符合GMP标准溶出试验仪的校验研究  

Calibration study of dissolution tester in accordance with GMP standard

作　　者：于泳[1] 姚丹丹[1] 

机构地区：[1]东南大学成贤学院,江苏南京210088

出　　处：《机电信息》2016年第11期22-26,共5页

摘　　要：以RC806D溶出试验仪为例,对其校准方法进行分析。药物溶出试验仪是检测药物溶出度的一种体外试验装置,而溶出仪的校准则是保障药品质量的一个重要的措施。校准溶出仪的方法有两种:机械方法和化学方法。化学方法国内是用水杨酸标准片来校准,通过桨法、篮法、小杯法这三种装置,得出国内溶出仪校准所用方法存在的问题以及解决方法。Take the RC806D dissolution tester for instance,this article is based on the calibration method of analysis.Drug dissolution tester is an in vitro test apparatus for detecting the drug dissolution.However,calibration of dissolution is an indispensable measure to guarantee the quality of medicines.There are two dissolution tester calibration method： mechanical and chemical methods.Chemical methods：the country is used to calibrate the instrument by salicylic acid tablets.There are three calibrating equipment：oar method,basket method and small glass method.We can be aware of the problems of internal dissolution tester calibration method and find ways to solve problems.

关 键 词：溶出试验仪 溶出度 校准方法 机械方法 化学方法 

分 类 号：TQ460.72[医药卫生—药物分析学]