摘要
溶出度测定仪是测量药物在固体制剂中释放速率和程度的仪器,广泛应用于药品检测,其校准结果的准确性直接影响药品质量。目前仅有JB/T 20076—2013《药物溶出试验仪》和《中华人民共和国药典》对溶出度测定仪的计量性能提出要求,但并没有相应的规程或规范对其溯源方法提出明确要求。本文研究了溶出度测定仪检定方法并对不确定度进行评定,该方法已被采纳为广东省地方检定规程。
Dissolution tester is an instrument to measure the rate and extent of drug release in solid preparations,which is widely used in drug testing,and the accuracy of its calibration results directly affects the reliability of drug quality.At present,only JB/T 20076—2013 Dissolution tester and Pharmacopoeia of the People's Republic of China put forward requirements on the metrological performance of the dissolution tester,and there is no corresponding protocol or specification for its traceability method to put forward clear requirements.In this paper,the dissolution tester calibration method is studied and the uncertainty is evaluated,and the method has been adopted as the local calibration procedure of Guangdong Province.
作者
温晓东
李艾橘
WEN Xiaodong;LI Aiju(Dongguan Institute of Guangdong Institute of Metrology,Dongguan 523343,China)
关键词
溶出度
检定
不确定度
dissolution
calibration
uncertainty
