室温保存时间对万邦中性胰岛素笔芯生物效价的影响  

Effects on the biological potency of Wanbang Neutral Insulin Vial by time of exposure at room temperature

作　　者：王涛[1] 陈雪辉[1] 曹萌[1] 尹清风[1] 李燕[1] 王业民[1] 

机构地区：[1]新乡医学院第一附属医院,河南新乡453100

出　　处：《中国医药导报》2011年第15期50-51,54,共3页China Medical Herald

摘　　要：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。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.

关 键 词：胰岛素 生物效价 生物检定 温度 

分 类 号：R977.15[医药卫生—药品]