《中国药典》2020年版蛋黄卵磷脂细菌内毒素检测  

Study on bacterial endotoxin detection of egg yolk lecithin of Chinese Pharmacopoeia 2020 Edition

作　　者：裴宇盛 赵小燕 陈晨 高华 蔡彤 PEI Yu-sheng;ZHAO Xiao-yan;CHEN Chen;GAO Hua;CAI Tong(Division of Pharmacology,Institute for Chemical Drug Control,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院化学药品检定所药理室,北京102629

出　　处：《中国药理学通报》2022年第8期1227-1230,共4页Chinese Pharmacological Bulletin

基　　金：国家科技重大专项(No.2018ZX09101001);国家药典委员会药品标准制修订研究课题(No.2020Y007)。

摘　　要：目的解决蛋黄卵磷脂内毒素检测方法应用中的问题,研究建立蛋黄卵磷脂(供注射用)的细菌内毒素检查方法。方法取吐温80的乙醇溶液(吐温80∶无水乙醇=2.5 g∶2.7 mL,混匀4 min)配制0.1 kg·L^(-1)的蛋黄卵磷脂溶液,制备供试品溶液时,取1 mL蛋黄卵磷脂溶液加入检查用水10μL(供试品阳性对照加入5×10^(5) EU·L^(-1)的内毒素标准溶液10μL),用内毒素检查用水稀释20倍后,用动态浊度法检测,标准曲线范围10~10 EU·L^(-1)。使用2个厂家的鲎试剂对8批样品进行了内毒素检查的方法学研究。结果8批样品的回收率均符合药典中规定的50%~200%之间,符合干扰试验要求,解决了目前的内毒素检查法在实际应用中的问题。结论建立了具有较好耐用度的蛋黄卵磷脂细菌内毒素检查方法,为药典修订提供依据。Aim To solve the problems in the application of egg yolk lecithin endotoxin test method,and and to establish the bacterial endotoxin examination method for egg yolk lecithin(for injection).Methods The ethanol solution of Tween 80(the volume ratio of tween 80 to anhydrous ethanol was 2.5∶2.7,mixed for 4 min)was used to prepare lecithin solution of egg yolk at 0.1 kg·L^(-1),and 10μL test water was added to 1 mL lecithin solution of egg yolk(500 EU·mL^(-1) standard solution of endotoxin 10μL was added for positive control).After diluted 20 times with endotoxin test water,the standard curve range was 10~0.01 EU·mL^(-1) by kinetic-turbidimetric assay.Methodology of endotoxin test was studied using limulus lysate from two manufacturers and eight batches of samples.Results The recoveries of eight batches of samples all met the requirement of interference test between 50%and 200%stipulated in the pharmacopoeia,which solved the problems of the current endotoxin test method in practical application.Conclusions The bacterial endotoxin test method of egg yolk lecithin with good durability is established to provide the basis for the revision of pharmacopoeia.

关 键 词：蛋黄卵磷脂 吐温80 无水乙醇 动态浊度法 中国药典 细菌内毒素 干扰试验 

分 类 号：R-61[医药卫生] R155.56R344.51R996