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• 评价技术与方法 • 上一篇    下一篇

国产桂利嗪片的溶出曲线考察

陈承贵,梁智渊,庞发根,李玉兰,王铁杰   

  1. 深圳市药品检验研究院,深圳市药品检验研究院,深圳市药品检验研究院,深圳市药品检验研究院,深圳市药品检验研究院
  • 收稿日期:2018-06-02 修回日期:2018-07-15 出版日期:2018-08-25 发布日期:2018-08-25
  • 基金资助:
    2017年国家药品评价性抽验研究项目

Investigation on Dissolution Curve of Domestic Cinnarizine Tablets

chen chengggui,,, and   

  1. Shenzhen Institute for Drug Control,Shenzhen Institute for Drug Control,Shenzhen Institute for Drug Control,,Shenzhen Institute for Drug Control
  • Received:2018-06-02 Revised:2018-07-15 Online:2018-08-25 Published:2018-08-25

摘要: 目的:比较国产桂利嗪片在4种溶出介质中的溶出曲线,评价原研制剂与仿制制剂的溶出行为。方法:采用篮法、转速100 r·min-1,分别以pH 1.0盐酸溶液、pH 4.0醋酸盐溶液、pH 6.8磷酸盐缓冲液、水为溶出介质,以高效液相色谱法测定溶出曲线,采用AV法对溶出曲线的相似度进行评价。结果:在pH 1.0盐酸溶液溶出介质下,8家企业产品溶出曲线与原研产品的溶出曲线相似,5家企业产品与原研样品的溶出曲线不相似;在pH 4.0醋酸盐溶液溶出介质下,有3家企业产品与原研产品的溶出行为基本相似;在另外2种溶出介质下原研制剂与国产制剂均无溶出行为。结论:多条国产桂利嗪片溶出曲线与原研片剂不相似,各企业产品质量存在差异,亟待提高处方与工艺。

Abstract: Objective: To compare the dissolution profiles of domestic cinnarizine tablets in four different dissolution media and evalutate the quality difference between the original and generic drugs. Methods: On the basis of the rotating basket method with the rotate speed at 100 r·min-1, the dissolution testing of tablets in various media at different pH values were performed by using high performance liquid chromatography. The similarities of dissolution curves were analyzed by the AV method. Results:Under the dissolution medium pH 1.0 hydrochloric acid solution, eight enterprise product dissolution curvesare similar to branded products dissolution curve, 5 companies products dissolution curve are not similar with the original sample. Under the dissolution medium pH 4.0 acetic acid salt solution, there are 3 companies products similar to branded products the dissolution behavior of basic. In the other two kinds of dissolution medium without dissolution behavior.Conclusion: Most manufactures cannot produce high-quality generic drugs with similar dissolution profiles to the original drugs. There are differences among the quality of domestic cinnarizine tablets from different manufactures which need to be improved.