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Tanshinone II A sulfonate, preparation method, and applications thereof

A technology of sodium sulfonate and tanshinone, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, steroidal compounds, etc., can solve problems such as difficult large-scale production, low product safety, and difficult operation, and achieve easy operation , Reduce production cost, improve the effect of yield

Inactive Publication Date: 2013-12-18
SPH NO 1 BIOCHEM & PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The technical problem to be solved by the present invention is to provide a kind of tanshinone IIA sulfonic acid in order to overcome the defects of the existing preparation method of sodium tanshinone IIA sulfonate, such as difficult operation, not easy to large-scale production, or low product safety. Sodium, its preparation method and use

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  • Tanshinone II A sulfonate, preparation method, and applications thereof

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Experimental program
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Effect test

Embodiment 1

[0045] In a 5L constant temperature bath, add 50g of the crude product of tanshinone IIA sodium sulfonate (produced by Shanghai First Biochemical Pharmaceutical Co., Ltd.), dissolve it with 3L of 80% (v / v) methanol solution at a temperature of 60°C, and stir until all dissolve. Add 25g of activated carbon (Shanghai Activated Carbon Factory Co., Ltd.), stir for 1 hour, and suction filter while it is hot. The filtrate is concentrated to 60% under reduced pressure (relative pressure -0.09MPa) at 35°C, and the concentrated solution is placed in a freezer at -3°C for refrigerated analysis. crystallized, frozen for 20 hours, suction filtered to dryness, and the filter cake was put into a vacuum oven at 30° C. to dry for 24 hours to obtain 47 g of pure tanshinone IIA sodium sulfonate, with a yield of 94%. After HPLC detection, the calculated content of the dry product was 98.9%; organic solvent residues detected by gas chromatography, methanol was 0.1%, and methylene chloride was not...

Embodiment 2

[0047] In a 5L constant temperature bath, add 50g of the crude product of tanshinone IIA sodium sulfonate (produced by Shanghai First Biochemical Pharmaceutical Co., Ltd.), dissolve it with 3L of 80% (v / v) methanol solution at a temperature of 60°C, and stir until all dissolve. Add 25g of diatomaceous earth, stir for 1.5 hours, and suction filter while it is hot. The filtrate is concentrated to 60% under reduced pressure (relative pressure-0.1MPa) at 30°C. Suction filtration to dryness, the filter cake was put into a vacuum drying oven at 30°C and dried for 24 hours to obtain 46 g of pure tanshinone IIA sodium sulfonate, with a yield of 92%. The calculated content of the dried product was 99.4% through HPLC detection; The solvent remained, methanol was 0.05%, and dichloromethane was not detected.

Embodiment 3

[0049] In a 5L constant temperature bath, add 50g of crude sodium tanshinone IIA sulfonate (produced by Shanghai First Biochemical Pharmaceutical Co., Ltd.), dissolve with 3.5L of 90% (v / v) methanol solution, the temperature is 55% ℃, stir until completely dissolved. Add 15g of activated carbon (Shanghai Activated Carbon Factory Co., Ltd.), stir for 1 hour, and suction filter while it is hot. The filtrate is concentrated to 45% under reduced pressure (relative pressure -0.09MPa) at 30°C, and the concentrate is placed in a freezer at 7°C for freezing and crystallization. , frozen for 20 hours, suction filtered until dry, and the filter cake was dried in a vacuum oven at 30°C for 20 hours to obtain 46 g of pure tanshinone IIA sodium sulfonate, with a yield of 92%. The calculated content of the dry product was 99.3% by HPLC detection. %; gas chromatography detection of organic solvent residues, methanol was 0.08%, dichloromethane was not detected.

[0050] The above-mentioned fi...

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Abstract

The invention discloses a tanshinone II A sulfonate, and a preparation method thereof. The preparation method comprises following steps: (1) dissolving crude tanshinone II A sulfonate in a methanol water solution with a concentration of 15% to 95% and a temperature of 50 DEG C to 80 DEG C, carrying out stirring absorption with an absorbing agent, controlling the solution temperature in the range of 50 DEG C to 80 DEG C during absorption and the stirring time in the range of 0.5 to 1.5 hours, and filtering when the solution is still hot; (2) subjecting the solution obtained in the step (1) to a reduced pressure condensation treatment until the volume of the condensed solution is 40% to 60% of the original volume; (3) subjecting the solution obtained in the step (2) to a cooling treatment to separate out crystals, and controlling the devitrification temperature in the range of minus 5 DEG C to 10 DEG C, and the devitrification time in the range of 5 to 20 hours; (4) drying the crystals obtained in the step (3). The invention also discloses applications of the tanshinone II A sulfonate. The preparation method can prominently improve the quality of tanshinone II A sulfonate, and prominently reduce clinical potential risk of injections made of tanshinone II A sulfonate.

Description

technical field [0001] The present invention specifically relates to a kind of sodium tanshinone IIA sulfonate and its preparation method and application. Background technique [0002] The traditional Chinese medicine Salvia miltiorrhiza is the dried root and rhizome of Salvia miltiorrhiza, which is a plant of the Labiatae family. It is clinically used for dysmenorrhea, irregular menstruation, tingling pain in the chest and abdomen, and restlessness and insomnia. The chemical components of Danshen are mainly divided into water-soluble phenolic acid compounds and fat-soluble tanshinone compounds. The medical value of the two types of compounds has been confirmed by a large number of medical literature and clinical practice. Among them, the typical representative of phenolic acid compounds is salvianolic acid B, which is used to treat myocardial damage, myocardial infarction, angina pectoris and other diseases; the typical representative of tanshinone compounds is sodium tansh...

Claims

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Application Information

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IPC IPC(8): C07J73/00A61K31/58A61P9/10
Inventor 黄臻辉刘伟张晨亮丁金国
Owner SPH NO 1 BIOCHEM & PHARMA CO LTD
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