基于药物体系的生地黄的质量评价研究

Evaluation of Quality of Dihuang( Rehmanniae glutinosa) Based on the Drug System

目的:基于药物体系的发现,并运用药物体系质量评价模式全面表征生地黄质量并关联分析,评价生地黄质量。方法:采用HPLC法首次同时测定15批生地黄饮片中梓醇、毛蕊花糖苷2种环烯醚萜苷及酚类的主要有效指标性成分的含量,首次采用香草醛-高氯酸显色法测定生地黄中总环烯醚萜含量,三氯化铁-铁氰化钾显色法测定生地黄中酚类含量,并使用非关联系数、非关联度、关联度等相关概念表征各批号生地黄饮片与基准饮片质量关联性。结果:批号2、8、14、5、4关键有效指标性成分和总环烯醚萜、总酚含量总体高于基准批号13,批号14、5关键有效指标性成分和总环烯醚萜、总酚含量与基准批号13接近。其中批号14、4、15、6、8与基准批号13关联性最高,综合评价得出批号14、5、4、8质量优良度居前,其次为批号2、15、6。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,可综合精准评价生地黄饮片质量优次,为生地黄饮片筛选、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 evaluate quality of Di Huang （ Rehmanniae glutinosa ） based on the drug system and by applying quality evaluation model of the drug system , establishing quality representation and conducting correlation analysis .Methods：The study applied HPLC method for simultaneous determination of effective iridoid glycoside （catalpol） and phenolic acids （acteoside） in 15 batches of Di Huang （ Rehmanniae glutinosa ） .The content of iridoids in Di Huang （ Rehmanniae glutinosa ） was measured by u-sing vanillin-perchloric acid colorimetric method and the total phenolic content was measured by applying ferric chloride -potassium ferricyanide colorimetric method .The relevance of each batch ’ s quality and the benchmark piece was characterized by the con-cepts of non-connection coefficient , non-relational grade , and relational grade .Results：The results showed that the total content of effective index components and overall component in No .2, No.8, No.14, No.5 , No.4 were higher than No .13, the benchmark batch , and No.14 ,No.5 were close to No.13.The correlation degree of quality representation of No .14, No.4, No.15, No.6 and No.8 were high.Consolidated quality characterization and correlation analysis , the quality of No.14, No.5, No.4 and No.8 were excellent and No.2, No.15, No.6 followed.Conclusion： Based on the quality evaluation model of the drug system, the quality of Di Huang （Rehmanniae glutinosa） can be evaluated accurately by analyzing effective index components contents and the relational grade with the benchmark patch piece which has exact efficacy .It may provide a basis for screening Di Huang （ Rehmanniae glutinosa ） piece, controlling drug material quality and the application;and also provide a methodological ref-erence for quality evaluation of traditional Chinese medicine .