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

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-C₁₈柱（150 mm×4.6 mm，5μm），流动相为甲醇-乙腈-水（25：25：50），流速1.0 mL·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（f₂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 mL·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 pH 1.2 hydrochloric acid solution, pH 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: The release curves of self-prepared preparation were similar to that of the contrast 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 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 contrast preparation.

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