WO2008090410A4

WO2008090410A4 - Cinnamomi and poria composition and uses thereof

Info

Publication number: WO2008090410A4
Application number: PCT/IB2007/004483
Authority: WO
Inventors: Wei Xiao; Xiang Ling Dai; Ya Ling; Zhen Zhong Wang; Yu An Bi; Zheng Kuan Wang
Original assignee: Jiangsu Kanion Pharmaceuticals; Wei Xiao; Xiang Ling Dai; Ya Ling; Zhen Zhong Wang; Yu An Bi; Zheng Kuan Wang
Priority date: 2006-10-18
Filing date: 2007-10-17
Publication date: 2009-01-22
Also published as: HUE035045T2; CA2659442A1; EP2073825A4; JP5328656B2; CN101495129A; JP2010506899A; CA2659442C; US8067040B2; KR101545356B1; WO2008090410A2; EP2073825B1; EP2073825A2; KR20090067135A; MY164475A; US20100183660A1; CN101495129B; WO2008090410A3

Abstract

a composition comprising Chinese herbal medicines Ramulus cinnamoni and Poria cocos is provided, wherein the composition is defined by a fingerprint profile obtained from an improved chromatographic method. Various uses of such compositions are also provided.

Claims

received by the International Bureau on 11 November 2008

15. (New) A method of preparing granules comprising a composition of Ramulus cinnamomi and Poria cocas, comprising the steps of:

(a) Grinding Poria into fine powder to give Poria powder;

(b) Extracting Cortex moutan by steam distillation to give a Paeonol extract;

(C) Extracting the extracted raw material from step (b) with ethanol to give Extract I, and then extracting said raw material again with hot water to give Extract II;

(d) Extracting Ramulus cinnamomi by steam distillation to give a volatile oil;

(e) Extracting the extracted material from step (d) with ethanol to give Extract III, and then extracting said raw material again with hot water to give Extract IV;

(f) Extracting Radix paeoniae alba. Semen perε±cae, and Poria with ethanol to give Extract V, and then with hot water to give Extract VI;

(g) Combining Extracts I, III and V, and removing all ethanol to give Liquid A;

(h) Combining Extracts II, IV and VI, and concentrating the combined extracts to give Liquid B;

(i) Combining Liquids A and B, and concentrating the liquids to give a Semisolid Extract with a relative density equal to 1.15-1.35 (60-90°C),-

(j) Dissolving the Paeonol extract from step (b) in ethanol, and adding the solution to an aqueous solution of β-cyclodextrin, wherein the mixture is grinded and dried to give Inclusion Substance I;

(k) Mixing the volatile oil from Step (d) with β- cyclodextrin in ethanol, wherein the mixture is grinded and dried to give Inclusion Substance II;

(1) Mixing the Poria Powder from step (a) with the Semisolid Extract from step (i), wherein the mixture is dried and grinded into fine powders; (m) Mixing the fine powders from step (1) with Inclusion Substances I and II, adding ethanol to the mixture to make a dough-like mass, and passing the wet material through a sieve to obtain granules; and

(n) Drying said granules, and passing the dried granules through the sieve again to give final granules of Ramulus cinnamomi and Poria cαcos .

16. (New) The method of claim 15, wherein the composition further comprise Paeoniflorin and Paeonol.

17. (New) The method of claim 16, wherein the Paeoniflorin is present at 1-26-1.90% and the Paeonol Ls present at 0.71- 1.07%.

18. (New) The method of any of claims 15-17, wherein the composition is formulated into a pill, capsule, granules, tablet, suspension or syrup.

19. (New) The method of claim 18, wherein the composition formulated as a pill, capsule, granules, tablet, suspension or syrup is used to treat a disease or disorder selected from a group consisting of primary dysmenorrheal , secondary dysmenorrheal, dysfunctional uterine bleeding, chronic pelvic inflammations, and small intramural hysteromyotna .

20. (New) The method of claim 18 or 19, wherein the composition formulated as a pill, capsule, granules, tablet, suspension or syrup is administered orally, rectally, parenterally, intra-vaginally, intra-peritoneally, topically, or as an oral or nasal spray.

21. A method of analyzing the composition of claim 15, comprising the steps of:

a) extracting the composition with an appropriate organic solvent; and b) performing chromatographic analysis;

wherein the analysis produces 12 peaks.

22. The method of claim 21, wherein the organic solvent is methanol.

23. The method of claim 21 or 22, wherein Paeoniflorin is used as a standard in the chromatographic analysis.

24. The method of any of claims 21-23, wherein the chromatographic analysis is high performance liquid chromatography (HPLC) .

25. The method of any of claims 21-24, wherein the relative peak area ranges for peaks 1, 8, 9, and 12 as compared to Paeoniflσrin are 0.25-0.89, 0.69-1.5, 0.3-0.85 and 1.56- 3.06, respectively.

26. The method of any of claims 21-25, wherein the relative retention time ranges for peaks 1-12 as compared to Paeoniflorin are 0.209-0.314, 0.456-0.683, 0.733-0.999, 0.871-1.306, 0.921-1.382, 0.968-1.451, 1.009-1.514, 1.058- 1.587_r 1.152-1.728, 1.69-2.536, 1.771-2.657 and 1.943- 2.915, respectively.

27. Use of the composition produced by the method of any of claims 15-17 in the manufacture of medicament for treating a disease or disorder selected from a group consisting of primary dysmenorrheal, secondary dysmenorrheal, dysfunctional uterine bleeding, chronic pelvic inflammations, and small intramural hysteromyoma.

28. The use of claim 27, wherein the composition is formulated into a pill, capsule, granules, tablet, suspension or syrup.

29. The use of claim 28, wherein the composition formulated as a pill, capsule, granules, tablet, suspension or syrup is administered orally, rectally, parenterally, intra- vaginally, intra-peritoneally, topically, or as an oral or nasal spray.