自研硝苯地平缓释片(Ⅲ)与对照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 tablets(Ⅲ) and contrast preparation

作　　者：高永坚 袁春平[1] 黄后楷[1] 张文芳[1] 

机构地区：[1]国药集团广东环球制药有限公司,佛山528303

出　　处：《药物分析杂志》2017年第2期362-368,共7页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:评价自研硝苯地平缓释片(Ⅲ)与对照制剂体外释放行为的一致性。方法:采用高效液相色谱法,色谱柱为Zorbax SB-C_(18)柱(150 mm×4.6 mm,5μm),流动相为甲醇-乙腈-水(25∶25∶50),流速1.0 m L·min^(-1),检测波长235 nm。根据仿制药质量一致性评价要求,分别考察在桨法,100 r·min^(-1)转速条件下,自研制剂与对照制剂在pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液及水(均含0.5%十二烷基硫酸钠)中的体外释放行为;考察3批自研制剂释放曲线的均一性和重现性。结果:自研制剂与对照制剂在4种不同的释放介质中释放曲线均相似(f_2因子>50),且自研制剂0 d样品与加速6个月的样品释放曲线基本重叠;自研制剂的均一性和重现性均符合技术要求。结论:自研制剂与对照制剂体外释放度基本一致。Objective：To evaluate the consistency of the in vitro release behavior between self-prepared nifedipine extended-release tablets（Ⅲ）and contrast preparation（Adalat GITS）.Methods：The dissolution was analyzed by HPLC method.Zorbax SB-C18（150 mm×4.6 mm,5 μm）column was used with the mobile phase of a mixture of methanol,acetonitrile and water（25∶25∶50）.The flow rate was 1.0 m L·min^-1,and the detection wavelength was 235 nm.According to requirements of evaluation for the quality consistency of generic drugs,the release behavior of self-prepared preparation and contrast preparation in p H 1.2 hydrochloric acid solution,p H 4.0 acetate buffer solution,pH 6.8 phosphate buffer solution and water（the solutions above contained 0.5% sodium lauryl sulfate）was investigated under the condition of paddle method at the rotational speed of 100 r·min^-1;the homogeneity and reproducibility on the release curves of three batches of self-prepared preparation was analyzed.Results：Therelease curves of self-prepared preparation were similar to that of the contrast preparation（f_2 factors 50）;the release curves of the initial samples and the samples after six months＇ accelerated trial of self-prepared preparation overlapped to Ceach other;the homogeneity and reproducibility of self-prepared preparation met the technical requirements.onclusion：The self-prepared preparation shows consistent in vitro release behavior with that of the contrast preparation.

关 键 词：硝苯地平 缓释片 释放度 释放曲线 F2因子 一致性评价 

分 类 号：R917[医药卫生—药物分析学]