HERBAL COMPOSITIONS FOR HEPATIC DISORDERS

Abstract: The present invention relates to compositions comprising the herbs Salvia miltiorrhiza and Polyporus umbellatus, or extracts thereof, which are useful in treating hepatic disorders, particularly those with viral aetiology. The compositions may comprise other herbs or their extracts, and may be useful for treating hepatic disorders other than those caused by viral infection.

Description: HERBAL COMPOSITIONS FOR HEPATIC DISORDERS TECHNICAL FIELD This invention relates to a new medicinal compositions and methods of treating hepatic disorders. BACKGROUND ART Hepatic disorders, in particular those caused by viral infections, are a major health problem and the successful treatment of hepatic diseases poses a great challenge to the medical profession. With respect to hepatic diseases caused by viral infection, currently patients in advanced stages of the infection cycle (chronic hepatitis) with, for example, hepatitis C virus are treated with Interferon ("IFN") with only about 25% success rate. IFN is not readily available to patients and a six-month course of IFN therapy costs about $3000. It also gives rise to several side-effects such as severe flu symptoms, lethargy, hair loss and undesirable tastes in the mouth. IFN acts against the virus via the immune system and does not reverse any physiological abnormalities or damage caused by the infection eg. hepatic cirrhosis, diminished spleen function, etc. Furthermore, as there is a number of hepatic disorders which are not caused by viral infection, the administration of INF to patients with non-viral hepatic disorders would be ineffective. It is an object of the present invention to provide an effective method of and medication for, treatment of both viral and non- viral hepatic disorders which avoids or at least ameliorates one or more ofthe disadvantages of current treatments. SUMMARY OF THE INVENTION According to a first aspect, the invention consists in a composition comprising the herbs Salvia miltiorrhiza and Polyporus umbellatus, or extracts thereof. In a preferred embodiment the invention consists in a composition which further comprises at least one of the herbs Curcumae longa, Astragalus membranaceus, Loranthus parasiticus and Polygonum cuspidatum, or extracts thereof. In another preferred embodiment the invention consists in a composition which further comprises at least one ofthe herbs Poria cocos, Artemisia capillaris, Taraxacum mongolicum, Paeonia lactiflora, Panax pseudoginseng, Bupleurem falcatium, Crataegus pinnatifida, Glechoma longituba, Codonopsis pilosula, Lycium barbarum, Zizyphus jujuba, Gentiana manshurica and Glycyrrhiza uralensis, or extracts thereof. According to a second aspect the invention consists in a composition comprising the herbs Salvia miltiorrhiza, Polyporus umbellatus, Poria cocos, Artemisia capillaris, Taraxacum mongolicum, Paeonia lactiflora, Panax pseudoginseng, Bupleurem falcatium, Crataegus pinnatifida, Curcumae longa, Glechoma longituba, Astragalus membranaceus, Codonopsis pilosula, Loranthus parasiticus, Lycium barbarum, Polygonum cuspidatum, Zizyphus jujuba, Gentiana manshurica and Glycyrrhiza uralensis, or extracts thereof. According to a third aspect, the invention consists in a method of treating hepatic disorders comprising the step of administering to a patient requiring such treatment any one of the compositions described above. Preferably, the hepatic disorder treated is a non-viral hepatic disorder such as alcoholic hepatitis, cirrhosis or autoimmune liver disease. More preferably the hepatic disorder treated is caused by a viral infection such as hepatitis virus A, B or C infection. The treatment can be therapeutic or prophylactic, and may be administered orally or parenterally. The parenteral route could be topical, intravenous or subcutaneous. The treatment may be delivered in a single bolus dose, multiple doses or via a slow release device or a depot. DESCRIPTION OF THE PREFERRED EMBODIMENT In a preferred embodiment of the invention, the composition of the invention comprises Salvia miltiorrhiza and Polyporus umbellatus in the proportion of from 1:1 to 1:5 or 5:1. For example, these herbs may each comprise from 6 to 30% of the total weight of the herbal composition, the balance being made up for example by other herbs, preferably Curcumae longa (2-10%), Astragalus membranaceus (5-30%), Loranthus parasiticus (5-30%) and Polygonum cuspidatum (3-20%). Although the administration of a composition containing only Salvia and Polyporus will be effective in treating chronic hepatitis, the synergism between all the herbs render the administration of a combination containing each herb desirable. Thus, in a more preferred embodiment, the composition comprises each herb combined in the proportions given in Table 1. Various parts of each herb may be used and these include the root, stem, fruit or whole plant or tuber. The availability of the