垂体后叶注射液中升压素效价测定的不确定度评定  

Evaluation of Uncertainty in the Titer Determination of Vasopressin in Posthypophysis Injection

作　　者：谢鹏 宁玲 田婧 张赞 吴超权 黄宪 林昊 

机构地区：[1]广西壮族自治区食品药品检验所,广西南宁530012

出　　处：《大众科技》2022年第8期94-97,共4页Popular Science & Technology

摘　　要：目的:建立垂体后叶注射液中升压素效价测定的不确定度评定的方法。方法:建立评定垂体后叶注射液中升压素效价测定的模型,分析其测定不确定度的影响因素,并对各分量进行量化分析,计算扩展不确定度。结果:垂体后叶注射液中升压素效价的影响值排序为:微量注射器药液注射过程>供试品溶液的配制>标准品溶液的配制>血压反应的测定过程>环境温度>标准品的纯度。垂体后叶注射液中升压素效价的扩展不确定度为0.2414 IU/mL,其效价可表示为(5.7822±0.2414)IU/mL,为标示量的(96.37±4.02)%。结论:该方法适用于垂体后叶注射液中升压素效价测定的不确定度评定,为优化实验过程,提高实验结果的可靠性提供参考。Objective: To establish a method of the uncertainty evaluation of the potency of vasopressin in posthypophysis injection.Method: Model for potency of vasopressin in posthypophysis injection was established to analyze the influential factors of uncertainty. The uncertainty components were quantitatively analyzed and the expanded uncertainty was calculated. Results: The order of the influence value of vasopressin titer in posthypophysis injection was as follows: process of microsyringe injection> preparation of test solution>preparation of standard solution> determination of blood pressure> ambient temperature> the purity of standard. The expanded uncertainty of the potency of vasopressin in posthypophysis injection was 0.2414 IU/ml and the potency of was(5.7822±0.2414) IU/mL, equivalent to(96.37±4.02)% of the labeled amount. Conclusion: This method can be used to evaluate the uncertainty evaluation of the potency of vasopressin in posthypophysis injection, which provides reference for optimizing the experiment and improving the reliability of the results.

关 键 词：垂体后叶注射液 升压素 效价 不确定度 

分 类 号：R97[医药卫生—药品]