Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Patent
1997-11-10
1999-05-18
Spivack, Phyllis G.
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
514468, 514680, A61K35/78;31/34;31/12
Patent
active
059049235
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention relates to pharmaceutical compositions for the treatment of alcohol addiction, characterized in that they contain--as the active principle--a purified lipophilic extract of Salvia miltiorrhyza Bunge. The invention also relates to a process for the preparation of the purified lipophilic extract of Salvia miltiorrhyza Bunge, and the extract thus obtained. Furthermore, the invention relates to the use of the pure active principles contained in this extract (Tanshinone IIA and Miltirone) in the treatment of alcohol addiction and to pharmaceutical compositions for said treatment which contain as the active principles Tanshinone IIA and/or Miltirone.
BACKGROUND OF INVENTION
Alcohol abuse and alcohol addiction, phenomena which can be collectively referred to by the term alcoholism, represent a serious problem for the whole of modern society (Gessa G. L., Bisogno compulsivo di bere e II, 5 (1994)). In Italy, for example, more than 9% of the population (about 5 million people) are heavy drinkers and more than 1 million people are alcohol-addict (Calamo-Specchia F. P.--Epidemiologia dell'alcolismo in S.I.A.! Mediserve, Rome, 295-301, (1991)). These figures become much higher if we consider countries such as the United States of America where there are more than 13 million alcohol-addicts. Alcohol abuse and actual alcohol addiction result in an enormous outlay of public money (recently, since 1991, in the United States about 200 thousand million dollars a year have been spent) and are the cause of enormous social and psychological damage for the individuals involved.
The existing approaches for the treatment of alcoholism, in addition to those of a psychological nature (group therapy, etc.), consist in the use of drugs such as disulfiram and calcium carbamide which act on the metabolism of alcohol, inhibiting hepatic aldehyde-dehydrogenase and therefore raising the hematic levels of acetaldehyde, with all the undesiderable phenomena which occur each time ethanol is taken.
According to the present state of the art, the sole plant whose derivatives have been used for the treatment of alcoholism is the Pueraria lobata (Radix puerarie), which is widely used in traditional Chinese medicine and forms the subject of Patent Application WO 93/00896.
SUMMARY OF THE INVENTION
It has now been surprisingly found that the purified lipophilic extract of the roots of Salvia miltiorrhyza Bunge can be used with success for reducing the voluntary consumption of alcohol and other drugs which induce addiction. Furthermore, individual pure products isolated from the extract, such as Tanshinone IIA and Miltirone, have also proved to be useful. The dried roots of Salvia miltiorrhyza Bunge (Danshen, Radix Salviae miltiorrhyzae) are officially listed in the Chinese Pharmacopeia; they are widely used for the treatment of menstrual disturbances, cardiovascular diseases such as, for example, angina pectoris and abnormalities of platelet function, as well as insomnia (Tang, W. Eisenbrand, G., Salvia miltiorrhyza Bge., in Chinese drugs of plant origin; Chemistry, Pharmacology, and Use in Traditional Chinese Medicine, pp. 891-902--Springer-verlag, Berlin (1992); Kee Chang Huang, Antianginal Herbs in The Pharmacology of Chinese Herbs, pp.81-84--CRC Press, Boca Raton (1993)).
The use of hydro-alcoholic extracts of Salvia miltiorrhyza for the topical treatment of excess fat deposits is also known (Italian Patent 1,239,281).
DESCRIPTION OF THE INVENTION
The extract according to the invention, unlike that which is known, is of the lipophilic type and is obtained by extraction of the roots of Salvia miltiorrhyza with acetone, at temperatures of between about 20 and 50.degree. C., using a drug/solvent ratio (w/v) of between 1:2 and 1:10, preferably about 1:5. Following concentration down to about 1/20th to 1/50th of the initial volume, water and a solvent which is immiscible in water are added. The acetone is removed by means of repeated washings with water while the organic phase containing the active pr
REFERENCES:
Chang et al., J. Org. Chem. 55(11), 3537-43, 1990.
"The Merck Manual of Diagnosis and Therapy", Sixteenth Edition, Merck & Co. Inc., 1992, pp. 1551-1555.
Abstract No. 86739S, "Antioxidant Activity of Quinones Extracted From Tanshen," Chemical Abstracts, vol. 117, No. 9, Aug. 31, 1992, p. 429, col. 1.
Chi-Ming Lee et al., "Miltirone, a central benzodiazepine receptor partial agonist from a Chinese medicinal herb Salvia Miltiorrhiza," 1991, Neuroscience Letters, vol. 127, pp. 237-241.
Database Napralert STN, C. P. Li, "Chinese Herbal Medicine", AN92:5003, 1974.
Bombardelli Ezio
Morazzoni Paolo
Indena S.p.A.
Spivack Phyllis G.
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