吲达帕胺片仿制药与原研药的溶出度一致性评价  

Consistency Evaluation of Dissolubility of Indapamide Tablets between Generic and Original Preparation

作　　者：张翔[1] 宋金春[1] 陈莉[2] ZHANG Xiang;SONG Jin-chun;CHEN Li(Renmin Hospital of Wuhan University, Hubei Wuhan 430060, China;School of Pharmacy, Wuhan University, Hubei Wuhan 430072, China)

机构地区：[1]武汉大学人民医院,湖北武汉430060 [2]武汉大学药学院,湖北武汉430072

出　　处：《中国药物警戒》2016年第7期403-407,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的比较国内3种不同吲达帕胺片仿制药与原研药的体外溶出度,并将溶出曲线进行比较评价一致性。方法采用高效液相色谱法。色谱柱为Agilent TC-C18,流动相为甲醇-水-冰醋酸(55:45:0.1),流速1 m L·min-1,检测波长为240 nm,柱温为30℃,进样量为20μL。采用桨法,溶出介质体积为900 m L,转速为50 rpm,分别以水、p H 1.2盐酸溶液、p H 4.0醋酸盐缓冲液、p H 6.8磷酸盐缓冲液为溶出介质测定溶出度,并通过计算相似因子(f2)评价二者溶出曲线的相似性。结果仅仿制药C与参比制剂D的溶出曲线基本相似,A和B与参比制剂溶出一致性差。结论部分国内仿制药与国外参比制剂溶出一致性较差,制备工艺有待改善。Objective To compare the dissolubility of three different domestic indapamide tablets with the original preparationin vitro, so as to evaluate the consistency. Methods HPLC method was adopted. The column was Agilent TC-C18, mobile phasewas methanol-water-glacial acetic acid (55:45:0.1, V/V) with a flow rate of 1 mL·min-1, the detection wavelength was 240 nm, thecolumn temperature was 30℃ , the injection volume was 20 μL. The stirring paddle method was adopted, volume of dissolutionmedium was 900 mL and roating rate was 50 rpm. The dissolution mediums were water, hydrochloric acid solution (pH1.2),acetic acid-sodium acetate buffer solution (pH4.0) and phosphate buffer solution (pH6.8). The similarity of dissolution profilewas evaluated by calculating similar factor (f2). Results Only the generic drug C has similar dissolution profile from referencepreparation D, the consistency of dissolubility of A and B was considerablely different. Conclusion The dissolution profiles ofsome domestic indapamide tablets are not consistent with its original product in vitro, the production process needs to be furtherimproved.

关 键 词：吲达帕胺 仿制药 原研药 溶出曲线 

分 类 号：R943[医药卫生—药剂学]