泊沙康唑原料药细菌内毒素检查方法研究  

Method for Bacterial Endotoxin Test of Posaconazole Active Pharmaceutical Ingredients

作　　者：张辉 黄有兴 王美娜 ZHANG Hui;HUANG Youxing;WANG Meina(Hainan Center for Drug and Medical Device Evaluation and Service,Haikou,Hainan,China 570216;Hainan Hailing Chemical Pharmaceutical Co.,Ltd.,Haikou,Hainan,China 570311)

机构地区：[1]海南省药品和医疗器械审评服务中心,海南海口570216 [2]海南海灵化学制药有限公司,海南海口570311

出　　处：《中国药业》2022年第12期94-97,共4页China Pharmaceuticals

基　　金：海南省海口市创新平台建设项目[2020-060]。

摘　　要：目的建立泊沙康唑原料药细菌内毒素的检查方法。方法依照2020年版《中国药典(四部)》通则1143细菌内毒素检查法,用N,N-二甲基甲酰胺溶解泊沙康唑,再用细胞内毒素检查用水(BET用水)稀释,采用凝胶法,用2个厂家的鲎试剂进行干扰试验和内毒素回收干扰验证试验,对泊沙康唑进行细菌内毒素检查。结果泊沙康唑先用2%的N,N-二甲基甲酰胺溶解,再用BET用水制备质量浓度≤0.833 mg/mL的供试品溶液时,对其细菌内毒素检查结果无影响。结论本研究中建立的细菌内毒素检查方法可行,可用于制剂生产中泊沙康唑原料药细菌内毒素的控制。Objective To establish a method for bacterial endotoxin test of posaconazole active pharmaceutical ingredients(API).Methods According to bacterial endotoxin test(BET)method in the general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),posaconazole was dissolved with N,N-dimethylformamide,diluted with BET water,the gel method was used to carry out interference test and endotoxin recovery interference verification test with limulus amebocyte lysate reagents from two manufacturers,and then the BET of posaconazole was performed.Results Posaconazole was dissolved with 2%N,N-dimethylformamide and then prepared into a test solution with a mass concentration≤0.833 mg/mL with BET water,which had no effect on the results of BET.Conclusion The BET method established in this study is feasible,which can be used to control the bacterial endotoxin of posaconazole API in the production of preparations.

关 键 词：泊沙康唑 细菌内毒素 干扰试验 质量控制 

分 类 号：R94[医药卫生—药剂学] R978.5[医药卫生—药学]