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Refining process of triamcinolone acetonide raw medicine

A raw material drug and process technology, applied in the technical field of triamcinolone acetonide raw material drug refining, to achieve the effect of high content, high yield and stable quality

Active Publication Date: 2009-01-21
天津太平洋化学制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can completely solve the quality problems in the existing process and make the product fully meet the latest requirements of the Chinese Pharmacopoeia, which cannot be achieved by various previous methods

Method used

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  • Refining process of triamcinolone acetonide raw medicine

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Effect test

Embodiment 1

[0018] Embodiment 1: a kind of process of triamcinolone acetonide crude drug refining, adopts mixed organic solvent recrystallization to refine, and it comprises the following steps:

[0019] 1), at 30°C, put 30kg of triamcinolone acetonide crude product into 300kg of chloroform and 300kg of methanol mixed solvent, heat to reflux at 60°C, stir and react for 1.5 hours, after the reaction is completed, cool to below 0°C, shake off and dry to obtain koji Acetonide chloroform-methanol primary refinement 28.5kg, content 95.1%;

[0020] 2), at 20°C, repeat step 1) with 28.5kg of the primary refined product, put it into 285kg of chloroform and 285kg of methanol mixed solvent, heat to 70°C and reflux, stir and react for 2 hours, after the reaction is completed, cool, filter, and dry to obtain Triamcinolone acetonide chloroform-methanol secondary refinement 27.1kg, content 96.2%;

[0021] 3), at 50°C, put 27.1kg of triamcinolone acetonide chloroform-methanol secondary refined product ...

Embodiment 2

[0022] Embodiment 2: a kind of process of triamcinolone acetonide crude drug refining, adopts mixed organic solvent recrystallization to refine, and it comprises the following steps:

[0023] 1), at 30°C, put 30kg of crude triamcinolone acetonide into 700kg of chloroform and 100kg of methanol mixed solvent, heat to reflux at 56°C, stir and react for 1.5 hours. Acetonide chloroform-methanol primary refinement 28.8kg, content 95.0%;

[0024] 2), at 20°C, repeat step 1) with 28.8kg of primary refined product, put it into 672kg of chloroform and 96kg of methanol mixed solvent, heat to 56°C and reflux, stir and react for 2 hours, after the reaction is completed, cool, filter, and dry to obtain Triamcinolone acetonide chloroform-methanol secondary refinement 27.7kg, content 96.0%;

[0025] 3), at 50°C, put 27.7kg of triamcinolone acetonide chloroform-methanol secondary refinement into 1108kg of ethanol with a content of 80%, heat to reflux at 80°C, stir and react for 2.5 hours, aft...

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Abstract

The invention relates to a technology for refining a raw material drug of Triamcinolone. The method comprises the following steps that refining is carried out through recrystallization with a mixed organic solvent, wherein the raw Triamcinolone is added into the mixed solvent of chloroform and carbinol, heated to 50 to 70 DEG C, then a circumfluence under mixing is carried out, and the refined product undergoes the procedures until the content of Triamcinolone exceeds 96 percent, then the refined product undergoes heating circumfluence in ethanol for 2-3 hours, at a temperature of between 70 and 90 DEG C, is cooled down to a temperature below 0 DEG C, filtered by centrifuge, and then dried. The obtained final product is proved completely qualified according to China Pharmacopoeia. The invention can overcome the disadvantages of the prior refining art, and the final product produced by the method has the advantages of stable quality, high content, low impurities, and high yielding rate.

Description

technical field [0001] The invention belongs to a preparation process of medicine triamcinolone acetonide, in particular to a process for refining triamcinolone acetonide crude drug. Background technique [0002] Triamcinolone acetonide is a glucocorticoid with anti-inflammatory, antipruritic and antiallergic effects. It is an old product that has been used for many years, but recently my country has begun to comprehensively regulate the organic solvent residues of its raw materials according to the Pharmacopoeia standards. [0003] The traditional refining method of triamcinolone acetonide crude drug is to use the crude product of triamcinolone acetonide as a raw material, and refine it with a mixed organic solvent. After the reaction is completed, the reaction solution is cooled, filtered and dried to obtain crystals. But this method can only improve the purity of the triamcinolone acetonide bulk drug, but can not reduce the corresponding organic volatile impurities, whic...

Claims

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Application Information

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IPC IPC(8): C07J71/00A61P29/00A61P37/08
Inventor 赵有杰刘彩田
Owner 天津太平洋化学制药有限公司
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