摘要
目的:采用往复筒溶出度测定装置建立非洛地平缓释片的体外释放方法,比较参比制剂与仿制制剂的体外释放一致性。方法:分别以含0.3%聚山梨酯80(tween 80)、0.1%十六烷基三甲基溴化铵(hexadecyl trimethyl ammonium bromide,CTAB)、0.2%十二烷基硫酸钠(sodium dodecyl sulfate,SDS)的不同的pH缓冲液(第1排pH为1.2,第2排pH为6.5)为溶出介质,水浴温度为37℃,往复频率为10 dpm,采用往复筒装置测定参比制剂及仿制制剂的溶出曲线,并使用f2因子法评价其相似性。结果:与参比制剂相比,厂家A在3种介质均不相似,厂家B在含SDS的介质中不相似,厂家C在含聚山梨酯80和CTAB的介质中不相似。仿制制剂与参比制剂在体外溶出方面存在不同程度的差异。结论:本文建立的往复筒法模拟了胃肠道环境,其低水平的往复频率达到与桨法高转速相同的效果,在仿制药工艺改进方面具有一定参考价值。
Objective: To compare the consistency between the generic and reference formulation, a reciprocating cylinder dissolution method of in vitro release for felodipine sustained-release tablets was established. Methods: The research was determined by reciprocating cylinder apparatus with bath temperature at 37 ℃ and dip rate of 10 dpm. The dissolution profiles were studied in buffers in different pH values(1 st row: pH 1.2, 2 nd row: pH 6.5), which respectively contained 0.3% tween 80, 0.1% hexadecyl trimethyl ammonium bromide(CTAB), and 0.2% sodium dodecyl sulfate(SDS). The similarity of generic and reference formulation was evaluated by f2 factor method. Results: Compared with reference formulation, the results indicated that: The dissolutions of product of company A were not similar in three media. The dissolutions of product of company B were not similar in the medium containing SDS. The dissolutions of product of company C were not similar in two media containing tween 80 and CTAB. Conclusions: The reciprocating cylinder method with low-level dip rate was established in this study with the advantages of simulating the gastrointestinal environment and achieving the same effect as the high-level speed of the paddle method. It provides reference for the process improvement of generic drugs.
作者
袁娜娜
程杰
谢子立
宁保明
YUAN Na-na;CHENG Jie;XIE Zi-li;NING Bao-ming(Schoo of Pharmacy,Anhui University of Chinese Medicine,Hefei 230012,China;Anhui Instiute for Food and Drug Control,Hefei 230051,China;National Instilutes For Food and Drug Conurol,Beijing 102629,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2020年第7期804-809,共6页
Chinese Journal of New Drugs
基金
国家药典委员会药品医疗器械审评审批制度改革资助项目(ZG2018-4-02)。
关键词
非洛地平缓释片
溶出曲线
往复筒法
桨法
体外释放度
felodipine sustained-release tablets
dissolution profiles
reciprocating cylinder method
paddle method
in vitro dissolution
