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目的:考察穿琥宁注射液的细菌内毒素检查法的可行性,以代替热原检查法。方法:按《中国药典》(2010年版二部)附录细菌内毒素检查法。结果:穿琥宁注射液经过30倍稀释后,对鲎试剂的凝聚反应无干扰作用,选用标示灵敏度为0.5 EU/m L的鲎试剂检测细菌内毒素的方法可行,有效。结论:可以采用细菌内毒素检查法代替家兔法检测穿琥宁注射液的热源检查。
Objective: To investigate the feasibility of bacterial endotoxin test of Chuanhuning injection instead of pyrogen test. Methods: According to “Chinese Pharmacopoeia” (2010 edition two) appendix bacterial endotoxin test. Results: Chuanhuning injection had no interference with the agglutination reaction of 鲎 reagent after 30 times dilution. The method of detecting the bacterial endotoxin with 标 reagent with the labeling sensitivity of 0.5 EU / m L was feasible and effective. Conclusion: The bacterial endotoxin test can be used instead of the rabbit test to detect the heat source of Chuanhuning injection.