山银柴胡质量标准研究

Study on Quality Standard of Gypsophilae Radix

目的:研究山银柴胡质量评价标准,建立指纹图谱分析方法。方法:参照2020年版中国药典的方法测定山银柴胡水分、总灰分、酸不溶性灰分、醇溶性浸出物含量;采用HPLC法测定山银柴胡中成分含量;建立30批山银柴胡的指纹图谱,结合相似度评价、聚类分析、正交偏最小二乘判别分析(OPLS-DA)进行质量评价。结果:30批山银柴胡的水分、总灰分、酸不溶性灰分、醇溶性浸出物、丝石竹皂苷元3-O-β-D-葡萄糖醛酸甲酯、丝石竹皂苷元、皂皮酸含量的平均值分别为8.89%、12.67%、0.79%、34.53%、13.58 mg/g、1.62 mg/g、1.03 mg/g;指纹图谱确定了17个共有峰,样品与对照图谱的相似度为0.916~0.997,聚类分析可将样品分为3类,OPLS-DA分析筛选出7个质量差异性成分。结论:该研究建立的方法可为山银柴胡质量标准的完善提供参考。

Objective:To study the quality evaluation standard of Gypsophilae Radix,to establish the fingerprint analysis method.Methods:Water content,total ash content,acid insoluble ash content and ethanol soluble extract content of Gypsophilae Radix were determined according to the relevant methods in the appendix of Chinese Pharmacopoeia(2020 edition).HPLC method was used to determine the content of index components in Gypsophilae Radix.The fingerprint of 30 batches of Gypsophilae Radix was established,and the quality was evaluated by similarity evaluation,cluster analysis,orthogonal partial least squares discriminant analysis(OPLS-DA).Results:The mean values of water,total ash,acid insoluble ash,ethanol soluble extract,methyl gypsogenin 3-O-β-D-glucuronopyranoside,gypsogenin and quillaic acid were 8.89%,12.67%,0.79%,34.53%,13.58 mg/g,1.62 mg/g,1.03 mg/g,respectively.A total of 17 common peaks were found in 30 batches of Gypsophilae Radix fingerprint.The similarity of 30 batches of samples ranged from 0.916 to 0.997.The samples were divided into three categories by cluster analysis,and seven different components were screened out by OPLSDA analysis.Conclusion:The method established in this study can provide reference for the establishment of quality standard of Gypsophilae Radix.