【摘要】 目的 考察了35批注射用盐酸阿霉素的细菌内毒素检查法可行性。 方法 《中国药典》2000年版细菌内毒素检查法。 结果 本品浓度大于2.5mg/ml有干扰作用。 结论 只要把检品稀释为2.5mg/ml选用灵敏度为0.5EU/ml的鲎试剂可用细菌内毒素检查。

    【关键词】 注射用盐酸阿霉素;细菌内毒素;鲎试剂;热原;抑制/增加试验

    Study on BET feasibility of doxorubicin hydrochloride with LAL

    LIU Jian-guo，YUANHui-de，CHEN Xiang-yun，et al.

    Zhejiang Taizhou Prefectural Institute for Drug Control，Zhejinag318000，China

    【Abstract】 Objective To inspect on the feasibility of bacterial endotoxin test(BET)for thirty-five batches of doxorubicin hydorchloride for Inj.Methods BET of China pharmacopoeia.Results Interferential effect was shown on the density above2.5mg/ml.Conclusion The dilution of2.5mg/ml could be tested by limulus amebocyte lysate with the sensitivity of0.5EU/ml.

    【Key words】 dexorubicin hydrochloride for inj;bacterial endotoxin;limulus amebocyte lysate(LAL)inhibition/strengthen test;pyrogen

    注射用盐酸阿霉素 ......