Pharmaceutical composition comprising extract from plant...

Details Pharmaceutical composition comprising extract from plant... Pharmaceutical composition comprising extract from plant...

2001-12-18

2003-04-15

Lilling, Herbert J. (Department: 1651)

Drug, bio-affecting and body treating compositions

Plant material or plant extract of undetermined constitution...

C424S452000, C424S465000, C424S499000, C514S470000, C514S526000

Reexamination Certificate

active

06548086

ABSTRACT:

FIELD OF THE PRESENT INVENTION
Pharmaceutical composition and a method useful for treating immunodeficiency in animals or human beings, said composition comprising effective amount of the extract obtained from any part of plant
Cryptolepis buchanani,
either as such or its individual constituents singly or in composition with each other, optionally associated with pharmaceutically acceptable additives
BACKGROUND AND PRIOR ART REFERENCES
Cryptolepis buchanani
Roem. & Schult. (Family Asclepiadaceae) is distributed throughout hot deciduous forests of India and holds a very prestigious position in Ayurveda.
It is a very useful plant because of its multiple uses as a traditional medicine, such as anti-diarrheal, anti-bacterial, anti-ulcerative, anti-inflammatory, blood purifier and for lactation in women [Bhakuni, D. S., Dhar, M. L., Dhar, M. M., Dhawan, B. N., and Mehrotra, B. N.,
Ind. J. Expt. Biol.,
7: 250-262 (1969), Bhav Prakash, Commentary on Bhav Prakash Nighantu edited by C. K. Chunekar, Chowkhamba Vidya Bhavan, Varanasi 4
th
edition: 427 (1969)].
Ethanolic extract of roots and stem show hypotensive, central nervous system depressant and antiamphetaminic activity [Joshi, M. C., Patel, M. B. and Mehta, P.
J. Bull. Med. Ethno. Bot. Res.,
1: 8-24 (1980)]. Ethanolic extract of aerial parts of plant shows diuretic activity [Dhawan, B. N., Patnaik, G. K., Rastogi, R. P., Singh, K. K. and Tandon, J. S.,
Ind. J. Expt. Biol.,
15: 208-219 (1977)].
Root bark is used in rheumatic pains [Mudgal, V. and Pal, D. C., Bull.
Bot. Surv. Ind.,
22: 59-62 (1980)]. Stem constituents are alkaloids and triterpenes, leaves constituents are &agr; and &bgr; amyrin (Asolkar, L. V., Kakkar, K. K. and Chakre, O. J., Glossary of Indian Medicinal Plants with active principles, part-1, A-K., 1965-1981(1992)] and cryptolepine—the methyl—quinolanol alkaloid of
cryptolepis sanguinolenta.
Pyridine alkaloid, buchanine [Dutta, Sunil K, Sharma, Batuk N, Sharma, Priya V.
Phytochemistry
17, 2047(1978)] and a cardenolide cryptosin, 7,8-Epoxy-3,11,14-trihydroxy-12-Oxocard 20 (22)-enolide [Venkateshwara R; Narendra N; Viswametra M. A; Vaidyanathan C. S.;
Phytochemistry
28, 1203 (1989)] are the major chemical constituent of the plant. Apart from these chemical constituents cryptanoside—A to D and germenicol [Purshothman K. K; Saradha V; Connolly J. D; Rycroft D. S,
Rev. Latinomer Quim.,
19, 28 (1988)], 1,3,6-trinicotinoyl-&bgr;-D-glucopyranoside and 1,3,6-trinicotinoyl-&agr;-D-glucopyranoside, n-trinicontanol, n-triactonoic acid, &bgr;-amyrin and &bgr;-sitosterol glucoside [Dutta S. K; Sharma B. N; Sharma P. V.,
Phytochemistry,
17, 2047 (1978), Dutta S. K; Sharma B. N, Sharma P. V; (1980)
Phytochemistry,
19, 1278 (1980)].
The alcoholic extract of the root shows the presence of sterols, reducing sugars and traces of glycosides and exhibited antiplatelet effects in vitro in humans, rabbits and rats. In rats, it exhibited ADP- aggregation in vitro with delayed onset and prolonged action. It exhibited an indirect fibrinolytic action in the rat possibly by causing the release of plasminogen activators from the vascular endothelium [Oyekan, A. O., Botting, J. H. and Noamesi, B. K.,
General Pharmacol.,
19: 223-227 (1988)].
A large variety of herbal drugs mentioned in Ayurveda, for their immunomodulating, adaptogenic and rejuvenating properties have been under study [Nayar, R. C. A review on the Ayurvedic drug Sariva.
J. Res. Ind. Med. Yoga. And Homoe.,
14 (2): 69-79 (1979); Wagner, H. and Proksch, A. In progress in medicinal and aromatic plants. Research vol. 2, Eds. Farnworth, N., Hikino, H., Wagner, H., Academic Press London 1983, Labadie, R. P. Immunomodulatory compounds In: Bioactive natural products Eds. Stevan M. Colegate, Russel, J. Molyneux, CRC Press Inc., 279-317 (1993)].
