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阿莫西林胶囊溶出曲线相似性评价

熊亚群.,李兰,刘雁鸣   

  1. 中南大学药学院;湖南药用辅料检验检测中心,湖南药用辅料检验检测中心,湖南药用辅料检验检测中心
  • 收稿日期:2014-12-12 修回日期:2015-03-03 出版日期:2015-04-25 发布日期:2015-04-25
  • 基金资助:

Comparability Evaluation of Dissolution Curve of Amoxicillin Capsules

  1. School of Pharmacy,Central South University;Hunan Pharmaceutical Excipients Testing and Inspection Center,Hunan Pharmaceutical Excipients Testing and Inspection Center,
  • Received:2014-12-12 Revised:2015-03-03 Online:2015-04-25 Published:2015-04-25

摘要: 目的:考察4家药厂生产的阿莫西林胶囊在4种溶出介质中的溶出情况,并对溶出曲线相似性进行评价。方法:分别以水、pH 1.2 盐酸溶液、pH 4.0 醋酸盐缓冲液及pH 6.8 磷酸盐缓冲液为溶出介质,按《中华人民共和国药典》(2010年版)阿莫西林胶囊项下方法进行溶出曲线测定。选择非模型依赖法f2相似因子法和模型依赖法weibull分布模型评价溶出曲线的相似性。结果: A、B、C样品均为国产样品,其T50、Td值相差小,溶出曲线相似;D样品为ICH成员国进口样品,其T50、Td值约为A、B、C样品的2倍,与A、B、C样品累计溶出曲线的相似因子均小于50,溶出曲线存在显著差异。结论:f2相似因子法和weibull分布模型法二者互为补充,适用于固体制剂体外溶出曲线相似性评价。

Abstract: Objective:To investigate the dissolution of amoxicillin capsules which came from four pharmaceutical companies in four kind of dissolution media, and to evaluate the comparability of dissolution curves. Methods:According to ChP 2010, water, pH 1.2 hydrochloric acid solution,pH 4.0 acetate buffer solution and pH 6.8 phosphate buffer solution were respectively used to determine the accumulative dissolution of the samples. The model independent method -f2 similarity factor method and model dependent method -weibull’s distribution model were selected to evaluate the comparability of dissolution curves. Results: A, B, and C came from domestic pharmaceutical companies, their value of T50 and Td were very close and their dissolution curves were similar; D came from pharmaceutical company of ICH members, its value of T50,Td double than that of A, B, and C, in addition, the dissolution curve was significantly different from that of A, B, and C,the similarity factors were all less than 50. Dissolution:f2 similarity factor and weibull’s distribution model method complement each other. both of them were suitable to evaluate the dissolution curve similarity of solid preparation.