目的 建立克林霉素磷酸酯注射液组胺类物质检查法,为该品种降压物质检查提供一种补充方法。方法 根据《中国药典》2020年版四部中“注射剂安全性检查法应用指导原则”,分别确定组胺对照品低剂量、高剂量组浓度,计算克林霉素磷酸酯注射液组胺类物质检查限值及最小有效稀释浓度(MVC),在此基础上进一步对其进行方法学研究,确认供试品MVC是否会干扰组胺类物质检查。结果 克林霉素磷酸酯注射液的MVC对组胺类物质检查无干扰作用,受试物组胺类物质不超过安全限值。结论 克林霉素磷酸酯注射液组胺类物质检查法可行。
Abstract
OBJECTIVE To establish a test method for histamines in clindamycin phosphate injection and provide a supplementary method for the test of antihypertensive substances of this variety. METHODS According to the "Guiding Principles for the Application of Injection Safety Inspection Method" in the 2020 edition of Chinese Pharmacopoeia, the concentrations of the histamine reference substance low and highdose groups were determined, reasonable histamine inspection limits and minimum effective dilution concentration (MVC) for clindamycin phosphate injection were calculated, on this basis, further methodological research was carried out to confirm whether the concentration of the test product would interfere with the inspection of histamines. RESULTS The MVC of clindamycin phosphate injection did not interfere with the examination of histamines. CONCLUSION The established histamine inspection method is feasible for clindamycin phosphate injection.
关键词
克林霉素磷酸酯注射液 /
降压物质 /
组胺类物质
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Key words
clindamycin phosphate injection /
antihypertensive substance /
histamine
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中图分类号：
R917
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参考文献
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脚注
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基金
广州市市场监督管理局科技项目资助(2021kj37)
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