herbs and ease of concentrating the extracts provides a cheaper, alternative medicine which also does not give rise to undesirable side-effects. There is also a higher incidence of cure in that liver cirrhosis may be reversed and hepatic enzyme levels and microcirculation may be normalised, thus rendering this form of treatment applicable not only to hepatic disorders caused by virus infection but also those disorders caused by other agents and causes which can compromise liver function and microcirculation. The invention will now be described with reference to the following example to illustrate a preferred embodiment only and does not serve to limit the invention. EXAMPLE 1 The prferred method of preparing the compositions of the invention is to mix the cut, ground or powdered herbs listed in Table 1 and boil the mixture in a vat. The liquid is thus concentrated into a paste which can subsequently be processed further into tablets averaging about 170mg each, using procedures which conform to standard, General Manufactured Products (GMP) guidelines. TABLE 1: Medicinal composition comprising herbal extracts in pill-form. Powdered Herbs Weight Polyporus umbellatus root 16mg Salvia miltiorrhiza root 14mg Artemisia capillaris thunb 14mg Poria cocos root 12mg Taraxacum mongolicum plant 12mg Paeonia lactiflora root 1 Omg Astragalus membranaceus root 1 Omg Loranthus parasiticus stem lOmg Glechoma longituba plant 9mg Codonopsis pilosula root 9mg Polygonum cuspidatum root 9mg Gentiana manshurica plant 9mg Bupleurem falcatium root 7mg Crataegus pinnatiflda fruit 7mg Lycium barbarum fruit 7mg Zizyphus jujuba fruit 7mg Curcumae longa tuber 5mg Panax pseudoginseng root 3mg Glycyrrhiza uralensis root 5mg (colouring/coating) Consumption of 8 tablets three times daily, 30-60 minutes prior to meals with warm water is recommended for adults. Children may be prescribed half the adult dosage. The dosage and the formulation may be varied according to the condition treated and the concentration of active ingredients used in each dose. Thus, the dosage may range from 3 to 10 tablets three times daily, or more or less frequently as required. The compositions may also be administered as a liquid or in the form of a slow release formulation. EXAMPLE 2 An alternative method of preparing the compositions of the invention is to powder the herbs listed in Table 1 by crushing and grinding each herb after drying it in a machine in a known, conventional manner. The individual components are then formulated into tablets. EXAMPLE 3 A tablet form of the composition prepared according to Example 1 was evaluated in patients with chronic hepatitis C (CHCV) using a double-blind, randomised placebo controlled protocol. Treatment involved 5 tablets tds for 6 months with monthly assessment by a hepatologist and traditional Chinese medicine specialist. 58 patients were assessed, 43 randomised to treatment and 40 completed therapy. Results Treated Group Placebo Group (n) Age (yrs) 10; 40.4 20; 40.9 Male % 59.1 59.1 Duration of HCV (mths) 92 83 Alcohol g/d; Past interferon 20; 20; Initial/final ALT 120/82 102/102 Treatment with the composition of the present invention resulted in a significant (p<0.03) fall in ALT whereas treatment with placebo did not (Wilcoxon matched pairs signed- rank test for non-parametric date). 4 patients in the treatment group normalised their ALT but relapsed on cessation of drug. Treatment had no effect on ALP, Haemoglobin, WCC and platelets. The results ofthe study demonstrate that the composition was capable of modifying disease activity in CHCV. Further studies of the treatment on HCV-RNA and histological changes are supported by these preliminary results. A person skilled in the art will understand that the therapeutic effects ofthe composition result from a plurality of active agents in each herb which when combined, act synergistically to enhance efficacy. It will also be understood that compositions comprising all or a selection of such active agents, preferably in pure form, are also contemplated herein, as are liquid formulations of the composition and formulations which are suitable for slow release administration. Thus it will be understood that the compositions of the invention can be administered orally, intravenously, subcutaneously, topically or by other known means. The compositions are effective in treating hepatic disorders generally, irrespective of their aetiology since the compositions act at least in part to improve liver function and microcirculation. The compositions may also exert their effect prophylactically, by preventing or minimising the adverse effects of viral infection or the action of other agents which cause liver dysfunction. Therefore, the treatment of hepatic disorders caused by viral infection, autoimmune reactions, drug intake and the like are contemplated herein. The invention may be embodied in various other forms which are understood by those skilled in the art.

