注射用阿奇霉素磷酸二氢钠细菌内毒素检测方法的研究  

Studies on Determination of Bacterial Endotoxin of Azithromycin Sodium Dihydrogen Phosphate for Injection

作　　者：翟霞[1] 陈佳[2] 

机构地区：[1]江苏省扬子江药业集团股份有限公司,泰州225300 [2]江苏省泰州市食品药品检验所,泰州225300

出　　处：《海峡药学》2015年第6期50-53,共4页Strait Pharmaceutical Journal

摘　　要：目的对注射用阿奇霉素磷酸二氢钠进行凝胶法干扰试验,建立注射用阿奇霉素磷酸二氢钠细菌内毒素检查的试验方法。方法采用中国药典2010年版二部附录收载的细菌内毒素检查方法。结果浓度为0.10mg·m L-1的样品稀释液对标示灵敏度为0.125EU·m L-1的鲎试剂无干扰作用。结论使用细菌内毒素检查法检查注射用阿奇霉素磷酸二氢钠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。OBJECTIVE To establish a method for the determination of bacterial endotoxin of azithromycin sodium dihydrogen phosphate for injection; METHODS The method of determination of bacterial endotoxin approved by Chinese Pharmacopoeia 2010 edition were adopted. RESULTS No interferential effect was under the density0. 1mg·m L^- 1of the dilute test solution. The limulus amebocyte lysate reagent with the sensitivity of 0. 125 EU ·m L^- 1could be used in the test; CONCLUSION It is feasible to detect the bacterial endotoxin of azithromycin sodium dihydrogen phosphate for injection by the method of determination of bacterial endotoxin and the method may replace pyrogen test.

关 键 词：注射用阿奇霉素磷酸二氢钠 细菌内毒素试验 鲎试剂 干扰试验 

分 类 号：R282.71[医药卫生—中药学]