五味子饮片标准汤剂质量评价研究

Study on Quality Evaluation of Standard Decoction of Schisandrae Chinensis Fructus

关键词:  五味子  标准汤剂  质量评价  指纹图谱  聚类分析

Key words:  Schisandrae Chinensis Fructus  standard decoction  quality evaluation  fingerprint  cluster analysis

摘要:

目的 制备五味子饮片标准汤剂，并进行质量评价。方法 采用传统水煎煮方法，选择具代表性的20批次五味子饮片制备汤剂，对pH值、出膏率、指标成分含量、转移率及HPLC指纹图谱相似度等进行考察，并对标准汤剂HPLC指纹图谱进行相似度评价和聚类分析，探讨五味子煎煮过程中的质量传递规律。结果 20批五味子饮片标准汤剂的pH值为2.98~3.73，出膏率为16.89%~24.52%，平均出膏率为21.96%，标准偏差为8.16%；五味子醇甲的转移率为74.94%~96.29%，平均转移率为89.12%，标准偏差为8.27%；五味子醇乙的转移率为72.61%~97.63%，平均转移率为90.42%，标准偏差为7.79%。指纹图谱确定了12个共有峰，其相似度>0.9。聚类分析将4个产地的五味子饮片标准汤剂归为2类，不同产地的五味子饮片存在质量差异。结论 本研究为五味子饮片标准汤剂质量控制建立了一套具有科学性和实用性的分析方法，也为其制剂质量评价方法的建立提供了参考。

Abstract:

OBJECTIVE To prepare standard decoctions and establish the methods for quality control of standard decoction. METHODS Using traditional water decocting method, 20 batches of standard decoction of Schisandrae Chinensis Fructus were prepared, parameters such as pH value, indicative component content, transfer rate and similarity of HPLC fingerprint, were selected as the indexes for quality evaluation. Similarity evaluation and cluster analysis were performed for HPLC fingerprint of standard decoction, to study the law of mass transfer in standard decoction of Schisandrae Chinensis Fructus. RESULTS Through the determination of 20 batches of Schisandrae Chinensis Fructus sample and standard decoctions, the pH values of the 20 batches of standard decoctions of Schisandrae Chinensis Fructus was 2.98-3.73, the paste-out rate was 16.89%-24.52%, and the average paste-out rate was 21.96%, the standard deviation was 8.16%, the transfer rate of schisandrol A was 74.94%-96.29%, the average metastasis rate was 89.12%, the standard deviation was 8.27%; the transfer rate of schisandrol B was 72.61%-97.63%, the average transfer rate was 90.42%, the standard deviation was 7.79%. Twelve principal common peaks were identified by fingerprinting analysis, the similarity was greater than 0.9. In cluster analysis, the standard decoctions of Schisandrae Chinensis Fructus from 4 producing areas were classified into 2 categories, indicating that there were quality differences among different producing areas of Schisandrae Chinensis Fructus pieces. CONCLUSION The research provide a scientific and practical method for quality control of standard decoction of Schisandrae Chinensis Fructus, and also provide reference for quality evaluation of the preparations.