HPLC同时测定茵胆平肝胶囊4种成分含量的不确定度评定

Evaluation of Uncertainty for Content Determination in Yindan Pinggan Capsule by HPLC

目的:建立HPLC法同时测定茵胆平肝胶囊中龙胆苦苷、栀子苷、芍药苷和黄芩苷含量不确定度评定分析方法,探讨合成标准中影响含量测定不确定度贡献较大的分量。方法:建立含量测定数学模型,分析含量测定的不确定度来源,进行扩展不确定度的评定。结果:含量测定不确定度的主要影响因素由体积类分量引入,茵胆平肝胶囊中龙胆苦苷、栀子苷、芍药苷、黄芩苷的高效液相色谱法含量测定报告结果(k=2)分别为(17.66±0.28),(7.62±0.12),(2.05±0.04),(4.88±0.08)mg/g。结论:建立的含量测定不确定评定使测定结果更准确可靠,检验报告更完整,对中药或制剂质量标准制定具有指导意义。

Objective:An evaluation and analysis method for the uncertainty of gentiopicroside,geniposide,paeoniflorin and baicalin in Yindan Pinggan Capsule by HPLC was established to explore the components that contributed greatly to the uncertainty of content determination in the synthetic standard.Methods:The mathematical model of content determination was established,the sources of uncertainty were analyzed,and the expanded uncertainty was evaluated.Results:The main influencing factors of uncertainty in content determination are introduced by volume component.The uncertainty of gentiopicroside,geniposide,paeoniflorin and baicalin in Yindan Pinggan Capsule by HPLC was(17.66±0.28),(7.62±0.12),(2.05±0.04),(4.88±0.08)mg/g(k=2).Conclusion:The established uncertainty evaluation of content determination makes the determination more complete,more accurate and reliable,and has guiding significance for the formulation of quality standards of traditional Chinese medicine or preparations.