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。 OBJECTIVE: To analyze the bacterial contamination during the validation period of biosynthetic insulin injection after unsealing, and to summarize its reasonable usage and time. Methods: Ninety-six bottles of insulin injection used in various departments of our hospital were collected. After unsealing, specimens were collected for bacteriological examination at different usage times and storage temperatures respectively. Results: In this experiment, 96 bottles of bioinsulin injection within the validity period after unsealing, a total of 10 bottles of bacteria culture positive, the positive rate was 10.41%. Among them, the bacterial cultures of insulin injections within 7 days were all negative, while the other groups were all positive for bacterial culture and colonies. With the extension of unsealing time, the positive rate of bacterial culture and the number of colonies increased, The differences were statistically significant (P <0.05). In the study, bacterial cultures at 2 ~ 4 ℃ were all negative, and all other groups were positive for bacterial culture and colonies. With the increase of storage temperature, the positive rate of bacterial culture and the number of colonies increased Differences between the groups were statistically significant (P <0.05). CONCLUSION: The positive rate of bacterial culture and the number of colonies increased with the prolongation of storage time and the storage temperature during the effective period of unsealed insulin injection, and should be used within 7 days as much as possible during clinical use and should be kept at less than 25 ℃ environment.