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目的:对硫酸异帕米星注射液进行凝胶法干扰试验,建立硫酸异帕米星注射液细菌内毒素检查法的试验方法。方法:采用中国药典2005年版二部附录细菌内毒素检查法。用不同厂家的鲎试剂对不同批号的样品分别进行干扰试验,考察确定样品细菌内毒素检测法。结果:采用灵敏度为0.5EU.mL--1的鲎试剂,将本品稀释75倍,对鲎试剂与内毒素的凝集反应无干扰。结论:本品可用内毒素检查取代热原检查。其细菌内毒素限值可定为0.25EU.mg-1。
OBJECTIVE: To establish a method of bacterial endotoxin test for ispazamic acid injection by gel-method interference test of isoproterenol sulfate injection. Methods: The Chinese Pharmacopoeia 2005 edition two appendix bacterial endotoxin test. Different manufacturers of 鲎 reagent for different batches of samples were interference test to determine the sample to determine the bacterial endotoxin test. Results: The sensitivity of 0.5EU.mL - 1 鲎 reagent, the product diluted 75 times, the 鲎 reagent and endotoxin agglutination reaction without interference. Conclusion: This product can replace the pyrogen test with endotoxin test. Bacterial endotoxin limit may be set at 0.25EU.mg-1.