吲达帕胺片仿制药及其参比制剂溶出曲线比对评价研究  

Evaluation of dissolution curves of indapamide tablets between generics and reference formulation

作　　者：傅孟君 姚慧慧 朱克旭 王馨远 姚尚辰[3] FU Mengjun;YAO Huihui;ZHU Kexu;WANG Xinyuan;YAO Shangchen(Hangzhou Institutes for Food and Drug Control,Hangzhou Zhejiang 310022,China;Chuzhou Food and Drug Inspection Center,Chuzhou Anhui 239000,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]杭州市食品药品检验研究院,浙江杭州310022 [2]滁州市食品药品检验中心,安徽滁州239000 [3]中国食品药品检定研究院,北京100050

出　　处：《中国药物警戒》2023年第7期763-768,共6页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2022YFC3401205)。

摘　　要：目的对不同厂家吲达帕胺片仿制药及其参比制剂的溶出曲线进行比对研究。方法采用溶出度测定法和高效液相色谱法测定13家企业吲达帕胺片仿制药及其参比制剂在不同p H溶出介质中的溶出量,并绘制溶出曲线,色谱柱为Agilent Poroshell 120 SB-C18,流动相为甲醇-水-冰醋酸(45∶55∶0.1),流速1 mL·min^(-1),检测波长为240 nm,柱温为40℃,进样量为5μL。溶出采用桨法,溶出介质体积为900 mL,转速为50 r·min^(-1),分别以水、pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液为溶出介质,并通过计算相似因子(f_(2))评价溶出曲线的相似性。结果在不同的溶出介质中,仅个别厂家仿制药与参比制剂的溶出曲线基本相似,多数厂家的仿制药与参比制剂相比均不相似。结论不同厂家生产的吲达帕胺片溶出情况有一定差异,建议有关厂家对影响制剂溶出度的辅料及生产工艺等进行改进,以期进一步提高仿制药的质量。Objective To compare the dissolution curves of indapamide tablets from different manufacturers and its reference formulation.Methods The dissolution of 13 types of generics of indapamide tablets and its reference formulation in different pH media was determined via a dissolution tester and HPLC before the dissolution curve was drawn.The column was Agilent Poroshell 120 SB-C18,the mobile phase was methanol-water-glacial acetic acid(45:55:0.1)at a flow rate of 1 mL·min^(-1),the detection wavelength was 240 nm,the column temperature was 40℃,and the injection volume was 5μL.The stirring paddle method was adopted,with the volume of the dissolution medium at 900 mL at the rotating rate of 50 r·min^(-1).The dissolution media were water,hydrochloric acid solution(pH 1.2),acetic acid-sodium acetate buffer solution(pH 4.0)and phosphate buffer solution(pH 6.8).The similarity of dissolution profiles was evaluated by calculating the similar factor(f_(2)).Results In different dissolution media,the dissolution curves of generic drugs from only a few manufacturers were similar to those of the reference formulation,but most of the dissolution curves of generic drugs from different manufacturers were not similar to those of the reference formulation.Conclusion There are differences in the dissolution of indapamide tablets produced by different manufacturers.It is recommended that relevant manufacturers improve the excipients and production processes that affect the dissolution of the preparation to improve the quality of generic drugs.

关 键 词：吲达帕胺 溶出度 溶出曲线 参比制剂 仿制药 

分 类 号：R927.1[医药卫生—药学]