中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2014年
17期
39-40,41
,共3页
祝清芬%逯传凤%魏霞%张娟%郝玲玲
祝清芬%逯傳鳳%魏霞%張娟%郝玲玲
축청분%록전봉%위하%장연%학령령
乙醇%细菌内毒素检查%动态浊度法
乙醇%細菌內毒素檢查%動態濁度法
을순%세균내독소검사%동태탁도법
alcohol%bacterial endotoxins test%kinetic turbidimetric test
目的:采用动态浊度法研究乙醇对细菌内毒素检查法的影响。方法按2010年版《中国药典(二部)》,建立4个浓度点的标准曲线,采用干扰试验方法,通过测定不同浓度的乙醇对外加内毒素的回收率,研究其对细菌内毒素检查试验的干扰情况。结果标准曲线回归方程相关系数绝对值为0.9886(应大于或等于0.980),标准曲线成立。供试液中乙醇浓度浓度为5%及以下时外加细菌内毒素的回收率在50%~200%范围内。结论乙醇在浓度为5%或以下时对细菌内毒素检查法无干扰作用。
目的:採用動態濁度法研究乙醇對細菌內毒素檢查法的影響。方法按2010年版《中國藥典(二部)》,建立4箇濃度點的標準麯線,採用榦擾試驗方法,通過測定不同濃度的乙醇對外加內毒素的迴收率,研究其對細菌內毒素檢查試驗的榦擾情況。結果標準麯線迴歸方程相關繫數絕對值為0.9886(應大于或等于0.980),標準麯線成立。供試液中乙醇濃度濃度為5%及以下時外加細菌內毒素的迴收率在50%~200%範圍內。結論乙醇在濃度為5%或以下時對細菌內毒素檢查法無榦擾作用。
목적:채용동태탁도법연구을순대세균내독소검사법적영향。방법안2010년판《중국약전(이부)》,건립4개농도점적표준곡선,채용간우시험방법,통과측정불동농도적을순대외가내독소적회수솔,연구기대세균내독소검사시험적간우정황。결과표준곡선회귀방정상관계수절대치위0.9886(응대우혹등우0.980),표준곡선성립。공시액중을순농도농도위5%급이하시외가세균내독소적회수솔재50%~200%범위내。결론을순재농도위5%혹이하시대세균내독소검사법무간우작용。
Objective To investigate the effects of alcohol on the bacterial endotoxin test by the kinetic turbidimetric method. Methods According to the Chinese Pharmacopoeia ( 2010 version, Part 2 ) , the standard curve with 4 concentration points were established. The in-terfering test was adopted to investigate the interference situation on the bacterial endotoxin test by measuring the recovery rate of dif-ferent concentrations of ethanol on the added endotoxin. Results The absolute value of the correlation coefficient of the standard curve regression equation was 0. 988 6 ( should greater than or equal to 0. 980 ) , the standard curve was established. The recovery rate of the added endotoxin in the sample solution was in the range of 50% -200% when the alcohol concentration was 5% or less. Conclusion Alcohol has no interference on the bacterial endotoxins test when the alcohol concentration was 5% or less.