盐酸多柔比星脂质体注射液热原检查方法学验证  

Validation of Pyrogen Test Method for Doxorubicin Hydrochloride Liposome Injection

作　　者：蒙宏 朱社敏 张文婷 杜明阳 匡荣 MENG Hong;ZHU She-min;ZHANG Wen-ting;DU Ming-yang;KUANG Rong(Zhejiang Institute for Food and Drug Control,NMPA Key Laboratory for Animal Alternative Testing Technology of Cosmetics,Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province,Hangzhou 310052,china;Zhejiang Zhida Pharmaceutical Co.,Ltd.,Shaoxing 312086,china)

机构地区：[1]浙江省食品药品检验研究院/国家药品监督管理局化妆品动物替代试验技术重点实验室/浙江省药品接触材料质量控制研究重点实验室,浙江杭州310052 [2]浙江智达药业有限公司,浙江绍兴312086

出　　处：《海峡药学》2023年第11期33-35,共3页Strait Pharmaceutical Journal

摘　　要：目的验证盐酸多柔比星脂质体注射液热原检查方法的适用性,制定热原检查质量标准。方法参考《中国药典》2020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”进行热原检查方法学验证,并对3批盐酸多柔比星脂质体注射液进行热原检查。结果盐酸多柔比星脂质体注射液(10 mL∶20 mg)按2.8 mL·kg^(-1)给药时对家兔热原检查无干扰,3批样品热原检查结果均符合规定。结论可采用家兔热原检查法检查盐酸多柔比星脂质体注射液中可能存在的热原,给药剂量为2.8 mL·kg^(-1)。OBJECTIVE To explore the applicability of pyrogen test on Doxorubicin hydrochloride liposome injection.METHODS Refer to the“guiding principles for the application of 9301 injection safety inspection method”and“1142 pyrogen inspection method”in the fourth volume of Chinese Pharmacopoeia,2020 edition,to verify the pyrogen inspection methodology,and conduct pyrogen inspection on three batches of doxorubicin hydrochloride liposome injection.RESULTS Doxorubicin hydrochloride liposome injection(10 mL∶20 mg)did not interfere with the pyrogen test of rabbits at 2.8 mL·kg^(-1),and the pyrogen test results of three batches of samples all met the requirements.CONCLUSION The rabbit pyrogen test can be used to detect the possible pyrogen in doxorubicin hydrochloride liposome injection at a dose of 2.8 mL·kg^(-1).

关 键 词：盐酸多柔比星脂质体注射液 热原检查 家兔 方法学验证 

分 类 号：R927[医药卫生—药学]