不同厂家泮托拉唑钠肠溶制剂的溶出一致性研究  

The consistency evaluation of the dissolution of pantoprazole sodium enteric preparation from different manufacturers

作　　者：李浩然[1] 康宇 董劼[1] 赵晓晓 张志清[1] LI Haoran;KANG Yu;DONG Jie;ZHAO Xiaoxiao;ZHANG Zhiqing(Department of Pharmacy,the Second Hospital of Hebei Medical University,Shijiazhuang 050000,China)

机构地区：[1]河北医科大学第二医院药学部,石家庄050000

出　　处：《西北药学杂志》2020年第6期885-888,共4页Northwest Pharmaceutical Journal

基　　金：河北省重点研发计划项目(编号:192777127D)。

摘　　要：目的考察不同厂家泮托拉唑钠肠溶制剂体外溶出行为的一致性。方法以原研药为参比制剂,采用篮法进行溶出实验,考察不同厂家泮托拉唑钠肠溶制剂在0.1 mol·L^(-1)盐酸、pH 6.0和6.8的磷酸盐缓冲液(PBS)3种介质中的溶出行为,采用HPLC法测定泮托拉唑钠的含量并计算其释药量,以相似因子法比较溶出行为的相似性。结果泮托拉唑钠肠溶制剂在0.1 mol·L^(-1)盐酸中的溶出行为与原研药相似,在pH 6.0 PBS中有6个仿制药与原研药溶出行为相似,而在pH 6.8 PBS中仿制药的溶出行为与原研药均不相似。结论泮托拉唑钠肠溶制剂仿制药与原研药体外溶出行为不一致。Objective To investigate the consistency of in vitro dissolution behaviors of pantoprazole sodium enteric preparations from different manufacturers.Methods The original research drug was used as the reference preparation,and the dissolution test was carried out by using basket method.The dissolution behavior of pantoprazole sodium enteric preparation from different manufacturers were investigated in 0.1 mol·L-1 hydrochloric acid,pH 6.0 and 6.8 phosphate buffer solutions(PBS).The content of pantoprazole sodium was determined by HPLC,and the drug release amount was calculated.The similarity of the dissolution behaviors was compared by the similar factor method.Results The dissolution behaviors of pantoprazole sodium enteric preparation in 0.1 mol·L-1 hydrochloric acid is similar to that of original drug.There are 6 generic drugs in pH 6.0 PBS which showed similar dissolution behaviors to original drug,while these dissolution behaviors of generic drugs in pH 6.8 PBS were different with that of original drug.Conclusion The in vitro dissolution behavior of pantoprazole sodium enteric preparations is inconsistent with that of original drug.

关 键 词：泮托拉唑钠 肠溶制剂 一致性 溶出行为 相似因子 

分 类 号：R94[医药卫生—药剂学]