阿昔洛韦葡萄糖注射液细菌内毒素检查方法研究
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[摘要] 目的:建立阿昔洛韦葡萄糖注射液细菌内毒素检查方法。方法:参照《中国药典》2005年版(二部)附录Ⅺ E细菌内毒素检查方法,用不同厂家的鲎试剂对不同批号的样品分别进行干扰试验。结果:阿昔洛韦葡萄糖注射液配制至0.5 mg/ml浓度时进行细菌内毒素检查无干扰作用。结论:采用细菌内毒素检查法是可行的。
[关键词] 阿昔洛韦葡萄糖注射液;细菌内毒素;干扰试验
[中图分类号] R927.2[文献标识码]A [文章编号]1673-7210(2010)02(a)-036-02
Study on bacterial endotoxin in Aciclovir and Glucose Injection
DONG Linqing, QIU Xiangdong, HUANG Dengfeng, XU Guangzhen
(Biological Engineering, Shandong Shengli Co., Ltd., Ji'nan 250101, China)
[Abstract] Objective: To establish a method for testing bacterial endotoxin of Aciclovir and Glucose Injection. Methods: According to the bacterial endotoxin test approved by the appendix Ⅺ E of Chinese Pharmacopoeia 2005 edition volⅡ. Tachypleus Amebocyte lysate(TAL) made by different factories was used in the Aciclovir and Glucose Injection or enhancement tests. Results: Aciclovir and Glucose Injection did not interfere with bacterial endotoxin test when it was diluted to the concentration of 0 ......
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