国产胰岛素注射液开启后有效保存时限的研究

目的确定国产胰岛素注射液开启后有效保存时限，为临床安全使用提供依据。方法供试品开启后，采用《中国药典》2005版无菌检查法做细菌、真菌检查。采用HPLC法测定供试品开启当天和微生物学有效保存时限末天的色谱峰面积，将两者的峰面积做配对比较，确定胰岛素的含量有无改变。结果供试品在开启28d后，经无菌检查，无一检出细菌、真菌。22份供试品在开启当天和开启后第28d所做的高效液相色谱得到的峰面积，差异无统计学意义（t=0．212，P=0．834）。结论胰岛素开启后，在28d内，临床使用是安全的。

The Research of the Effective Preservation-time Limit of the Open Insulin Injection Made in China

Objective It would provide the base of safe using at the clinics, to make sure the effective preservation-time limit of the open insulin injection made in China（ insulin injection）. Methods We adopt the method of sterility test of the Pharmacopoeia of China with 2005 edition to do the check of bacteria and fungus after the samples being opened. In order to determining if the content of the insulin injection change, we determine the chromatography-peak areas by the high potency liquid chromatography at the first day after the samples being opened and the end day of the effective preservation-time limit in microbiology determined, and make paired comparison with the peak areas of both sides. Results After examined samples are opened, they are done by sterility test in 28 days, and no bacteria or fungus are fond in them. The both sides peak areas are not different in statistical significance （t =0. 212,P =0. 834） that are determined by the high potency liquid chromatography at the fist day and the twenty-eighth day after the 22 examined samples being opened. Conclusion After the insulin injection is opened, it is safe to use the insulin iniection at the clinics in twenty-eight days.