注射用七叶皂苷钠细菌内毒素检查方法研究(1)
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摘 要:目的:建立注射用七叶皂苷钠细菌内毒素检查法。方法:采用《中华人民共和国药典》2005年版附录细菌内毒素检查法。结果:注射用七叶皂苷钠浓度为0.05mg•mL-1,用灵敏度为0.25EU•mL-1的鲎试剂检测细菌内毒素无干扰因素的影响。结论:注射用七叶皂苷钠可应用鲎试剂进行细菌内毒素检查。
关键词:注射用七叶皂苷钠;细菌内毒素;干扰试验
中图分类号:R282.5文献标识码:A
文章编号:1673-7717(2008)05-0920-02
Study on Bacterial Endotoxin Test to Sodium Aescinate for Injection
JI Yang,WANG Wenjun,SHEN Juan,HU Dan,NIE Yuqiong,GAO Jin
(Institute for Drug and Instrument Control of Health Department GLD of PLA,Beijing 100071,China)
Abstract:Objective:To Establish detection method of bacterial endotoxin test to sodium aescinate for injection. Methods: According to thebacterial endotoxin test inChinese pharmacopoeia 2005 edition.Results: It was proved that the maximum noninterference concentration was 0 ......
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