一种崩解加溶出考察固体制剂质量的序贯检测方法  

A Sequential Analysis Method of Drug Disintegration and Dissolution Test for Quality Investigation of Solid Preparations

作　　者：耿东升[1] 王晓娟[1] 赵婷[1] 

机构地区：[1]新疆军区联勤部药品仪器检验所,乌鲁木齐830063

出　　处：《中国药品标准》2016年第3期184-189,共6页Drug Standards of China

基　　金：新疆维吾尔自治区自然科学基金课题--药物溶出/释放度及崩解时限测定的规范性研究(2013211A119)

摘　　要：目的:建立固体制剂的崩解和药物溶出度质量考察的序贯试验方法。方法:选取9种具有代表性的固体制剂,按照序贯试验方法,分别在三种不同酸度的崩解液中测定药品的崩解时限。统一在p H 7.6的磷酸盐缓冲液中,固定实验装置和转速,采用光纤实时药物溶出度仪监测药物溶出度,并用《中国药典》各品种项下溶出度检查规定的溶出介质作对照;药物溶出曲线采用weibull模型拟合,通过其拟合参数的变异度,评估制剂间药物溶出行为的差异程度。结果:比较各制剂在三种崩解液中的崩解时限,有的一致性好,有的差异较大;与参比制剂比较,药品崩解时限差异明显的受试制剂,其用新方法监测的药物溶出度差异也较大。结论:药品崩解加药物溶出的序贯检测方法,可以提高固体制剂质量的检验效能。Objective：To establish a sequential analysis method for quality investigation of solid preparation .Methods：9 representative solid preparations were selected , according to the sequential analysis method： firstly, disintegration times were respectively tested in 3 disintegration liquids of different acidity , and successively , dissolution of the durgs were monitored in pH 7.6 phosphate buffer , with an optical fiber in site dissolution testing instrument at a fixed speed .Simultaneously,the drug dissolution results of new method were com-pared with that of ChP demanded media .Drug dissolution curves were fitted by model weibull , the differences of the preparations were e-valuated by the variation of the fitting parameters .Results：Some preparations had good consistency and some had significant difference by comparing the disintegration time of the preparations in 3 disintegration liquids .And compared with the reference preparation , the difference of drug disintegration time was obviously great , the difference of the dissolution was also great by new method .Conclusion：The sequential analysis method of drug disintegration and dissolution test can promote efficacy of quality test of solid preparation .

关 键 词：固体制剂 序贯试验 药品崩解时限 药物溶出度 

分 类 号：R921.2[医药卫生—药学]