升压物质检查法在药品生物安全性检查中的应用及实验关键点
Application of Vasopressor Activity Test in Drug Biological Safety Tests and Analysis of Experimental Key Points
张媛 1郭龙静 1吴彦霖 1杨泽岸 1纳涛1
作者信息
- 1. 中国食品药品检定研究院,北京 102629
- 折叠
摘要
升压物质检查法是《中国药典》收录的一项药物安全性检查法.用以检测可能含有引起血压升高杂质的原料药及其制剂中升压物质的限度是否符合标准规定.该检查法的使用范围虽然较窄,但在临床用药安全上发挥着重要作用.本文就升压物质检查法的实验原理、实验系统、方法应用、各国药典收录情况、改进建议,以及实验要点进行综述,为相关实验人员提供参考.
Abstract
The vasopressor activity test is one of the drug biological safety test method included in the Chinese Pharmacopoeia.It is used to detect whether the limits of vasopressor in APIs and related preparations that may contain impurities which may raise blood pressure meet the standard requirements.Although the application of this test is narrow,it plays an important role in the safety of clinical treatment.This article summarizes the experimental principles,experimental systems,method applications,improvement suggestions,and experimental key points of the vasopressor activity test,so that provides references for relevant experimenters.
关键词
升压物质检查法/升压素/血压/生物安全性检查Key words
vasopressor activity test/vasopressin/blood pressure/biological safety tests引用本文复制引用
出版年
2024
NETL
NSTL
万方数据