摘要
目的:建立缩宫素注射液效价测定的不确定度评定方法。方法:建立评定缩宫素注射液效价测定的不确定度的数学模型,分析其测定不确定度的影响因素,并将由之引起的不确定度分量进行量化分析,计算扩展不确定度。结果:缩宫素注射液效价测定的扩展不确定度为0.20 u/ml,其效价可表示为(9.29±0.20)u/ml,包含因子K=2。结论:该方法适用于缩宫素注射液效价测定的不确定度评定。
OBJECTIVE：To establish a method of the uncertainty evaluation of the potency testing of Oxytocin injection.METHODS：Mathematical model was established for potency testing of Oxytocin injection to analyze the influential factors of uncertainty. The uncertainty components were quantitatively analyzed and the uncertainty was calculated. RESULTS：The expanded uncertainty of the potency testing of Oxytocin injection was 0.20 u/ml and the potency was（9.29±0.20）u/ml,coverage factor K=2.CONCLUSIONS：The method is suitable for the uncertainty evaluation of potency testing of Oxytocin injection.
出处
《中国药房》
CAS
北大核心
2015年第18期2575-2578,共4页
China Pharmacy
关键词
缩宫素注射液
效价
测定
不确定度评定
Oxytocin injection Potency Testing Uncertainty evaluation
作者简介
副主任药师。研究方向：药品检验、药理毒理。电话：0991-2816492。E-mail：mfhr@163．com
