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[摘要]
目的 建立测定红花黄素注射液细菌内毒素的方法。方法 通过进行红花黄素注射液的干扰试验考察,对30批红花黄素注射液进行了热源检查和细菌内毒素检查的对比试验。结果 红花黄素注射液对细菌内毒素检查法鲎试剂反应没有干扰作用,可以用鲎试剂法作内毒素检查。且本法的结果与家兔法检查热源的结果比较,符合率为10 0 %。结论 方法简便、快速、准确。用本方法检测红花黄素注射液中的细菌内毒素是可行的。
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[Abstract]
Object To establish a method for the determination of bacterial endotoxin in SAFFLOR INJECTION.Methods Thirty batches of SAFFLOR INJECTION were subjected to Limulus lysate test in comparison with pyrogen test to ascertain whether there are any interference between the lysate and SAFFLOR INJECTION.Results SAFFLOR INJECTION showed no inhibition or enhancement actions in bacterial endotoxin test with Limulus lysate, while showed a 100% coincidental rate with pyrogen test.Conclusion This method was found to be simple, quick, accurate and is suitable for the determination of bacterial endotoxin in SAFFLOR INJECTION.
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