Claims: CLAIMS :- 1. A composition comprising the herbs Salvia miltiorrhiza and Polyporus umbellatus, or extracts thereof. 2. A composition according to claim 1, further comprising at least one of the herbs selected from Curcumae longa, Astragalus membranaceus, Loranthus parasiticus and Polygonum cuspidatum, or extracts thereof. 3. A composition according to claim 1 or claim 2, further comprising at least one of the herbs selected from Poria cocos, Artemisia capillaris, Taraxacum mongolicum, Paeonia lactiflora, Panax pseudoginseng, Bupleurem falcatium, Crataegus pinnatifida, Glechoma longituba, Codonopsis pilosula, Lycium barbarum, Zizyphus jujuba, Gentiana manshurica, and Glycyrrhiza uralensis or extracts thereof. 4. A composition comprising the herbs Salvia miltiorrhiza, Polyporus umbellatus, Poria cocos, Artemisia capillaris, Taraxacum mongolicum, Paeonia lactiflora, Panax pseudoginseng, Bupleurem falcatium, Crataegus pinnatifida, Curcumae longa, Glechoma longituba, Astragalus membranaceus, Codonopsis pilosula, Loranthus parasiticus, Lycium barbarum, Polygonum cuspidatum, Zizyphus jujuba, Gentiana manshurica and Glycyrrhiza uralensis, or extracts thereof. 5. A composition according to any one of claims 1 to 4, wherein the composition comprises herbal extracts in the form of a tablet. 6. A composition according to any one of claims 1 to 4, wherein the composition comprises herbal extracts in the form of a liquid. 7. A composition according to any one of claims 1 to 6, wherein Salvia miltiorrhiza and Polyporus umbellatus each comprise from 6 to 30% ofthe total weight ofthe composition. 8. A composition according to any one of claims 1 to 7, wherein the part of the herb used in the composition is selected from the group consisting of the root, the stem, the fruit, the tuber and the whole plant, or combinations thereof. 9. A method of preparing a composition according to any one of claims 1 to 8, comprising the steps of: a. mixing cut, ground or powdered herbs; b. boiling the mixture to obtain a concentrated liquor, and c. collecting the concentrated liquor. 10. A method according to claim 9, further comprising the steps of concentrating said liquor into a paste and formulating said paste into tablets. 11. A method of treating hepatic disorders comprising the administration to a patient requiring such treatment a composition according to any one of claims 1 to 8. 12. A method according to claim 11, wherein the hepatic disorder is caused by a virus infection. 13. A method according to claim 12, wherein the virus infection is a hepatitis C virus infection. 14. A method according to claim 12 or claim 13, wherein the infection is in the from of chronic hepatitis. 15. A method according to claim 11 , wherein the hepatic disorder is non-viral hepatitis 16. A method according to any one of claims 11 to 15, wherein the hepatic disorder is associated with an abnormality in hepatic microcirculation. 17. A method according to any one of claims 11 to 16, wherein the hepatic disorder is associated with cirrhosis. 18. A method according to any one of claims 11 to 17, where the composition is administered orally. 19. A method according to any one of claims 11 to 17, where the composition is administered parenterally. 20. A method according to any one of claim 11 to 19, wherein the treatment is therapeutic. 21. A method according to any one of claim 11 to 20, wherein the treatment is prophylactic.

Inventors: YANG YI FAN, YANG, YI, FAN
Applicants: CATHAY HERBAL LAB PTY LTD, YANG YI FAN, CATHAY HERBAL LABORATORIES PTY. LTD., YANG, YI, FAN
Application year: 1996
Main classification: A61K35
IPC codes: A61K9, A61K36