• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2021, Vol. 38 ›› Issue (2): 156-160.

• 评价技术与方法 • 上一篇    下一篇

市售阿奇霉素片体外溶出行为比较研究

王燕妮1, 张泽波2   

  1. 1. 泰州市药品检验院, 江苏 泰州 225300;
    2. 泰州市医药科技成果转化服务中心, 江苏 泰州 225300
  • 收稿日期:2020-12-09 修回日期:2021-02-23 出版日期:2021-04-28 发布日期:2021-04-28

Comparative Study on Dissolution Behavior of Azithromycin Tablets in Vitro

WANG Yan-ni1, ZHANG Ze-bo2   

  1. 1. Taizhou Institute for Drug Control, Jiangsu Taizhou 225300, China;
    2. Taizhou Pharmaceutical Technology Transfer Center, Jiangsu Taizhou 225300, China
  • Received:2020-12-09 Revised:2021-02-23 Online:2021-04-28 Published:2021-04-28

摘要: 目的: 比较研究已通过和未通过仿制药质量和疗效一致性评价的市售阿奇霉素片与原研制剂的体外溶出行为差异。方法:参考日本PMDA阿奇霉素片IF文件中溶出曲线测定方法和我国相关指导原则确定溶出参数,HPLC测定溶出量,绘制溶出曲线,采用f2相似因子法评价不同溶出介质中三厂家阿奇霉素片的溶出曲线相似性;参照《中国药典》中的方法评价各溶出度是否符合限度标准。结果: A、B、S三厂家阿奇霉素片以pH 1.2、pH 6.8、pH 4.5和水为溶出介质的四条溶出曲线,S为参比制剂,A的四条曲线f2值均>50,四条溶出曲线均相似;B前两条曲线f2值>50,后两条由于批内RSD值过大,无法进行相似性比较;A、B、S溶出度均符合《中国药典》限度规定,RSD值B>S>A。结论: A与S体外溶出行为相似,具有可替换性;B与S体外溶出行为差异较大,出现临床疗效差异的风险较大。通过仿制药质量和疗效一致性评价的阿奇霉素片质量明显优于未通过者。

关键词: font-size:medium, ">阿奇霉素片;溶出曲线;溶出度

Abstract: Objective: A comparative study was made on the difference of dissolution behavior between commercial azithromycin tablets which had passed or failed consistency evaluation of generic drugs quality and efficacy. Methods: The dissolution parameters were determined by referring to the dissolution curve in IF file of Azithromycin tablets of Nippon Kogyo Co., Ltd. and Kyowa Pharmaceutical Industry Co., Ltd. And the relevant guiding principles in China, the dissolution amount was determined by HPLC, the dissolution curve was drawn, the similarity of dissolution curves of azithromycin tablets from three manufacturers in different dissolution media was evaluated by f2 factor method, and whether each dissolution met the limit standard was evaluated by referring to the method in Chinese Pharmacopoeia. Results: With pH 1.2, pH 6.8, pH 4.5 and water as the dissolution medium, four dissolution curves of A, B and S were obtained. With S as the reference preparation, the f2 values of A were all greater than 50, and all the four curves were similar. The f2 values of the first two dissolution curves of B is greater than 50, and the latter two cannot be compared for similarity due to the large intra-batch RSD value. The dissolution rates of A, B, and S are in compliance with the requirements of Chinese Pharmacopoeia, and the intra-batch uniformity of B is the worst. Conclusion: The in vitro dissolution behavior of A and S is similar, which could be substitute for each other. The dissolution behavior of B and S is quite different, and there is likely to be different in clinical efficacy. The quality of azithromycin tablets passed consistency evaluation of generic drugs quality and efficacy was significantly better than those have not passed.

Key words: font-size:medium, ">Azithromycin tablets; Dissolution curve; Dissolution rate

中图分类号: