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缩宫素注射液效价测定的不确定度评定

     

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 un-certainty. The uncertainty components were quantitatively analyzed and the uncertainty was calculated. RESULTS:The expanded un-certainty 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.

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