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目的比较原研与仿制硝苯地平口服制剂的释放度,评价其体外溶出度的一致性。方法以0.25%十二烷基硫酸钠水溶液(900 mL)为溶出介质,采用反相高效液相色谱法测定硝苯地平浓度,转篮法考察硝苯地平口服制剂释放度。结果不同厂家硝苯地平口服制剂释放速度和释放量存在差异,原研缓释片4 h释放度为标示量的59.68%,11 h释放度为标示量的82.94%;但仿制缓释片4 h释放度达标示量的109.18%;两种缓释制剂释放相似度(f2)为60.26。仿制普通片1 h累计溶出度为82.19%,2 h为88.4%。结论硝苯地平原研、仿制缓释片及仿制普通片释放度符合药典规定,但两种缓释片缓释特点存在明显差异,释放相似度较低。进行仿制药与原研药体内外一致性评价,有利于提高仿制药质量。
OBJECTIVE To compare the release of oral and oral preparations of original and simulated nifedipine to evaluate the consistency of in vitro dissolution. Methods The concentration of nifedipine was determined by RP-HPLC with 0.25% sodium dodecyl sulfate aqueous solution (900 mL) as dissolution medium. The release of nifedipine oral preparation was investigated by basket spinning method. Results The release rate and release of nifedipine in different manufacturers were different. The release rate of nifedipine was 59.68% of the labeled amount and 82.94% of the labeled amount in 4 h, Degree reached 109.18% of the labeled amount; two kinds of sustained-release preparations release similarity (f2) of 60.26. The average dissolution rate of generic tablets in 1 h was 82.19% and 88.4% in 2 h. Conclusions The release of nifedipine original research, generic sustained-release tablets and generic tablets meet the requirements of the Pharmacopoeia, but the sustained-release characteristics of the two sustained-release tablets are significantly different, and the release similarity is low. Evaluation of in-vitro and in-vivo consistency between generic drugs and original research drugs will help improve the quality of generic drugs.