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注射用头孢硫脒在室温下的稳定性研究

Stability of Cefathiamidine for injection

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【作者】 李明史天陆廖明

【Author】 LI Ming~1,SHI Tian-lu~2,LIAO Ming~3(1.Pharmacy Department of Affiliated Hospital of Guiyang Medical College,Guiyang 550004;Pharmacy Department of Anhui Provincial Hospital,Anhui 230001;Matermal and Child Health Hospital of Guiyang city,Guiyang 550003)

【机构】 贵阳医学院附属医院药剂科安徽省立医院药剂科贵阳市妇幼保健医院

【摘要】 目的:考察注射用头孢硫脒分别在室温(25℃)(样品1)和冰箱冷藏(0~8℃)(样品2)的储存条件下,药物溶液的配置前及配置后稳定性,为临床应用提供参考。方法:建立高效液相色谱法测定头孢硫脒的含量,连续测定5日内样品1和样品2头孢硫脒的含量,考察其在不同贮存条件下的配置前稳定性。并将头孢硫脒配置成输液形式,测定其1、1.5、2、24h后的含量,考察头孢硫脒的配置后稳定性。结果:样品1和样品2在五日内测得的浓度无显著性差异(p>0.05),但配置成输液后在1、1.5、2h内逐渐降解,24h后样品1和样品2分别降解了39.3%和29.7%。结论:短时间(≤5d)头孢硫脒在室温与冷藏条件下贮藏,其含量无明显变化,患者可安全使用。头孢硫脒配置后稳定性差,临床应现用现配。

【Abstract】 Objective To study the before and after configuration stability of Cefathiamidine for injection at different storage conditions for clinical references:Sample 1 is keep at room temperature(25℃),Samplef 2 is keep at refrigerator(0~8℃).Methods:Determine the cefathiamidine content of Sample 1 and Sample 2 by a HPLC method in continuous 5 days,in order to compare the before configuration stability at different storage conditions.And determine the cefathiamidine content of configuration after 1、1.5、2、24h to study the after configuration stability.Results:The cefathiamidine content of Sample 1 and Sample 2 are no obvious difference(p>0.05).However,the content is degrated gradually after configurating 1、1.5、2h,Sample 1 and Sample 2 were degrated 39.3% and 29.7%after 24h.Conclusion:No significant changes in cefathiamidme content at different storage conditions between room temperature and refrigerator in short days(≤5d).But the stability is poor after configuration,so clinical should hand-to-mouth match the cefathiamidine.

  • 【会议录名称】 2013年中国临床药学学术年会暨第九届临床药师论坛论文集
  • 【会议名称】2013年中国临床药学学术年会暨第九届临床药师论坛
  • 【会议时间】2013-06-14
  • 【会议地点】中国江西南昌
  • 【分类号】R944
  • 【主办单位】中国医院协会药事管理专业委员会
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