基于多元数据分析研究葛根素化学对照品定值准确性与其影响因素的相关性

目的：模拟评估葛根素化学对照品定值过程中原料纯度与有机杂质对于定值的影响，为化学对照品质量平衡法定值提供有效的技术要求。方法：在化学对照品质量平衡法定值的基础上，选择葛根素化学对照品作为主成分，同时选择其结构类似物异黄酮及黄酮类化学对照品作为相关模拟的杂质，测定相应的校正因子后，定量混合，模拟制成两类考察物：一类为主成分自99.0%、98.0%…90%纯度递减的系列考察物，另一类为不同校正因子比杂质的系列考察物，两系列模拟考察物分别进行HPLC纯度测定。结果：采用析因分析方法，确定主成分纯度在99.0%~97.0%范围内，有机杂质校正因子在0.90~1.10范围内，此两项因素对定值无显著性影响，且两者间无交互效应。结论：本试验结果对于化学对照品原料的筛选及定值具有一定的指导和参考意义。

Objective: To evaluate the impact of the purity and the organic impurities of puerarin reference material during the process on the value assignment using mass balance method. Methods: Based on the value assignment method with mass balance,the reference for puerarin was used as the main component,meanwhile,the analogue isoflavone and flavonoid references were used as the impurities for related simulation.After determining the relevant corrective factors,the references were mixed quantitatively and were made into two series of preparations.One series was composed of principal components with decreasing purity from 99.0%,98.0% to 90%.Another series was used for impurities with different corrective factor ratios.Both series were examined for their purity by HPLC. Results: Through factorial analysis,the statistic results showed that the purity of principal components and the corrective factor for organic impurities had no significant effect on the HPLC determination results when the purity were in the range of 99.0%-97.0%,and the correction factors were in the range of 0.90-1.10.In addition,no cross reaction was observed. Conclusion: The experimental method can serve as a guideline and reference for the selection and assignment of reference materials.