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

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.