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目的 :确定注射用促肝细胞生长素 (HGF)可用细菌内毒素检查法代替传统的热原检查法。方法 :用鲎试剂和家兔热原法做对比。结果 :将注射用HGF稀释成 0 .2 5mg/ml,用灵敏度为 0 .12 5EU/ml的鲎试剂进行内毒素检查 ,能有效消除干扰。结论 :细菌内毒素检查法可以代替热原检查法 ,对HGF进行质量控制。
OBJECTIVES: To determine the use of hepatocyte growth-promoting hormone (HGF) injection can replace the traditional pyrogen test with bacterial endotoxin test. Methods: Contrast with 鲎 reagent and rabbit pyrogen method. Results: The injection of HGF diluted to 0.25mg / ml, with a sensitivity of 0.125EU / ml of 鲎 reagent endotoxin test, can effectively eliminate the interference. Conclusion: The bacterial endotoxin test can replace the pyrogen test to control the quality of HGF.