乙酰唑胺缓释胶囊体内外一致性评价研究

In vitro and in vivo consistency study of acetazolamide sustained-release capsules

目的考察乙酰唑胺缓释胶囊仿制制剂与参比制剂的质量一致性。方法用已验证的溶出度检测方法,对比仿制制剂与参比制剂在不同溶出介质中的溶出行为。在38名中国健康成年志愿者中进行临床生物等效性试验,评价生物等效性。结果乙酰唑胺缓释胶囊仿制制剂与参比制剂在不同溶出介质中f2均大于80。生物等效性结果显示,C_(max)、AUC_(0-t)和AUC_(0-∞)的几何均值比的90%置信区间均在80%~125%内。结论乙酰唑胺缓释胶囊仿制制剂与参比制剂等效,具有质量一致性。

Objective The acetazolamide sustained-release capsules was investigated for the consistency evaluation between the generic and reference drugs.Methods With a validated method,the similarity f2-factor of dissolution curve was evaluated between the generic and reference drugs in different dissolution medias.Clinical bioequivalence trial was conducted in 38 Chinese healthy adult volunteers to evaluate the bioequivalence of the two drugs.Results The f2-factor of the generic and reference formulations in different dissolution medias were both greater than 80.The results of the clinical bioequivalence showed that the 90% confidence intervals of the geometric mean C_(max), AUC_(0-t) and AUC_(0-∞) were within the acceptable limits(80%-125%).Conclusion The acetazolamide sustained-release capsules between the generic and reference drugs were evaluated to be consistent.