多潘立酮片体外溶出的一致性评价  

The quality consistency evaluation of domperidone tablets in vitro

作　　者：王海莹 杨星钢[2] 魏斌斌[1] 潘卫三[2] WANG Haiying;YANG Xinggang;WEI Binbin;PAN Weisan(School of Pharmacy,China Medical University,Shenyang 110122,China;School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016)

机构地区：[1]中国医科大学药学院,辽宁沈阳110122 [2]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2021年第3期238-242,共5页Journal of Shenyang Pharmaceutical University

摘　　要：目的考察原研地产化参比制剂的质量,比较参比制剂与国产仿制制剂的溶出一致性并制备与参比制剂溶出相似的自制制剂。方法建立了多潘立酮UV的体外溶出测定方法,以pH 1.2、pH 6.0、pH 6.8和水为溶出介质考察三个批次的参比制剂、三种国内市售仿制制剂以及自制制剂的溶出行为,采用溶出相似因子(f_(2))法评价溶出行为的相似性。结果原研地产化的三批参比制剂之间f_(2)均大于50,三种国内市售制剂的溶出与参比制剂相比f_(2)存在小于50的情况,自制制剂与参比制剂相比f_(2)均大于50。结论原研地产化多潘立酮片质量良好,符合参比制剂的要求;市售仿制的三个品种多潘立酮片与参比制剂溶出差异较大,制剂的处方、工艺有待优化;自制制剂与参比制剂的体外溶出相似,溶出一致性良好;同时参比制剂、国产市售制剂和自制制剂的含量和有关物质均符合规定标准。Objective To investigate the quality of the references, compare the dissolution curves of reference domperidone tablets and generic drugs and prepare the self-made formulation which is similar to the references.Methods The precise and simple UV method was chosen to test the dissolution of domperidone tablets in vitro,the dissolution mediums were set at pH 1.2,pH 6.0,pH 6.8 and purified water.The similarity of dissolution curves was determined by f_(2) similarity factor method.Results The dissolution curves showed that the three batches were very similar(f_(2) was greater than 50)and the f_(2) of generic drugs dissolution in four media was less than 50 comparing with reference tablets.At the same time, the f_(2) of self-made tablets was greater than 50.Conclusions The quality of domperidone meets the requirement of references.There exists significant difference between reference and generic drugs, the quality of formulation and process need to be improved.In this study, the dissolution of self-made tablets is similar to that of reference and the quality consistency is good.The contents and impurities of reference, domestic generic and self-made comply with the quality standard.

关 键 词：多潘立酮片 参比制剂 市售制剂 自制制剂 溶出曲线 相似因子f_(2) 一致性评价 

分 类 号：R94[医药卫生—药剂学] R917[医药卫生—药学]