These plants are believed to promote positive health and maintain organic resistance against infections by re-establishing body equilibrium and conditioning the body tissues [Bhagwandas, Fundamentals of Ayurvedic Medicine, Bansal Co., Delhi, India, ix-xvi (1978)]. Hence the drugs of plant origin are gaining increasing popularity and are being investigated for correction of immunological disorders [Aboolenein, A. A., Back to medicinal plants therapy. In the history of medicinal and aromatic plants; Proceedings of the second international congress. Alexandria, Egypt, ed. Abdallah, A., Hamdard Foundation Press, Pakistan, 40-44 (1980); Hikino, H., Recent research on oriental medicinal plants, In: Economic and Medicinal Plant Research Eds. Wagner, H., Hikino, H. and Farnsworth, N. R. (Academic Press, London): 53-85 (1985)].
Immunomodulation is a process, which alters the immune system of an organism by interfering with its functions. This interference results in either immunostimulation, an enhancement of immune reaction or immunosuppression that imply mainly to reduce resistance against infections and stress which may be because of environmental or chemotherapeutic factors [Patwardhan, B., Kulbag, D., Patki, P. S. and Nagsampagi, B. A.,
Indian Drugs,
28 (2): 56-63 (1990)]. Immunostimulation and immunosuppression both are needed to be tackled depending on the type of immunological disturbance. Recently, search for better moieties with these activities is becoming the field of major interest. Research focussed on the development of immunomodulators is directed towards activities that can be expressed in terms of stimulation or inhibition of immune factors and their integrated function [Labadie, R. P. Immunomodulatory compounds In: Bioactive natural products eds. Stevan M. Colegate, Russel, J. Molyneux, CRC Press Inc., 279-317 (1993)].
Recently the understanding of research on immuno-modulators has come up as a new field of immunopharmacology. Immunomodulation is a strategy for overcoming incurable autoimmune diseases involving cancer, AIDS, arthritis and allergies. An in-depth study of the immune system is supposed to provide both the theoretical and therapeutic background of many chronic disorders.
Advancement in the field of surgery, which has made organ transplantation possible, is endowed with a serious problem of organ rejection, which infact comes under the preview of immunology associated with immune system. Proper handling of this situation through modification of immune response can give new lease of life to patients with organ transplant. Delayed type hypersensitivity (DTH) and allergy manifested through altered reactivity due to previous exposure to an antigen is most of the time deleterious rather than beneficial to the individual. In the modern day life, extensive exposure to industry based pollutants/xenobiotics has resulted in emergence of a variety of immune deficiencies or hypersensitivity, situations which call for changed strategy for handling the patients, where immunology plays the pivotal role.
Keeping these emerging immunological disorders in view, major efforts have to be directed towards the formulation of new strategies, to modulate the immune responses, to permit effective treatment of various ailments associated with immune system and thus the development of a safe and effective immunomodulator for clinical use has become a major goal for many pharmaceutical investigators worldover.
Keeping in view the high reputation of
Cryptolepis buchanani
in Ayurvedic system of medicine, it was tempting to speculate that the restorative and rejuvenating power of this plant might be due to its action on immune system of the organism as no mention is made about its such effect anywhere in literature.
Liver has a pivotal role in regulation of physiological processes. Toxic chemicals and infections mainly cause liver diseases. Hepatocyte alterations of various origins result in acute and chronic dysfunctions, which may be lethal [Decker K. and Keppler D. Rev.
Physiol. Biochem. Pharmacol.,
71, 79-106 (1974)].
Liver disorders are still the major hazard both in u

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