动态浊度法定量测定黄芪注射液中细菌内毒素的含量 - 中国现代应用药学.pdf

动态浊度法定量测定黄芪注射液中细菌内毒素的含量 卢文斌(泉州市药品检验所，福建 泉州 362000) 摘要：目的 应用动态浊度法鲎试验定量测定黄芪注射液中的细菌内毒素含量。方法 通过干扰试验确定样品检测浓度， 并建立标准曲线对不同的样品进行细菌内毒素的定量测定。结果 样品用BET 水制成1 ∶5 稀释液，对鲎试验检查无干 扰，细菌内毒素回收率在50% ～200%之间。样品中的内毒素含量可定量测定，检测结果与凝胶法检测的结果有一定的相 关性。结论 动态浊度法可用于黄芪注射液中细菌内毒素定量检测。 关键词：黄芪注射液；细菌内毒素；动态浊度法 中图分类号：R927.33 文献标志码：B 文章编号：1007-7693(2012)03-0271-03 Detection of Bacterial Endotoxin in Huangqi Injection by the Method of Kinetic Turbidimetric Limulus Test LU Wenbin(Quanzhou Institute for Drug Control, Quanzhou 362000, China) ABSTRACT: OBJECTIVE To detect the quantity of endotoxin in huangqi injection by the method of kinetic turbidimetric limulus test. METHODS The kinetic turbidimetric limulus test was applied to detect the quantity of endotoxin in several samples. The standard endotoxin working curve was set up and the interference test was studied to range the effective concentrations of sample. RESULTS Dilution ratio of Huangqi injection at 1 ∶5 show no inference in the test. The endotoxin recovery rate was more than 50% and less than 200%. The endotoxin level in samples could be quantified exactly, and the results were accorded with the results obtained by gel-clot technique assay. CONCLUSION The kinetic turbidimetric limulus test can be used to quantitate the endotoxin level in huangqi injection. KEY WORDS: Huangqi injection; bacterial endotoxin; kinetic turbidimetric limulus test 黄芪注射液为黄色或淡棕黄色的澄明液体， 黄芪注射液中的细菌内毒素定量检测进行了研 功能主治为益气养元扶正祛邪，养心通脉，健 究，通过干扰试验和回收率试验，探索黄芪注射 脾利湿。用于心气虚损、血脉瘀阻之病毒性心 液细菌内毒素定量检测法，以期实现对本品科学、 肌炎、心功能不全及脾虚湿困之肝炎。黄芪注 简捷、准确的定量检测方法。 射液由黄芪、依地酸二钠、碳酸氢钠、甘油组 1 仪器与试药 成，原质量标准中相关项目的检查方法为家兔 黄芪注射液( 批号：090821-1 、101006-2 、 法热原检查，现在多用内毒素法替代家兔法。肌 110723-2，规格：10 mL，上海新亚药业高邮有限 内注射，每次