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目的建立复方二氯醋酸二异丙胺氯化钠注射剂细菌内毒素检查法。方法通过灵敏度试验、干扰试验,确定复方二氯醋酸二异丙胺氯化钠注射剂细菌内毒素检查法的条件。结果复方二氯醋酸二异丙胺氯化钠注射剂经16倍稀释后,用灵敏度为0.25EU/ml的鲎试剂检查细菌内毒素无干扰因素的影响。结论用细菌内毒素检查法检查复方二氯醋酸二异丙胺氯化钠注射剂是可行的。
Objective To establish a bacterial endotoxin test for Compound Dichloroacetic Acid Diisopropylamine Sodium Chloride Injection. Methods The sensitivity test and interference test were used to determine the bacterial endotoxin test of Compound Dichloroacetic Acid Diisopropylamine Sodium Chloride Injection. Results Compound Dichloroacetic acid diisopropylamine sodium chloride injection after 16-fold dilution, with a sensitivity of 0.25EU / ml of 鲎 reagent to check the bacterial endotoxin-free interference factors. Conclusions It is feasible to use compound endotoxin test to examine compound Dichloroacetic acid and diisopropylamine sodium chloride injection.