中国药典_____醋酸亮丙瑞林；细菌内毒素；干扰试验

醋酸亮丙瑞林细菌内毒素检查法研究报告

http://www.100md.com 《广东药学院学报》 2004年第1期

中国药典,,醋酸亮丙瑞林；细菌内毒素；干扰试验,1实验材料,2实验方法及结果,3结语

     摘要依据《中国药典》2000年版二部“细菌内毒素检查法”及“细菌内毒素检查法应用指导原则”，并参照《英国药典》2000年版的要求，确定试验样品醋酸亮丙瑞林的细菌内毒素限值为16.7 EU/mg。经对广西半宙制药有限公司生产的三批醋酸亮丙瑞林采用细菌内毒素检查法中的凝胶法进行干扰试验，确证样品的最大无干扰浓度为15 μg/mL。

    关键词醋酸亮丙瑞林；细菌内毒素；干扰试验

    Study on the gelation method of bacterial endotoxin tests in

    leupropelin acetate

    WU Zhiqiang WEI Qizhi

    (Guangxi Institute For Drug Control,Nanning,Guangxi 5300219)

    Abstract Objective: To establish a gelation method of bacterial endotoxin tests for leupropelin acetate. Methods: The maximum nondisturbing concentration was obtained according to interference test for the substances being examined. Results and conclusion: Leupropelin could interfere the detection of bacterial endotoxin. When the concentration of the substance being examined was diluted to 15μg/ml, the interference between the sample and the TAL regent can be eliminated.

    Key words leupropelin acetate; bacterial endotoxin; interference test

    醋酸亮丙瑞林是《英国药典》2000年版收载的品种 ......

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