平行人工膜渗透性测定法初步预测格列吡嗪片的生物等效性  

Preliminary Prediction of Bioequivalence of Glipizide Tablets Based on Parallel Artificial Membrane Permeability Assay

作　　者：王松 于明艳 张丹丹 刘文坤 陈德俊 WANG Song;YU Mingyan;ZHANG Dandan;LIU Wenkun;CHEN Dejun(Shandong Research Center of Engineering and Technology for Consistency Evaluation of Generic Drugs,NMPA Key Lab.for Research and Evaluation of Generic Drugs,Shandong Institute for Food and Drug Control,Jinan 250101)

机构地区：[1]山东省食品药品检验研究院国家药品监督管理局仿制药研究与评价重点实验室,山东省仿制药一致性评价工程技术研究中心,山东济南250101

出　　处：《中国医药工业杂志》2024年第9期1244-1249,共6页Chinese Journal of Pharmaceuticals

摘　　要：采用平行人工膜渗透性测定(PAMPA)法对药物的体外溶出与渗透速率进行研究,初步预测格列吡嗪片仿制制剂的生物等效性。使用Macro Flux型药物生物等效性预测系统,考察3个厂家受试制剂与参比制剂在空腹和饱腹条件下的溶出与渗透过程,通过比较渗透速率和总渗透量2个关键质量参数,预测受试制剂是否与参比制剂生物等效。已通过一致性评价的1批受试制剂关键质量参数的几何均值比的90%置信区间在80.00%~125.00%,另外2批受试制剂未在此区间,但其中1批受试制剂与参比制剂的溶出曲线相似。所建立的PAMPA可为制剂的处方筛选与生物等效性风险评价提供技术支持。To preliminarily predict the bioequivalence of glipizide tablets,the in vitro dissolution and permeation rates were studied with the parallel artificial membrane permeability assay(PAMPA).The Macro Flux system for drug bioequivalence prediction was used to investigate the dissolution and permeability processes of three test preparations and the reference preparation in the fasting and fed states.To predict whether the test preparations were bioequivalent to the reference preparation,two key quality parameters,namely the permeation rate and the total permeation amount,were compared.The 90%confidence interval of the geometric mean ratio of the quality parameters that passed the consistency evaluation was in the range of 80.00%-125.00%.For the others that did not fall into this interval,one batch of the test preparation had a similar dissolution curve to the reference preparation.The PAMPA may provide support for the prescription screening and bioequivalence risk assessment of preparations.

关 键 词：格列吡嗪片 平行人工膜渗透性测定 体外溶出 渗透速率 生物等效性 

分 类 号：R917[医药卫生—药物分析学] R977.15[医药卫生—药学]