室温保存时间对万邦中性胰岛素笔芯生物效价的影响

摘要

Objective: To study the effects on the biological potency of Wanbang Neutral Insulin Vial by time of exposure to room temperature.Methods: Crossover designed bioequivalence test was performed.Wanbang Neutral Insulin Vial, which was normally stored at 2-4℃, was used as the control group.The biological potency of Wanbang Neutral Insulin Vial which was stored at 25℃for 3 weeks, 4 weeks, and 5 weeks was tested respectively.Results: After being stored at 25℃ for 3 weeks, 4 weeks, 5 weeks, the biological potency confidence limits of Wanbang Neutral Insulin Vial were 91 -115 IU/ml, 89-117 IU /ml, 80-106 IU/ml.The last group was beyond the requirement in a range of 91％-116％ according to Pharmacopoeia of People's Republic of China.Conclusion: If Wanbang Neutral Insulin Vial is stored at the room temperature, and there is no effect on biological potency within 4 weeks, but no more than 4 weeks.%目的:研究室温条件下,保存时间对万邦中性胰岛素笔芯生物效价的影响.方法:以2-4℃贮藏的万邦中性胰岛素笔芯为标准品,以25℃条件下分布保存3周、4周、5周的胰岛素为供试品,采用双交叉生物检定的方法对其生物活性进行检测.结果:以在4℃保存的万邦中性胰岛素笔芯对照,25%保存3周后其效价可信限为91～115 IU/ml;4周后其效价可信限为89～117 IU/ml;5周后其效价可信限为80～106 IU/ml.25℃保存5周后其效价可信限超出了(中国药典)(2005年版)所要求的91%～116%的范围.结论:万邦中性胰岛素笔芯暴露在室温条件下4周以内对其效价无明显影响,但不宜超过4周.