依托泊苷脂质微球注射液热原及细菌内毒素检查方法  

Methods for testing pyrogen and bacterial endotoxin in etoposide-loaded lipid microsphere injection

作　　者：孙丹 SUN Dan(Department of Pharmacology,Liaoning Inspection and Certification Center,Liaoning Institute for Drug Inspection and Testing,Liaoning,Shenyang 110036,China)

机构地区：[1]辽宁省检验检测认证中心辽宁省药品检验检测院药理室,辽宁沈阳110036

出　　处：《中国医药科学》2022年第3期71-74,90,共5页China Medicine And Pharmacy

摘　　要：目的对依托泊苷脂质微球注射液进行热原和细菌内毒素检查实验,制订其热原及细菌内毒素控制标准,保证产品质量及用药安全。方法按《中华人民共和国药典》2015年版四部“9301注射剂安全性检查法应用指导原则”“1142热原检查法”和“1143细菌内毒素检查法”进行实验,用家兔法对三批依托泊苷脂质微球注射液进行热原检查,使用湛江安度斯生物有限公司和福州新北生化工业有限公司两个不同厂家生产的鲎试剂对三批依托泊苷脂质微球注射液进行细菌内毒素干扰和检查实验。结果依托泊苷脂质微球注射液三批样品,每只家兔体温升高均低于0.6℃,3只家兔体温升高的总和均低于1.3℃,热原检查实验结果均符合规定。三批样品以60%乙醇溶解并稀释到0.03 mg/ml浓度,对细菌内毒素检查法无干扰作用。并进行细菌内毒素检查,结果符合规定。结论依托泊苷脂质微球注射液的热原及细菌内毒素检查方法可行,能控制产品质量,保证临床用药安全。Objective To test the pyrogen and bacterial endotoxin in etoposide-loaded lipid microsphere injection,and to formulate the control standards of pyrogen and bacterial endotoxin,so as to ensure product quality and medication safety.Methods Experiments were carried out according to"<9301>guideline for the application of injection safety test""<1142>pyrogen test"and"<1143>bacterial endotoxin test"in the 2015 edition of the Pharmacopoeia of the People’s Republic of China(Volume IV).Three batches of etoposideloaded lipid microsphere injection were inspected for pyrogen by rabbit method,and the interference and inspection tests for bacterial endotoxin in the three batches of etoposide-loaded lipid microsphere injection were carried out by using the tal reagents produced by two different manufacturers,namely Zhanjiang A&C Biological Ltd.and Fuzhou Xinbei Biochemical Industrial Co.,Ltd.Results After injected with three batches of samples of etoposide-loaded lipid microsphere injection,the increase in body temperature of each rabbit was less than 0.6℃,and the sum of the increase in body temperature of three rabbits was less than 1.3℃,indicating that the results of the pyrogen test met the requirements.When dissolved in 60%ethanol and diluted to a concentration of 0.03 mg/ml,the three batches of samples did not interfere with the bacterial endotoxin test method.The bacterial endotoxin test was carried out,and the results met the requirements.Conclusion The methods for testing pyrogen and bacterial endotoxin in etoposide-loaded lipid microsphere injection are feasible and can control the product quality and ensure medication safet y in clinic.

关 键 词：依托泊苷脂质微球注射液 热原检查 细菌内毒素检查法 鲎试剂 干扰实验 

分 类 号：R927.2[医药卫生—药学]