品牌与标准化Issue(3)：242-244,3.DOI:10.3969/j.issn.1674-4977.2024.03.075
溶出度测定仪检定方法探讨及其测量不确定度评定
Discussion on the Calibration Method of Dissolution Tester and Its Measurement Uncertainty Evaluation
温晓东 1李艾橘1
作者信息
- 1. 广东省计量科学研究院东莞计量院,广东东莞 523343
- 折叠
摘要
Abstract
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.关键词
溶出度/检定/不确定度Key words
dissolution/calibration/uncertainty引用本文复制引用
温晓东,李艾橘..溶出度测定仪检定方法探讨及其测量不确定度评定[J].品牌与标准化,2024,(3):242-244,3.
