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目的:评价黄金菊药效组分标准物质[1]分量定值的不确定度。方法:建立数学模型,逐层对三批(批号为20110201、20110202、20110203)黄金菊药效组分标准物质分量定值的不确定度来源进行分步计算和整体合成,得到合成标准不确定度(Uc)和扩展不确定度(U)。结果:黄金菊药效组分中黄芩苷的含量测定结果20110201:(88.04±0.84)%,20110202:(88.03±0.84)%,20110203:(88.06±0.84)%;绿原酸的含量测定结果20110201:(5.67±0.12)%,20110202:(5.67±0.16)%,20110203:(5.67±0.12)%;荭草苷的含量测定结果20110201:(4.53±0.09)%,20110202:(4.54±0.09)%,20110203:(4.54±0.09)%;牡荆苷的含量测定结果20110201:(1.136±0.02)%,20110202:(1.135±0.02)%,20110203:(1.134±0.02)%,k=2,p=95%。结论:影响药效组分标准物质分量定值的不确定度的主要是操作因子中的称量、定容和移液。
OBJECTIVE: To evaluate the uncertainty of the quantitative value of the reference substance [1] of ruminal medicinal components. Methods: The mathematic model was set up. The uncertainty sources of the three components (20110201, 20110202, 20110203) of the standard components of Ruddy tomentosa were identified by stepwise calculation and overall synthesis. The results showed that the synthetic standard uncertainty (Uc) and extended uncertainty (U). Results: The results showed that the content of baicalin in the components of rubeprotes was 20110201: (88.04 ± 0.84)%, 20110202: (88.03 ± 0.84)%, 20110203: (88.06 ± 0.84)%; the content of chlorogenic acid was 2012011 : (5.67 ± 0.12)%, 20110202: (5.67 ± 0.16)%, 20110203: (5.67 ± 0.12)%; , 20110203: (4.54 ± 0.09)%; Vitexin content determination results 20110201: (1.136 ± 0.02)%, 20110202: (1.135 ± 0.02)%, 20110203: (1.134 ± 0.02)%, k = 2, p = 95%. CONCLUSION: The main determinants of the uncertainty of the standard components of the efficacy components are weighing, constant volume and pipetting in the operating factors.