Preparation method of high-purity natural ursodesoxycholic acid and application thereof in medicament

A technology of ursodeoxycholic acid and tauroursodeoxycholic acid, applied in the field of medicine and biology, can solve the problems of difficult control of reaction by-products and low reaction yield

A technology of ursodeoxycholic acid and tauroursodeoxycholic acid, applied in the field of medicine and biology, can solve the problems of difficult control of reaction by-products and low reaction yield

CN101870718AInactive Publication Date: 2010-10-27重庆寰瑞生物技术有限公司
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  • Preparation method of high-purity natural ursodesoxycholic acid and application thereof in medicament

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Embodiment Construction

[0013] Now illustrate the method of the present invention with a preferred process condition example:

[0014] Get 1 kg of bear bile powder decoction pieces, stir and dissolve with 10 kg of 50% methanol solution, add sodium acetate to a final concentration of 25 mmol / L, adjust the acidity to 5.8 with acetic acid, filter to obtain 10.6 liters of bear bile powder decoction pieces solution.

[0015] The CM Sephrose Fast Flow cation chromatography medium is used to fill a glass chromatography column with a column size of 10cm×80cm and a packing height of 60cm. Prepare equilibration buffer: 50% methanol, 25mmol / L acetic acid-sodium acetate buffer, pH 5.8. Equilibrate 3 times the column volume with equilibration buffer, load the sample solution of bear bile powder decoction pieces, and then equilibrate 3 times the column volume after loading the sample. Prepare elution buffer I: 50% methanol, 25mmol / L acetic acid-sodium acetate buffer, 100mmol / L sodium chloride, pH 5.8. Elute with...

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Abstract

The invention belongs to the technical field of medical biology, in particular to a preparation method of high-purity natural ursodesoxycholic acid. The high-purity natural ursodesoxycholic acid is obtained by separating and purifying bear gall powder prepared from a manual drained bear gall, and the high performance liquid chromatography purity is not lower than 98 percent. The preparation method comprises the following steps of: firstly, separating and purifying by applying a cation exchange medium to prepare tauroursodeoxycholic acid with purity not lower than 90 percent; and then thoroughly hydrolyzing the tauroursodeoxycholic acid into ursodesoxycholic acid and taurine in the presence of alkali and separating and purifying by applying a silica gel adsorption chromatography technology to prepare the ursodesoxycholic acid with purity not lower than 98 percent. The natural ursodesoxycholic acid prepared by the invention has the effects on treating primary biliary cirrhosis and primary sclerosing cholangitis.

Description

technical field [0001] The invention belongs to the technical field of medicine and biology, and in particular relates to a preparation method of high-purity natural ursodeoxycholic acid and its application in medicine. Background technique [0002] Ursodeoxycholic acid (UDCA) is an active ingredient of bear bile, a rare medicine, which has the functions of clearing away heat, calming the liver, and improving eyesight. It has a unique curative effect on cholesterol gallstones. The preparation method of existing patent or bibliography UDCA at home and abroad mainly contains three aspects, the one is that the bear bile powder that natural bear bile or artificial drainage bear bile is prepared is that raw material extracts and refines (referring to literature: Shi Lixia etc., drainage bear bile Comparison of active ingredient content before and after powder refining, Chinese Materia Medica. 2000, 23(6): 334; Shi Lixia et al., Development and Clinical Application of Bear Bile I...

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Application Information

Patent Timeline
27 Oct 2010
Publication
CN101870718A
IPC
C07J9/00; A61K31/575; A61P1/16
Inventors
王建; 张金魁