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盐酸普罗帕酮注射液细菌内毒素检查方法的确立
引用本文:石庆平,张大萍,邢蓉. 盐酸普罗帕酮注射液细菌内毒素检查方法的确立[J]. 蚌埠医学院学报, 2003, 28(3): 267-268
作者姓名:石庆平  张大萍  邢蓉
作者单位:蚌埠医学院附属医院,药剂科,安徽,蚌埠,233004
摘    要:目的:验证盐酸普罗帕酮注射液细菌内毒素检查法的可行性。方法:通过抑制/增强试验确定盐酸普罗帕酮注射液的有效稀释浓度和细菌内毒素限值。结果:0.35mg/ml的盐酸普罗帕酮溶液无干扰作用,其内毒素限值符合规定。结论:盐酸普罗帕酮注射液可用细菌内毒素检查法来控制其细菌内毒素含量。

关 键 词:盐酸普罗帕酮注射液 细菌内毒素检查 热源检查 有效稀释浓度
文章编号:1000-2200(2003)03-0267-02
修稿时间:2001-12-28

Test of bacterial endotoxin in propafenone hydrochloride injection
SHI Qing ping,ZHANG Da ping,XING Rong. Test of bacterial endotoxin in propafenone hydrochloride injection[J]. Journal of Bengbu Medical College, 2003, 28(3): 267-268
Authors:SHI Qing ping  ZHANG Da ping  XING Rong
Abstract:Objective:To verify the feasibility of bacterial endotoxins test in detecting propafenone hydrochloride injection.Methods:The valid concentration of propafenone hydrochloride injection and its bacterial endotoxin limit were determined by inhibiting/enhancing test.Results:Propafenone hydrochloride solution did not at the concentration 0.35 mg/ml interfere with bacterial endotoxin test and its endotoxin limit accords with the regulation.Conclusions:Bacterial endotoxin test can be used to control the content of bacterial endotoxin in propafenone hydrochloride injection. [
Keywords:propafenone  endotoxins  bacteria  inhibiting/enhancing test  tachyleus amebocyte lysate
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