兰州大学学报（医学版）
蘭州大學學報（醫學版）
란주대학학보（의학판）
JOURNAL OF LANZHOU UNIVERSITY(MEDICAL SCIENCES)
2009年
2期
47-50
,共4页
李红芳%陈继军%王建军%王伟%杨博涵%李守丽%邹勇
李紅芳%陳繼軍%王建軍%王偉%楊博涵%李守麗%鄒勇
리홍방%진계군%왕건군%왕위%양박함%리수려%추용
乙型脑炎%减毒活疫苗%细菌内毒素%热原检查法
乙型腦炎%減毒活疫苗%細菌內毒素%熱原檢查法
을형뇌염%감독활역묘%세균내독소%열원검사법
encephalitis B virus%live-attenuated vaccine%bacterial endotoxin%pyrogen test
目的 建立乙型脑炎减毒活疫苗细菌内毒素检测的方法及质量标准.方法 参照<中华人民共和国药典>(三部)中细菌内毒素检查法检测,并与家兔热原实验结果进行对比.结果 使用凝胶限量法检测乙型脑炎减毒活疫苗细菌内毒素,限值为40 EU/mL,即将样品稀释至160倍,在该稀释度下样品对试验没有干扰.结论 该方法简便、灵敏、结果可靠,可用于乙型脑炎减毒活疫凿中间产品的细菌内毒素检查.
目的 建立乙型腦炎減毒活疫苗細菌內毒素檢測的方法及質量標準.方法 參照<中華人民共和國藥典>(三部)中細菌內毒素檢查法檢測,併與傢兔熱原實驗結果進行對比.結果 使用凝膠限量法檢測乙型腦炎減毒活疫苗細菌內毒素,限值為40 EU/mL,即將樣品稀釋至160倍,在該稀釋度下樣品對試驗沒有榦擾.結論 該方法簡便、靈敏、結果可靠,可用于乙型腦炎減毒活疫鑿中間產品的細菌內毒素檢查.
목적 건립을형뇌염감독활역묘세균내독소검측적방법급질량표준.방법 삼조<중화인민공화국약전>(삼부)중세균내독소검사법검측,병여가토열원실험결과진행대비.결과 사용응효한량법검측을형뇌염감독활역묘세균내독소,한치위40 EU/mL,즉장양품희석지160배,재해희석도하양품대시험몰유간우.결론 해방법간편、령민、결과가고,가용우을형뇌염감독활역착중간산품적세균내독소검사.
Objective To establish the inspection methods and quality criteria for bacterial en- dotoxin of live-attenuated vaccine of encephalitis B virus. Methods The inspecting method for bacterial endotoxin from Pharmacopoeia of the People's Republic of China (3 ed) was employed and the results were compared with the results of rabbit pyrogen test. Results Bacterial endo- toxin of live-attenuated vaccine of encephalitis B virus was detected by gel-clot limit test,the detection limit was 40 EU/mL,namely,160-fold dilution of the sample. In this dilution,no inter- ference of samples to the endotoxin test was observed. Conclusion The method is convenient, sensitive and reliable and may be used for bacterial endotoxin inspection of intermediate products of live-attenuated vaccine of encephalitis B virus.
