利用质量控制和方法确认数据评定肉苁蓉药材中指标含量测量不确定度

Evaluation of Uncertainty of Measuring Echinacoside,Mullein Glycosides Content in Cistanche by Quality Control and Method Validation Data

目的:对肉苁蓉药材中松果菊苷、毛蕊花糖苷含量进行测量不确定度评定。方法:参考《化学检测领域测量不确定度评定利用质量控制和方法确认数据评定不确定度(RB/T 141-2018)》,通过安达森-达林检验验证测量系统,应用期间精密度及方法确认数据,计算出期间精密度不确定度分量uR′、偏倚不确定度分量ub、合成标准不确定度uc与扩展不确定度U。结果:经过安德森-达林检验,证明测量系统符合正态性与独立性假设,质量控制数据与期间精密度数据可用于不确定度计算。结论:期间精密度和方法确认数据可用于检验实验室对肉苁蓉药材中松果菊苷、毛蕊花糖苷含量的测量不确定度评定,此评定方法也可用于其他药材的含量测量不确定评定。

Objective:To evaluate the uncertainty of measuring echinacoside,mullein glycosides content in cistanche.Methods:According to“Evaluation of Measurement Uncertainty in Field of Chemical Detection Evaluating Uncertainty Using Quality Control and Method Validation Data(RB/T 141-2018)”,the assumption of measurement system normality and independence was examined by Anderson-Darling test,with the quality control results and method validation date,the uR′of intermediate precision uncertainty and the ubof bias uncertainty,synthetic standard uncertainty ucand expanded uncertainty U was calculated.Results:Anderson-Darling test proves that the measurement system conforms to the assumption of normality and independence,and the quality control and method validation data can be used for evaluating the measurement uncertainty.Conclusion:The quality control results and method validation date can be used for evaluating the measurement uncertainty of Echinacoside、Mullein glycosides content in Cistanche in detection laboratories,it can also be used to evaluate Measurement Uncertainty for other medicinal materials.