to excessive bleeding. Commonly, there is a need to treat both the problems simultaneously. Unfortunately, most of the Ayurvedic preparations are designed to tackle menstrual problems ignoring the prophylactic treatment for anemia.
Plant coagulate mainly finds its application as a food supplement. The nutritional profile of plant coagulate includes protein, fat, carbohydrates, vitamins such as carotene, niacin, etc. and minerals such as calcium, phosphorous, magnesium, potassium, zinc, copper and iron.
Several publications claim the successful use of Plant coagulate in the management of m
Duggal Ramesh Kumar
Katiyar Chandra Kant
Rao Bodapati Venkata Jagannadha
Dabur Research Foundation
Davis Ruth A.
King & Spalding
Lankford , Jr. Leon B.
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