实验动物科学 ›› 2024, Vol. 41 ›› Issue (3): 90-94.DOI: 10.3969/j.issn.1006-6179.2024.03.016

• 综述 • 上一篇    

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

  

  1. (中国食品药品检定研究院,北京 102629)
  • 收稿日期:2023-02-13 出版日期:2024-06-28 发布日期:2024-06-01
  • 通讯作者: 纳 涛( 1976—) ,博士,副研究员,研究方向为药检药理,E-mail:natao@ vip. 163. com。
  • 作者简介:张 媛( 1980—) ,硕士,副研究员,研究方向为药品检验,E-mail:zhyuan_cn@ 126. com。

Application of Vasopressor Activity Test in Drug Biological SafetyTests and Analysis of Experimental Key Points

  1. (National Institutes for Food and Drug Control, Beijing 102629, China)
  • Received:2023-02-13 Online:2024-06-28 Published:2024-06-01

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。

关键词: 升压物质检查法, 升压素, 血压, 生物安全性检查

Abstract: The vasopressor activity test is one of the drug biological safety test method included in theChinese Pharmacopoeia. It is used to detect whether the limits of vasopressor in APIs and relatedpreparations 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 clinicaltreatment. This article summarizes the experimental principles, experimental systems, methodapplications, improvement suggestions, and experimental key points of the vasopressor activity test, sothat provides references for relevant experimenters.

Key words: vasopressor activity test, vasopressin, blood pressure, biological safety tests

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