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不同生产厂家乳酸环丙沙星注射液质量考察
引用本文:王丽荣,庞青云,王俊秋,周立春,余立.不同生产厂家乳酸环丙沙星注射液质量考察[J].中国药房,2007,18(16):1247-1248.
作者姓名:王丽荣  庞青云  王俊秋  周立春  余立
作者单位:北京市药品检验所,北京市,100035
摘    要:目的:比较不同厂家乳酸环丙沙星注射液的质量。方法:对国内、外4厂家产品的不溶性微粒、乳酸含量、乙二胺及有关物质、容器内表面吸附性能进行测定或观察。结果:所有被测产品各项指标均符合《中国药典》要求,除不溶性微粒外,其余指标不同厂家产品之间存在差异。结论:有必要对乳酸环丙沙星注射液中部分项目进行限量规定。

关 键 词:乳酸环丙沙星注射液  乙二胺  检测  质量  比较
文章编号:1001-0408(2007)16-1247-02
收稿时间:2006-12-31
修稿时间:2006-12-312007-03-14

Investigation on Quality of Ciprofloxacin Lactate Injection from Different Manufacturers
WANG Lirong,PANG Qingyun,WANG Junqiu,ZHOU Lichun,YU Li.Investigation on Quality of Ciprofloxacin Lactate Injection from Different Manufacturers[J].China Pharmacy,2007,18(16):1247-1248.
Authors:WANG Lirong  PANG Qingyun  WANG Junqiu  ZHOU Lichun  YU Li
Institution:Beijing Institute for Drug Control, Beijing 100035, China
Abstract:OBJECTIVE:To compare the quality of ciprofloxacin lactate injections from different manufactories.METHODS:The determination of ciprofloxacin lactate injections from 4 different manufacturers was performed from several aspects:particulate matter,lactic acid content,ethanediamine,the related substance and the superficial adsorption property within container was determined.RESULTS:The determined indexes of all ciprofloxacin lactate injection products manufactured by 4 different manufacturers were all in line with the specification of China Pharmacopoeia,with all of the indexes except the index of particulate matter showing no difference.CONCLUSION:The results suggest that it is necessary to define a limited dose for some items in ciprofloxacin lactate injection.
Keywords:Ciprofloxacin lactate injection  Ethanediamine  Determination  Quality  Comparison
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