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Synthesis method of crospovidone

A technology for cross-linked povidone and a synthesis method, applied in the field of pharmaceutical excipients, can solve the problem of low purity of crospovidone, achieve the effects of moderate apparent density, reduced generation of impurities, and easy operation

Inactive Publication Date: 2016-08-31
贵州省欣紫鸿药用辅料有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The preparation of cross-linked povidone usually adopts the self-crosslinking polymerization method of N-vinylpyrrolidone. In this method, in the presence of alkali metal hydroxide, N-vinylpyrrolidone will react with each other when heated above 100 ° C, and self-crosslinking Get crospovidone, but the purity of crospovidone is not high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Add 25g of anhydrous sodium sulfate and 25g of anhydrous disodium hydrogen phosphate into 500ml of purified water to dissolve in a water bath, then add 5g of polyvinylpyrrolidone K30, stir and dissolve, add 500ml of N-vinylpyrrolidone and fill it with nitrogen as a reaction protection gas. When the temperature rises to 50°C, 15ml of hydrogen peroxide solution (31% by mass) is continuously added dropwise, and 20ml of divinyl benzo is added to carry out the polymerization reaction in time, and the reaction is stopped after 3 hours to obtain the product.

Embodiment 2

[0023] Add 25g of anhydrous sodium sulfate and 30g of anhydrous disodium hydrogen phosphate into 1100ml of purified water to dissolve in a water bath, then add 10g of polyvinylpyrrolidone K30, stir and dissolve, add 550ml of N-vinylpyrrolidone and fill it with nitrogen as a reaction protection gas. When the temperature rose to 60°C, 22ml of hydrogen peroxide solution (33% by mass) was continuously added dropwise, and 12.5ml of divinyl benzo was added to carry out the polymerization reaction by time, and the reaction was stopped after 5 hours to obtain the product.

Embodiment 3

[0025] Add 25g of anhydrous sodium sulfate and 35g of anhydrous disodium hydrogen phosphate into 1800ml of purified water to dissolve in a water bath, then add 15g of polyvinylpyrrolidone K30, stir and dissolve, add 720ml of N-vinylpyrrolidone and fill it with nitrogen as a reaction protection gas. When the temperature rises to 80°C, 36ml of hydrogen peroxide solution (35% by mass) is continuously added dropwise, and 43.2ml of divinyl benzo is added to carry out the polymerization reaction in time, and the reaction is stopped after 9.5h to obtain the product.

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Abstract

The invention relates to a synthesis method and especially relates to a synthesis method of crospovidone and belongs to the field of medicinal auxiliary materials. The synthesis method includes the steps of: dissolving anhydrous sodium sulfate, anhydrous disodium hydrogen phosphate and polyvinylpyrrolidone K30 in purified water in a water-bath heating manner; adding N-vinyl pyrrolidone and filling the reaction system with nitrogen gas; and when the temperature of the solution is increased to 50-80 DEG C, adding a hydrogen peroxide solution and divinylbenzene to perform a polymerization reaction for 3-9.5 h. The synthesis method employs safe and cheap hydrogen peroxide as a catalyst, wherein the polymerization is initiated by means of free radicals generated during a redox reduction of the hydrogen peroxide which is then decomposed into water and oxygen, so that the method is safe and toxic-free.

Description

technical field [0001] The invention relates to a synthesis method, in particular to a synthesis method of crospovidone, and belongs to the technical field of pharmaceutical excipients. Background technique [0002] Cross-linked povidone is a water-insoluble homopolymer synthesized and cross-linked by N-vinylpyrrolidone, and its molecular formula is (C6H9NO)n, where n represents the average number of 1-vinyl-2-pyrrolidone chain members. Calculated on the basis of anhydrous matter, the nitrogen (N) content should be 11.0% to 12.8%. [0003] Crospovidone is mainly used in the pharmaceutical industry. As one of the three new pharmaceutical excipients advocated internationally, it is mainly used as a disintegrating agent and filler in medicines, and a super disintegrating agent in tablets. Improve the release rate of active ingredients in tablets, capsules and pills. Insoluble crospovidone is a swelling polymer with a wide variety of applications. Because they can decompose t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08F271/02C08F226/10C08F212/36
CPCC08F271/02
Inventor 王兴安沈惠母泽波母瑞文民印卫东
Owner 贵州省欣紫鸿药用辅料有限公司
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