盐酸曲美他嗪片仿制药与原研药的体外溶出度一致性评价

目的：比较国内三个厂家盐酸曲美他嗪片与原研药的体外溶出度。方法：以水、pH 1.0盐酸溶液、pH 6.8磷酸盐缓冲液为溶出介质,浆法,转速为50 r·min-1,溶出介质体积为900 mL,采用紫外分光光度法,检测波长232 nm,进行溶出度测定。通过相似因子f2法评价仿制药与原研药溶出曲线的相似性。结果：其中丙厂的仿制药在3种介质中与进口药物的溶出曲线均相似,甲乙两厂的仿制药仅在水中的溶出曲线与原研药相似,但在另两种介质中较原研药溶出更快。结论：三厂家的盐酸曲美他嗪片的溶出度均符合《中国药典》规定,但较多仿制药与原研药的体外溶出行为有差异,需进一步结合生物等效性结果考察仿制药质量。

Consistency of Dissolubility of Trimetazidine Dihydrochloride Tablets Generic and Original Preparation

Objective: To compare the dissolubilities of three domestic trimetazidine dihydrochloride tablets with those of the original drugs. Methods: The dissolution of trimetazidine dihydrochloride tablets were determined in water, pH 1.0 hydrochloric acid solution and pH 6.8 phosphate buffer, respectively. The dissolution tests were proceeded by paddling at 50 r·min-1 in 900 mL dissolution medium. And the drug was determined by an ultraviolet-visible spectrophotometer at 232 nm. The differences of dissolution rates among the reference and the 3 domestic products were evaluated by a similarity factor method. Results: All prod-ucts tested conformed to the quality requirements of Chinese Pharmacopoeia. The dissolution curves of one domestic product were all similar to those of the reference tablets. While the other two home products had similar dissolution curves only in water. Conclusion: There are some differences in the dissolution behav-ior. Further bioequivalence tests need to be carried out to determine whether there is any therapeutic dis-crepancy among different trimetazidine dihydrochloride tablets.