摘要
目前脂质体中内毒素的检测存在三个技术难点。一是从脂质体中提取细菌内毒素;二是如何在回收试验中加入内毒素;三是消除药物和辅料对试验的干扰。针对上述问题,本文报道了紫杉醇脂质体检测细菌的关键技术,用乙醇溶解脂质体提取细菌内毒素。用0.01 m L标准内毒素加到1 m L脂质体乙醇溶液中制备回收试验中的样品阳性对照溶液。用0.5%人白蛋白消除了检测干扰,准确测定了脂质体中的内毒素。
Based on current research, there are three technologies during the test of bacterial endotoxin of liposomes：（1） extraction of bacterial endotoxin from liposomes;（2） addition of bacterial endotoxin in the process of recovery test; and（3） elimination of the interference factors from drugs and excipients. In the present study, we pointed out that the key technologies to test bacterial endotoxin from paclitaxel liposome included following steps： extraction of bacterial endotoxins from ethanol-dissolved liposomes; preparation of positive control of recovery solution by adding 0.01 m L standard endotoxins in 1 m L liposome ethanol solution; and the use of 0.5% human albumin to eliminate the interference from detection, and accurate detection of the bacterial endotoxin of liposomes.
作者
裴宇盛
蔡彤
张国来
陈晨
高华
Yusheng Pei;Tong Cai;Guolai Zhang;Chen Chen;Hua Gao(National Institutes for Food and Drug Control,Beijing 102629,China)
基金
The National Major Scientific and Technological Special Project for"Significant New Drugs Development"of China(Grant No.2015ZX09303001)
Sub-task"study on methods for detection and evaluation of pyrogen substances in new preparations"(Grant No.2015ZX093030012002)
