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• 评价技术与方法 • 上一篇    下一篇

盐酸西替利嗪片仿制药与原研药的溶出度一致性评价

贾文君,仝立卿   

  1. 南京市食品药品监督检验院,南京市食品药品监督检验院
  • 收稿日期:2017-09-04 修回日期:2017-09-04 出版日期:2017-12-25 发布日期:2017-12-25

Consistency Evaluation of Dissolubility of Generic and Original Preparation of Cetirizine Hydrochloride Tablet

Jia Wenjun and   

  1. Nanjing Institute for Food and Drug Control,Nanjing Institute for Food and Drug Control
  • Received:2017-09-04 Revised:2017-09-04 Online:2017-12-25 Published:2017-12-25

摘要: 目的:比较不同厂家盐酸西替利嗪片溶出曲线的相似性,为该品种仿制药质量一致性评价工作提供参考。方法:参考《中华人民共和国药典》2015年版盐酸西替利嗪片溶出方法,考察了国内3个厂家盐酸西替利嗪片与进口制剂分别在纯水、pH 1.0盐酸溶液、pH 4.5醋酸-醋酸钠缓冲液与pH 6.8磷酸盐缓冲液中的溶出行为,并采用f2相似因子法评价其相似性。结果:在4种溶出介质中,B厂与参比制剂溶出曲线相似,A厂和C厂产品与参比制剂溶出曲线具有显著差异。结论:不同厂家生产的盐酸西替利嗪片,其溶出行为存在较大差异,建议与原研药溶出曲线不一致的厂家改进制剂的处方工艺以提高药品质量。

Abstract: Objective: To compare the dissolution profiles of cetirizine hydrochloride tablets from different manufacturers to provide information for generic drugs quality consistency evaluation. Methods: According to the dissolution test method mentioned in the Chinese Pharmacopeia 2015 edition, the dissolution behavior of three domestic cetirizine hydrochloride tablets and imported drug was investigated in water, pH 1.0 hydrochloric acid solution, pH 4.5 acetate buffer solution and pH 6.8 phosphate buffer solution. The similarity of dissolution profiles was analyzed by the f2 factor method. Results: The dissolution profiles of cetirizine hydrochloride tablets from manufacturer B were all similar to the reference preparation in four dissolution medium, but the dissolution profiles of cetirizine hydrochloride tablets from manufacturer A and manufacturer C were significantly different from that of the reference preparation. Conclusion: There was a significant difference in dissolution behavior of cetirizine hydrochloride tablets from different manufacturers. It is advised that manufacturers should improve the product quality by changing the formulation and preparation process.