溶媒残留对阿奇霉素胶囊溶出度的影响

Effect of Residual Solvent on Dissolution of Azithromycine Capsules

目的:考察阿奇霉素原料中的溶媒残留对阿奇霉素胶囊的体外溶出度的影响。方法:采用中国药典2005年版二部溶出度测定方法(附录XC,第二法),对不同溶媒残留的阿奇霉素胶囊样品进行的溶出度的测定,对比其溶出效果。结果:阿奇霉素原料丙酮残留高对阿奇霉素胶囊溶出度的影响较大,阿奇霉素原料丙酮残留低对阿奇霉素胶囊溶出度影响小,阿奇霉素原料丙酮残留的高低是影响阿奇霉素胶囊溶出度的重要因素之一。结论:可通过生产工艺控制阿奇霉素原料中丙酮的残留,进而使阿奇霉素胶囊的溶出度得以控制。

Objective： To observe the effects of residual solvent on in - vitro dissolution of azithremycine capsules. Methods：According to appendix XC Ⅱ of Chinese Pharmacopoeia 2005 edition Vol Ⅱ ,determine the dissolution of azithromycine capsules from two groups of different residual solvent. Results： the content of residual acetone is one of the most important factor to influence the dissolution of azithmmycine capsules. The higher content of residual acetone has greater influence than the lower content of residual acetone. Conclusion：Through controlling the productive technology of residual acetone of azithromycine capsules,The dissolution of azithromycine capsules will be controled.