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)