自研硝苯地平缓释片(Ⅰ)与原研制剂体外释放度一致性评价  

Evaluation on the in vitro release consistency between self-prepared nifedipine extended-release tablet (Ⅰ) and original preparation

作　　者：袁春平[1] 黄后楷[1] 张文芳[1] 袁丰瑞[1] 区淑蕴[1] 

机构地区：[1]广东环球制药有限公司,佛山528305

出　　处：《药物分析杂志》2013年第8期1416-1423,共8页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:评价自研硝苯地平缓释片(Ⅰ)与原研制剂(Adalat-L10)体外释放行为的一致性。方法:参照日本原研制剂(Adalat-L10)的释放度试验条件,分别考察自研制剂与原研制剂0 d样品、加速6个月样品在pH 1.2人工胃液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液及水中的体外释放行为;考察自研制剂与原研制剂在不同转速下释放曲线的相似性;考察3批自研制剂释放曲线的均一性和重现性。结果:自研制剂与原研制剂0 d样品、加速6个月的样品在4种不同的释放介质中释放曲线均相似(f2因子>50),且0 d样品与加速6个月的样品释放曲线基本重叠;自研制剂与原研制剂在不同转速下释放曲线相似;自研制剂的均一性和重现性均符合技术要求。结论:自研制剂与原研制剂体外释放度一致,且可产业化。Objective： To evaluate the consistency of the in vitro release behavior between self-prepared nifedipine extended-release tablet（Ⅰ） and original preparation（Adalat-L10）.Methods： According to the dissolution test conditions of the original preparation（Adalat-L10） from Japan,the release behavior of the initial samples,samples after six months＇ accelerated trial of self-prepared preparation and original preparation in pH 1.2 solution,pH 4.0 acetate buffer,pH 6.8 phosphate buffer and water were inspected;the release curves of self-prepared preparation and original preparation under different speeds of revolution were investigated;the homogeneity and reproducibility on the release curve of three batches of self-prepared preparation was also analyzed.Results： The release curves of the initial samples and the samples after six months＇ accelerated trial of self-prepared preparation were similar to that of the original preparation（f2 factors 50）;the release curves of the initial samples and the samples after six months＇ accelerated trial of self-prepared preparation overlapped to each other;the release curves of self-prepared preparation under different speeds of revolution were similar to that of the original preparation;the homogeneity and reproducibility of self-prepared preparation met the technical requirements.Conclusion： The self-prepared preparation shows consistent in vitro release behavior with that of the original preparation and can be industrially prepared.

关 键 词：硝苯地平 缓释片 释放度 F2因子 一致性评价 

分 类 号：R544.1[医药卫生—心血管疾病]