成文昭,方灿,杨芳芳,张志宇,李松
CHENG Wenzhao,FANG Can,YANG Fangfang,ZHANG Zhiyu,LI Song (Guizhou Provincial Institute for Drug Control

• 1:贵州省药品检验所

摘要(Abstract)：

目的:采用药物溶出度测定仪考察2009年国家评价性抽验计划中16个企业生产的298批次格列本脲片的溶出曲线,比较产品的内在质量差异,分析现行溶出度方法的质量可控性。方法:按照中国药典2005年版溶出度测定法测定单点溶出度,以及分别按照日本橙皮书、美国FDA药品审评部门仿制药办公室公布的溶出度试验条件、英国药典(BP)2008版中格列本脲片溶出度测定法测定溶出曲线。结果:本次2009年国家评价性抽检的16个生产企业共298批样品,按中国药典2005年版二部进行检验,均符合规定;对这16个生产企业的格列本脲片进行溶出曲线评价,1个生产企业的格列本脲片批间重复性较好,大部分样品批间的溶出曲线存在较大差异,个别企业片间溶出曲线有较大的差异,反映出产品内在质量的稳定性和均一性较差。结论:用单点溶出度控制药物学溶出行为,对很多产品而言不能全面准确地反映产品的溶出性能与内在质量,特别是不能反映出产品之间的质量差异。
Objective: To investigate the dissolution of 298 batches of glibenclamide tablets from 16 manufacturers,compare the differences of their intrinsic quality,and to analyze the quality controllability of current dissolution method.Methods: Single-point dissolution curves of the subjects were determined with dissolution tester on the basis of CP 2005 Edition,according to dissolution test conditions and methods published by Japanese Orange Book and BP 2008 Edition by Generic Drugs Office of Drug Evaluation Department,U.S.FDA.Results:(1) All of the specimens met the requirement of CP 2005 Edition;(2) Only products from 1 manufacturer had good reproducibility between different batches,while specimens from most manufacturers showed big differences between different batches,even between different tablets of a same batch,which reflected the stability and uniformity of product intrinsic quality were not good.Conclusion: Single-point dissolution test method can not reflect the dissolution performance and intrinsic quality of most products accurately,especially quality differences between different products.

关键词(KeyWords)： 降血糖药;糖尿病,非胰岛素依赖型;格列本脲片;溶出曲线
hypoglycemic agents;diabetes mellitus,non-insulin-dependent;glibenclamide tablets;dissolution curve

Abstract:

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基金项目(Foundation):

作者(Author): 成文昭,方灿,杨芳芳,张志宇,李松
CHENG Wenzhao,FANG Can,YANG Fangfang,ZHANG Zhiyu,LI Song (Guizhou Provincial Institute for Drug Control

DOI: 10.19367/j.cnki.1000-2707.2010.04.014

参考文献(References)：

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• [2]国家药典委员会.中国药典[S].北京:化学工业出版社,2005:595.
• [3]British Pharmacopoeia Commission office.The stationeryoffice on behalf of the Medicines and Healthcare products[S].Regulatony Ageneg,2008:2625.

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