国产与原研盐酸环丙沙星片的溶出曲线比较研究.PDFVIP

中国药事 2016 年 9 月 第 30 卷 第 9 期 919 国产与原研盐酸环丙沙星片的溶出曲线比较研究 周晓溪，常俊兰，付晓丽，王丹 （山西省食品药品检验所，太原 030001） 摘要 目的：比较国产盐酸环丙沙星片与国外原研制剂在 4 种不同溶出介质中的溶出曲线 , 为仿制药质 量一致性评价提供参考。方法：采用桨法，转速 50 r·min-1 ，分别以 pH 1.2 盐酸溶液、pH 4.5 醋酸盐缓 冲液、pH 6.8 磷酸盐缓冲液 、水各 900 mL 为溶出介质，采用 HPLC 法在波长 278 nm 检测并绘制溶出曲 线，采用f 2 因子法进行比较分析。结果与结论 ：所建立的方法可用于盐酸环丙沙星片的一致性评价。检 测结果显示，仅有 1 家企业样品的溶出曲线在 4 种溶出介质中与原研制剂相似，其他企业的产品都与原 研制剂不相似。 关键词： 盐酸环丙沙星片；溶出曲线；一致性评价 中图分类号： R927.1 文献标识码：A 文章编号： 1002-7777(2016)08-0919-05 doi:10.16153/j.1002-7777.2016.09.013 A Comparative Study on Dissolution Profiles between generic Ciprofloxacin Hydrochloride Tablets and Original Tablets Zhou Xiaoxi, Chang Junlan, Fu Xiaoli,Wang Dan (Shanxi Institute for Food and Drug Control, Taiyuan 030001, China) Abstract Objective: To determine the dissolution profiles of generic ciprofloxacin hydrochloride tablets and the original product in four dissolution mediums, so as to aid the re-evaluation of generics equivalency of the product. Methods: The dissolution process of ciprofloxacin hydrochloride tablets was determined by paddle method. The pH 1.2 hydrochloric acid solution, the pH 4.5 acetate buffer solution, the pH 6.8 phosphate buffer solution and water were used as dissolution mediums. The rotation rate of paddle was 50 r min-1. The concentrations of · samples in different mediums were determined by HPLC with UV detector (278 nm) and comparatively analyzed by f 2 factor method. Results and Conclusion: In Vitro dissolution profiles can be used for equivalency re- evaluation of generic ciprofloxacin hydrochloride tablets. The results showed that only one manufacturer’s product was similar to the original product in all four dissolution mediums and the others all exhibited obvious differences. Keywords: ciprofloxacin hydrochloride tablets; dissolution profiles; in vitro generic eq