泊沙康唑原料细菌内毒素检查方法的建立  

Establishment of Bacterial Endotoxin Test Method for Posaconazole Raw Material

作　　者：耿雪 南红燕 范治云 刘娜 祝清芬 李军 GENG Xue;NAN Hong-yan;FAN Zhi-yun;LIU Na;ZHU Qing-fen;LI Jun;无(NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Shandong Research Center of Engineering and Technology for Consistency Evaluation of Generic Drugs,Shandong Institute for Food and Drug Control,Jinan 250101,China;Shandong Jincheng Pharmaceutical Research Institute Co.,Ltd.,Zibo 255000,China)

机构地区：[1]山东省食品药品检验研究院国家药品监督管理局仿制药研究与评价重点实验室山东省仿制药一致性评价工程技术研究中心,山东济南250101 [2]山东金城医药研究院有限公司,山东淄博255000

出　　处：《食品与药品》2022年第3期278-281,共4页Food and Drug

摘　　要：目的建立泊沙康唑原料细菌内毒素检查法。方法根据泊沙康唑注射液临床用量计算得泊沙康唑的内毒素限值为1.0 EU/mg,从严制订限值为0.5 EU/mg。以四氢呋喃-吐温80(4:1)为溶剂溶解泊沙康唑原料,用细菌内毒素检查用水(BET水)稀释后按《中国药典》2020年版四部通则1143细菌内毒素检查法,使用两个厂家的鲎试剂对3批供试品进行细菌内毒素凝胶法干扰试验,并进行3批供试品的细菌内毒素检查。结果3批供试品在1 mg/ml及以下浓度时对试验均无干扰作用,可覆盖所有目前市售鲎试剂灵敏度范围。3批供试品细菌内毒素检查结果均符合规定。结论泊沙康唑原料可采用细菌内毒素检查法进行质量控制。Objective To establish the bacterial endotoxin test method for posaconazole raw material.Methods According to the clinical dose of Posaconazole Injection,the endotoxin limit of posaconazole raw material was calculated as 1.0 EU/mg,which was strictly limited to 0.5 EU/mg.The sample was dissolved with tetrahydrofuran-twain 80(4:1),and diluted with bacterial endotoxin test(BET)water.According to Bacterial Endotoxins Test listed in General Rule 1143 of Chinese Pharmacopoeia 2020(Part IV),the bacterial endotoxin gel-clot interference test of three batches of samples from two manufacturers was carried out.Bacterial endotoxin test of three batches of samples were also conducted.Results Three batches of test samples have no interference effect on the test at the concentration of 1 mg/ml or below,which could cover the sensitivity range of all commercially available limulus agents.The bacterial endotoxin test results of three batches of samples were all in line with the requirements.Conclusion The quality of posaconazole raw material can be monitored by bacterial endotoxin test(gel-clot method).

关 键 词：泊沙康唑 细菌内毒素 原料 方法学研究 

分 类 号：R927.12[医药卫生—药学]