注射用复合辅酶降压物质检查法研究
Investigation on the depressor substance tests method of coenzyme complex for injection
张菊 1吕晓君 1周大庆 1沈佳特 1何开勇1
作者信息
- 1. 湖北省药品监督检验研究院,湖北省药品质量检测与控制工程技术研究中心,国家药品监督管理局血液制品质量控制重点实验室,武汉 430064
- 折叠
摘要
目的:观察注射用复合辅酶静脉给药对猫的急性降压作用,建立其降压物质检查法.方法:采用猫血压法比较10批注射用复合辅酶与组胺对照品引起的血压下降程度,确定其降压物质检查法的限值,按照该限值对22批样品进行降压物质检查.结果:注射用复合辅酶降压物质检查的限值拟定为3 IU·kg-1(按辅酶A计),22批注射用复合辅酶中有2批不符合规定.结论:注射用复合辅酶按拟定限值检查,方法可行,建议注射用复合辅酶质量标准中增加降压物质检查.
Abstract
Objective:To observe the acute hypotensive effect of compound coenzyme for injection on cats,and to establish a method for examination of depressor substance.Methods:Ten batches of compound coenzyme for injec-tion and histamine depressor substance were compared by cat blood pressure method to determine the limit value of depressor substance test method.According to the limit value,22 batches of samples were tested for depressor sub-stance.Results:The limit of compound coenzyme for injection was 3 IU·kg-1(calculated by coenzyme A).Two batches of 22 batches of compound coenzyme for injection did not meet the requirements.Conclusion:The method of compound coenzyme for injection is feasible according to the proposed limit value.It is suggested that the quality standard of compound coenzyme for injection should be added with the examination of depressor substance.
关键词
注射用复合辅酶/猫血压法/组胺/限值/降压物质/质量标准Key words
compound coenzyme for injection/feline blood pressure method/histamine/limits/depressor sub-stance/quality standard引用本文复制引用
基金项目
2019年国家药品抽检(国药监药管[2019]1号)
出版年
2024
NETL
NSTL
万方数据