注射用葛根素的细菌内毒素检查法可行性研究(1)
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[摘要] 目的:对注射用葛根素进行凝胶法干扰试验,建立注射用葛根素的细菌内毒素检查试验方法。方法:采用《中国药典》2005年版二部附录收载的细菌内毒素检查法。结果:注射用葛根素稀释至浓度1.5 mg/ml时对细菌内毒素检查法无干扰作用。结论:使用细菌内毒素检查法检查注射用葛根素中的细菌内毒素是可行的,可用细菌内毒素检查法代替家兔热原检查法。
[关键词] 注射用葛根素;细菌内毒素;凝胶法;干扰试验
[中图分类号] R927[文献标识码]A [文章编号]1673-7210(2010)02(b)-057-03
Study on the method of bacterial endotoxin test of Puerarin for Injection
LI Wei,WU Ting
(Department of Pharmacology, Institute for Drug Control in Guangzhou, Guangzhou 510160, China)
[Abstract] Objective: To establish a method for bacterial endotoxin test of Puerarin for Injection. Methods: According to the method of bacterial endotoxin test approved by Chinese Pharmacopoeia 2005 edition. Results: The interference on bacterial endotoxin test can be excluded when Puerarin for Injection was diluted below 1 ......
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