烧伤膏细菌内毒素检查方法学研究  

Study on gelation clotmethod of bacterial endotoxin test in the burn ointment

作　　者：曹霞飞 何华红[2] 吴婷[2] 李志芳[2] CAO Xiafei;HE Huahong;WU Ting;LI Zhifang(Guangzhou Institute For Food Inspection,Guangzhou 511405,China;Guangzhou Drug Inspection Institute,Guangzhou 510160,China)

机构地区：[1]广州市食品检验所,广东广州511405 [2]广州市药品检验所,广东广州510160

出　　处：《中国医药科学》2018年第19期65-68,共4页China Medicine And Pharmacy

摘　　要：目的探讨湿润烧伤膏经正己烷萃取后水溶液的细菌内毒素检查方法。方法采用外加定量内毒素接种法,将烧伤膏内毒素从油相中萃取到水相中,用动态浊度法测定内毒素回收率,考察萃取过程中对内毒素的影响;同时用凝胶法对不干扰浓度做进一步验证。结果萃取液稀释6倍后的内毒素回收率为52.3%且对鲎试剂反应无干扰,两种方法检测萃取液中内毒素的结果均在规定限值内。结论湿润烧伤膏用正己烷溶解后,与细菌内毒素检查用水充分振荡混匀,取水相萃取液进行细菌内毒素检查是可行的。Objective To investigate the bacterial endotoxin test method of n-hexane extraction in aqueous solution of wet burn ointment. Methods Extraction of endotoxin from oil form to water form by adding quantitative endotoxin inoculation. The recovery rate of endotoxin was measured by kinetic turbidimetrie method,and the influence of extraction process on endotoxin was investigated. Meanwhile,the non-interference concentration was further verified by gel method. Results The recovery rate of endotoxin is 52.3% after 6 times dilution of the extract and there was no interference with the guanidine reagent reaction.The results of the two methods for detecting endotoxin in the extract were within the prescribed limits. Conclusion Wet burn ointment dissolved with n-hexane,fully oscillated and mixed with bacterial endotoxin test water,and it is feasible to take water phase extract for bacterial endotoxin test.

关 键 词：烧伤膏 细菌内毒素 动态浊度法 干扰试验 

分 类 号：R473.6[医药卫生—护理学]