动态浊度法测定注射用QHMT中细菌内毒素含量  

Bacterial Endoxin Test for QHMT Freeze-dried Powder Injection by Dynamic Turbidimetric Asssy

作　　者：王团结[1,2] 王艳艳[3] 刘俊超[1,2] 杨绪芳[1,2] 孙永成[1,2] 孟瑾[1,2] 李峰[1,2] 萧伟[1,2] 

机构地区：[1]江苏康缘药业股份有限公司,江苏连云港222001 [2]中药制药过程新技术国家重点实验室,江苏连云港222001 [3]江苏联合职业技术学院连云港中医药分院,江苏连云港222006

出　　处：《现代中药研究与实践》2016年第2期48-50,共3页Research and Practice on Chinese Medicines

基　　金：现代中药创新集群与数字制药技术平台-国家重大新药创制专项项目(2013ZX09402203)

摘　　要：目的通过以动态浊度法考察注射用QHMT细菌内毒素干扰的情况,建立其细菌内毒素定量分析方法。方法采用《中国药典》2010版(一部)附录ⅩⅢD细菌内毒素检查法中的动态浊度法。结果干扰试验表明:用标示灵敏度为0.03 Eu/ml的鲎试剂,将注射用QHMT稀释至1.4 mg/ml,对细菌内毒素检查无干扰。结论用细菌内毒素检查法检查注射用QHMT中细菌内毒素是可行的,该方法安全可靠,无干扰;可用细菌内毒素检查法(动态浊度法)代替家兔热原检查法控制其热原。Objective To study the interference of QHMT Freeze-dried powder injection in bacterial endotoxin test with dynamic turbidimetric assay and to establish endotoxin test method. Methods Inhibition or enhancement test for bacterial endotoxin test was used according to appendix X ⅢD of China Pharrmacopoeia I （2010 edition）. Results It was experimented that the samples showed non-interference action on bacterial endooxin test with marked sensitivity 0.03 Eu/ml linulus reagent when the samples were diluted to a concentration of 1.4 mg/ml. Conclusion The bacterial test method was suitable for QHMT Freeze-dried powder injection and this method was safe, reliable and non-interferecce; And it could be replaced rabbit pyrogen method to control the pyrogen.

关 键 词：注射用QMHT 细菌内毒素 动态浊度法 干扰试验 

分 类 号：R927.1[医药卫生—药学]