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• 评价技术与方法 • 上一篇    下一篇

不同厂家双嘧达莫片的溶出曲线比较研究

田洁,郝爱鱼,赵丽元,邹亮,刘英慧,丁红雨   

  1. 大连市药品检验所,大连市药品检验所,大连市药品检验所,大连市药品检验所,大连市药品检验所,大连市药品检验所
  • 收稿日期:2014-12-29 修回日期:2015-04-08 出版日期:2015-04-25 发布日期:2015-04-25

Comparative Studies on Dissolution Profiles of Dipyridamole Tablets from Different Pharmaceutical Manufacturers

郝爱鱼,赵丽元,邹亮,刘英慧 and 丁红雨   

  1. DaLian Institute for Drug Control,Dalian Institute for Drug Control,Dalian Institute for Drug Control,,,
  • Received:2014-12-29 Revised:2015-04-08 Online:2015-04-25 Published:2015-04-25

摘要: 目的:比较国产双嘧达莫片和原研制剂的溶出曲线相似性,为全面评价国产双嘧达莫片的质量提供参考与依据。方法:采用《中国药典》2010年版二部标准,测定了国内6家企业生产的制剂以及原研制剂的溶出度及溶出曲线,并以国内制剂为受试制剂,原研制剂为参比制剂,采用差异因子f1和相似因子f2比较其溶出曲线的相似性。结果:按照《中国药典》2010年版标准,受试制剂与参比制剂的溶出度均符合规定;采用相似因子法评价,受试制剂批内溶出曲线差异较大,受试制剂与原研制剂相比也无相似性。结论:相似因子评价法能够有效地反映和控制产品的内在质量,指导厂家改进生产工艺,提高产品质量。

Abstract: Objective: To compare the similarity of dissolution curves of dipyridamole tablets from the original drug enterprise and domestic enterprises, and provide the basis for a comprehensive evaluation of the quality of domestic dipyridamole tablets. Methods: The dissolusion and dissolution curves of the original drug enterprise and 6 domestic enterprises were ditermined on the basis of the “Chinese Pharmacopoeia” 2010 edition, the similarity was compared by the calculation of f1 and f2 factors using the product from the original enterprise as the reference preparation, and the domestic products as the test preparation. Results: Accordance with the standard of the “Chinese Pharmacopoeia” 2010 edition,the dissolution of the reference preparation and the test preparation comply with the requirements;Similarity factor was evaluated,the disslution curves of the same batch of test preparation exhibited obvious differences, and there was no similarity between the test preparation and the reference preparation by the methods of f1 and f2 factors. Conclusion: The similarity factor evaluation method can effectively reflect and control the intrinsic quality of the product, instruct manufacturers to improve production processes and product quality.