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目的:建立注射用醋酸卡泊芬净细菌内毒素检测方法,研究其方法中产生假阳性干扰的因素。方法:按照《中国药典:四部》(2015版)通则《1 143细菌内毒素检查法》要求,采用两家试剂厂生产的鲎试剂对注射用醋酸卡泊芬净进行凝胶反应干扰试验研究。结果:通过细菌内毒素干扰试验,证实采用Tris缓冲试剂后假阳性现象消失。结论:注射用醋酸卡泊芬净是可以采用细菌内毒素检查法(凝胶反应)控制其产品质量;采用Tris试剂排除注射用醋酸卡泊芬净凝胶限度试验检测时的假阳性干扰,方法具有灵敏、快速、准确的特点。
OBJECTIVE: To establish a method for the detection of bacterial endotoxin in caspofungin acetate for injection and to study the factors that cause false-positive interference in its method. Methods: According to the “1 143 Bacterial Endotoxin Test Method” of “Chinese Pharmacopoeia (4)” (2015 edition), the interference reaction of caspase-ampicillin acetate gel for injection was studied by using the 鲎 reagent produced by two reagent factories. Results: Bacterial endotoxin interference test confirmed the false positive phenomenon disappeared with Tris buffer reagent. CONCLUSIONS: Caspofungin acetate for injection is able to control the quality of its products using the bacterial endotoxin test (gel reaction); the use of Tris reagent to exclude false positive interferences during caspofungin acetate gel limit testing With sensitive, fast, accurate features.