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目的：分析生物合成胰岛素注射液启封后有效期内细菌污染情况，并总结其合理的使用方法及时间。方法：收集我院各个科室使用的胰岛素注射液96 瓶，启封后分别在不同使用时间和保存温度下采集样本进行细菌学检测。结果：本实验中96瓶启封后有效期内的生物胰岛素注射液中，共有10 瓶细菌培养呈阳性，阳性率为10.41%。其中7d 之内启封的胰岛素注射液细菌培养全部呈阴性，其余各组的胰岛素注射液细菌培养均呈阳性及存在菌落，随着启封时间的延长，细菌培养阳性率及菌落数上升，且各组之间的差异均具有统计学意义（P<0.05）。研究中保存温度2~4℃的细菌培养全部呈阴性，其余各组的胰岛素注射液细菌培养均呈阳性及存在菌落，随着保存温度的升高，细菌培养阳性率及菌落数上升，且各组之间的差异均具有统计学意义（P<0.05）。结论：胰岛素注射液启封后有效期内随着时间的延长以及保存温度的升高，细菌培养的阳性率及菌落数量上升，临床使用时要应尽量在 7d 内使用完，并且尽量保存在低于25℃环境中。

英文摘要:

Objective:To analyze the bacterial contamination situation of unsealed biosynthesis insulin injection in validity period, and summarize its reasonable use method and time.Methods:A total of 96 unsealed bottles of biosynthesis insulin injection from various departments were collected and detected the bacterial situation in different time and preservation temperature in validity period.Results:Among the 96 unsealed bottles of biosynthesis insulin injections, there were 10 bottles of positive, the bacterial positive rate was 10.41%. The other injection groups were positive and existed colony except that the unsealed biosynthesis insulin injections within 7 days were negative; the longer injections unsealed, the more bacterial positive rate and colony amount, the difference among these groups was statistically significant (P<0.05). The biosynthesis insulin injections preserved in 2~4℃ were negative, but the other injections groups in other different preservation temperature were positive and existed colony, the higher preservation temperature, the more bacterial positive rate and colony amount, the difference among these groups was statistically significant (P<0.05).Conclusion:With the lengthening of unsealing time and rising of preservation temperature, the bacterial positive rate and colony amount of unsealed biosynthesis insulin injection in validity period are increasing,so the biosynthesis insulin injection needs to be used up within 7 days after unsealing,and it is better to be preserved under 25℃.

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