| 摘要: |
| 为了进一步为长效沙星(培氟沙星)注射液的临床应用提供依据,以二蒸水为溶剂,采用紫外-可见分光光度法,在190～400 nm波长范围内进行全波段扫描,以最大吸收波长确定为培氟沙星的测定波长,最后以光加速试验和经典恒温热加速试验考察了长效沙星注射液的稳定性。结果表明,培氟沙星的测定波长为274 nm,在2～10 μg/mL质量浓度范围内,长效沙星溶液的吸光度与其质量浓度之间有良好的线性关系,平均回收率为100.43%。长效沙星注射液对热稳定,对光不稳定,在避光、室温(25 ℃)条件下的有效期暂定为2年。 |
| 关键词: 长效沙星注射液 培氟沙星 稳定性 有效期 |
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| Studies on chemistry stability of pefloxacin injection |
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| Abstract: |
| Stability of pefloxacin injection was carried out in order to supply proof for clinic use of the injection.Pefloxacin injection was scanned by UV-Vis within 190-400 nm wavelength to determine the wavelength which can be used to measured pefloxacin in pefloxacin injection,with distilled water as menstruum.Then stability of pefloxacin injection was assessed through light accelerated testing and classical constant temperature accelerated testing.The results showed that content in pefloxacin injection could be measured by UV Vis at 274 nm.The calibration curve was linear in the concentration ranged 2-10 μg/mL（r=0.997 6，n=9）,equation of calibration curve was:C=0.146 2+11.276 9 A,and the method recoveries were 100.43%.The injection was stable for heat,but unstable for light.It could be forecasted that period of validity of the injection was two years under room-temperature (25 ℃) and away from light. |
| Key words: pefloxacin injection,pefloxacin,stability,period of validity |
