基于药物体系质量评价模式的蒲黄质量表征关联分析研究

Quality representation and correlation analysis of Puhuang based on quality evaluation model of drug system

目的建立基于药物体系的蒲黄饮片质量表征及关联分析方法,全面评价蒲黄饮片质量。方法采用HPLC同时测定16批蒲黄饮片中香蒲新苷、异鼠李素-3-O-新橙皮苷、异鼠李素、β-谷甾醇、豆甾醇等5种主要有效指标性成分及其和的含量。采用三氯化铁-铁氰化钾显色法测定蒲黄中以黄酮类为主的酚类含量,香草醛-高氯酸显色法测定蒲黄总甾醇含量,并使用非关联系数δ、非关联度、关联度等相关概念表征各批号蒲黄饮片与基准饮片质量关联性。结果批号7、3、5、4、10、13有效指标性成分总体含量高于基准批号8,批号5、7、6、10、1、13与基准批号8关联性最高,综合评价得出批号7、5、10、13优良度居前。结论基于药物体系质量评价模式,通过将有效指标性成分含量、组成大类总含量及其相对比值与具有确切药效的基准饮片的关联度结合分析,可综合精准评价蒲黄饮片质量优次,为蒲黄饮片筛选、药物原料质量控制及应用提供了依据,同时为中药质量评价提供了方法学及其应用借鉴。

Objective To establish quality representation and correlation analysis method of Puhuang（ Pollen Typhae Angustifoliae） pieces based on drug system and evaluate Puhuang quality comprehensively. Methods HPLC was used for simultaneous determination of five major active ingredients and their total amount in 16 batches of Puhuang（ Pollen Typhae Angustifoliae.） decocting pieces,including typhaneoside,isorhamnetin-3-O-neohesperidoside,isorhamnetin,stigmasterol,and β-sitosterol. Ferric chloride-potassium ferricyanide colorimetric method was used for measuring the content of phenols in flavonoids while vanillin-perchloric acid colorimetric method was used for the determination of pollen by measuring the total sterol content of pollen Typhae. Non-correlation coefficient, noncorrelation degree,and correlation degree were used to represent quality correlation between samples and reference products. Results Levels of active ingredients were higher in No. 7,3,5,4,10 and 13 Puhuang pieces than No. 8（ reference product）. No. 5,7,6,10,1,and 13 batches had high relevance with the reference product No. 8. Consolidated quality characterization and correlation analysis showed that the quality of No. 7,5,10,and 13 were superior. Conclusion Based on drug quality evaluation system,measurement of active ingredient levels,total amount and relative ratio combined with correlation analysis of reference product with definite efficacy could offer a comprehensive assessment of quality of Puhuang decocting pieces. This method could provide evidence for screening, quality control and application of Puhuang decocting pieces. It also serves as references for quality evaluation of Chinese materia medica both in methodology and application.