动态浊度法评价一次性无菌注射器及塑料容器对细菌内毒素的吸附

Evaluation of Bacterial Endotoxin Adhesion by Disposable Sterile Syringes and Plastic Containers by Kinetic Turbidimetric Limulus Method

目的评价一次性注射器及塑料容器对细菌内毒素是否存在吸附,为药品检验提供依据。方法采用动态浊度法测定2个规格的一次性注射器和塑料储存容器(无热原塑料离心管、一次性塑料细胞培养瓶)与标准内毒素溶液共存后标准内毒素溶液的内毒素含量。结果一次性注射器与标准细菌内毒素共存30,120 min后,均未见标准内毒素浓度的降低;塑料存储容器与标准内毒素共存后,7 h之内,均未见标准内毒素浓度的降低,30,48 h两个测定时点,聚丙烯材料的离心管内标准内毒素浓度均呈降低趋势,聚苯乙烯材料的细胞培养瓶内标准内毒素浓度未见明显降低。结论热原日常检验中采用一次性无菌注射器,抽药液后2 h内完成注射,不会影响污染内毒素产品的检出;采用聚丙烯材料的一次性无热原器具稀释细菌内毒性检查样品时,应在7 h内完成;聚苯乙烯产品较聚丙烯产品细菌内毒素吸附较低。

Objective To evaluate the adhesion of bacterial endotoxin by disposable syringes and plastic containers and to provide evidence for drug test.Methods The endotoxin content of the standard endotoxin was detected by kinetic turbidimetric limulus method after coexistence with two specifications of disposable syringes and plastic storage containers(pyrogen free plastic centrifuge tube,disposable plastic cell culture bottle).Results After coexistence with disposable sterile syringes for 30 min or 2 h,no decrease of the endotoxin content of standard bacterial endotoxin solution was observed.After coexistence with plastic storage containers,no decrease of the endotoxin content of standard bacterial endotoxin solution within 7 h was observed;after coexistence with polypropylene centrifuge tube for 30 h or 48 h,the endotoxin content of standard endotoxin solution showed tendency of decrease,while the endotoxin content of standard endotoxin solution in polypropylene cell culture bottle showed no significant decrease.Conclusion The injection using disposable sterile syringes in daily pyrogen test should be completed within 2 h after the withdrawal of drug liquid.The dilution of the sample by the disposable pyrogen free apparatus made of polypropylene material should be completed within 7 h.The adhesion of polystyrene products with bacterial endotoxin is lower than that of polypropylene products.