基于药物体系质量评价模式的柴胡质量表征关联分析研究

目的：运用药物体系质量评价模式对柴胡饮片进行质量表征及关联分析，以有效地评价柴胡饮片的质量。方法：采用HPLC法同时测定柴胡饮片中药物体系关联成分芦丁、柴胡皂苷c、柴胡皂苷a、柴胡皂苷d的含量，同时表征主要黄酮类成分含量和及主要皂苷类成分含量和，并采用可见分光光度法测定柴胡饮片中总酚类成分含量。结果：基于药物体系质量评价模式，对柴胡饮片中有效指标性成分含量及其相对比值进行质量表征，同时将不同批次的饮片与经过药效验证的基准饮片进行关联度分析。结果表明，样品7、8、14中有效指标性成分含量总体高于基准批号5，批号6中有效指标性成分含量与基准批次饮片5相近，样品7、8、13、14与基准批次饮片5关联度较高。综合质量表征及关联分析结果，样品7、8、14、5、13的品质居优。结论：基于药物体系质量评价模式对柴胡饮片的质量进行评价，通过有效指标性成分含量及其相对比值的质量表征，以经过药效验证的饮片为基准，结合关联度分析，可综合全面地评价柴胡饮片的质量，为柴胡饮片的资源筛选、药物原料的质量控制和应用提供依据，同时为中药质量评价提供了方法学及其应用借鉴。

Quality Representation and Correlation Analysis of Chaihu (Bupleuri Radix) Based on the Quality Evaluation Model of Drug System

To establish quality representation and correlation analysis on Chaihu (Bupleuri Radix) based on the quality evaluation model of drug system.Methods:Use HPLC method to simultaneously determine the 4 effective index components of Chaihu, including rutin, saikosaponin c, a, and d, meanwhile characterize the main contents of flavonoids and saponins. Use visible spectrophotometry to determine the content of total phenolic in Chaihu.Results:Based on the quality evaluation model of drug system to characterize and correlation analysis the effective indicator ingredients and the relative ratio of them. Then evaluate the associate degree of pieces of different batches and the reference piece. The result shows the total content of effective index components in No. 7, No. 8, No. 14 is higher than No. 5 and No. 6 is closer to No. 5. No. 7, No. 8, No. 13 No. 14 have high associate degree with No.5.Comprehensive quality characterization and correlation analysis results, the No.7, No.8, No.14, No.5, No.13 have high quality ranking.Conclusion:Quality representation and correlation analysis of Chaihu are based on a new quality evaluation model of drug system. Considering quality representation based on the content and the content relative ratio of effective index components comprehensively. This paper reports the specific applications of a new way of thinking model for the quality representation and evaluation of Chaihu, providing the foundation of raw material quality control and application screening.