国产与原研盐酸环丙沙星片的溶出曲线比较研究  

A Comparative Study on Dissolution Profiles between generic Ciprofloxacin Hydrochloride Tablets and Original Tablets

作　　者：周晓溪 常俊兰 付晓丽 王丹 

机构地区：[1]山西省食品药品检验所,太原030001

出　　处：《中国药事》2016年第9期919-923,共5页Chinese Pharmaceutical Affairs

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p H 1.2盐酸溶液、p H 4.5醋酸盐缓冲液、p H 6.8磷酸盐缓冲液、水各900 m L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f2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。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 p H 1.2 hydrochloric acid solution, the p H 4.5 acetate buffer solution, the p H 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 f2 factor method. Results and Conclusion： In Vitro dissolution profiles can be used for equivalency reevaluation 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.

关 键 词：盐酸环丙沙星片 溶出曲线 一致性评价 

分 类 号：R927.1[医药卫生—药学]