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

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。

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.