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目的 :建立氢化可的松注射液的细菌内毒素 (ETX)检查法。方法 :根据《中国药典》1995年版二部收载的细菌内毒素检查法的要求进行实验。结果 :将氢化可的松注射液经 15倍稀释后可排除干扰因素 ,用标示灵敏度为 0 5Eu/ml的鲎试剂检测细菌内毒素是有效的。结论 :氢化可的松注射液的热原检查可用细菌内毒素法。
Objective: To establish a bacterial endotoxin (ETX) test for hydrocortisone injection. Methods: According to the requirements of the bacterial endotoxin test method contained in the 1995 edition of Chinese Pharmacopoeia. Results: The 15-fold dilution of hydrocortisone injection could eliminate the interference factors and the detection of bacterial endotoxins by the limulus reagent with labeling sensitivity of 0 5Eu / ml was effective. Conclusion: The pyrogen test of hydrocortisone injection can be used bacterial endotoxin method.