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目的:探讨细菌内毒素检查方法对注射用硫普罗宁钠进行检查的可行性。方法:根据《中国药典》2010年版二部细菌内毒素检查方法,采用凝胶法,通过灵敏度复核试验和干扰预试验,用标示灵敏度为0.25 EU.ml-1的鲎试剂和浓度为0.333 mg.ml-1的注射用硫普罗宁钠进行干预试验和内毒素检查。结果:注射用硫普罗宁钠浓度为0.333 mg.ml-1时对鲎试剂与细菌内毒素的凝集反应无干扰作用。结论:注射用硫普罗宁钠可用细菌内毒素检查法进行检查。
Objective: To investigate the feasibility of bacterial endotoxin test for the detection of tiopronin sodium for injection. Methods: According to the bacterial endotoxin test method of 2010 Chinese Pharmacopoeia (2010 edition), gel method, sensitivity test and interference pre-test were used. The calibration curve was 0.25 EU.ml-1 and the concentration was 0.333 mg. ml-1 injection of tiopronin for intervention trials and endotoxin tests. Results: The concentration of tiopronin sodium for injection was 0.333 mg.ml-1, there was no interference with the agglutination reaction of limulus agents and bacterial endotoxin. Conclusion: Tiopronin sodium for injection can be examined by bacterial endotoxin test.