摘要
阐述药品稳定性实验的研究进展。采用插入法和矩阵法设计稳定性实验可减少实验样本数,通过建立方程可预测稳定性实验中药品的含水量。稳定性实验不仅可以为获得批准文号后的各种变更提供依据,同时可减少相关变更的时间和成本。
This paper reviews methodologies of stability testing of drug products. The stability testing can be conducted using bracketing design or matrixing design, which reduces the needy quantity of tested samples and predicts the moisture level of tested samples by aids of pre-established equations. The stability testing offers a justification for variables of the post-marketing pharmaceuticals as well as a numerical description of the variable ,time and cost.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2006年第20期1710-1715,共6页
Chinese Journal of New Drugs
关键词
稳定性实验
含水量
插入法
矩阵法
stability testing
moisture content
bracketing
matrixing
