基于HPLC多指标成分定量控制和化学计量学的孕康颗粒综合评价  

Comprehensive Evaluation of Yunkang Granules Based on HPLC Multi-index Quantitative Control and Chemometrics

作　　者：汪小彩 王晓波 褚书豪 WANG Xiaocai;WANG Xiaobo;CHU Shuhao(Department of Pharmacy,The Third Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou,Henan 450008,China;School of Pharmacy,Henan University of Chinese Medicine,Zhengzhou,Henan 450046,China)

机构地区：[1]河南中医药大学第三附属医院药学部,河南郑州450008 [2]河南中医药大学药学院,河南郑州450046

出　　处：《今日药学》2025年第1期37-43,共7页Pharmacy Today

基　　金：河南省高等学校重点科研指导计划项目(20B550007)。

摘　　要：目的建立HPLC多指标成分定量控制和化学计量学的孕康颗粒综合评价方法。方法采用HPLC法,样品的50%甲醇提取液采用Nucleosil C18色谱柱;流动相:乙腈(A)-0.2%磷酸水溶液(B);检测波长:254 nm检测毛蕊异黄酮葡萄糖苷、芒柄花苷和9,10-二甲氧基紫檀烷-3-O-β-D-葡萄糖苷,280 nm检测黄芩苷和汉黄芩苷,235 nm检测京尼平苷酸、京尼平苷和松脂醇二葡萄糖苷;采用SPSS 26.0统计软件对孕康颗粒中8个成分含量进行聚类分析。结果8种成分分别在1.09~27.25、0.66~16.50、0.87~21.75、22.59~564.75、5.37~134.25、1.53~38.25、2.27~56.75、2.69~67.25μg·mL-1(r≥0.9991)范围内线性关系良好;平均加样回收率分别为98.09%、96.79%、98.35%、100.02%、99.27%、97.66%、98.68%和99.07%,RSD分别为1.16%、1.19%、1.47%、0.67%、0.89%、1.54%、1.26%和1.42%;化学计量学表明14批样品分为3类,筛选出孕康颗粒的差异性成分为毛蕊异黄酮葡萄糖苷、黄芩苷、汉黄芩苷、京尼平苷和松脂醇二葡萄糖苷。结论建立的多指标成分定量控制和化学计量学方法可用于孕康颗粒多指标质量评价。OBJECTIVE To establish a comprehensive evaluation method for Yunkang granules based on HPLC multi component quantitative control and chemometrics.METHODS HPLC analysis was performed using a Nucleosil C18 column with a 50%methanol extract of the sample,and the mobile phase was a mixture of acetonitrile(mobile phase A)and water containing 0.2%phosphoric acid solution(mobile phase B).The detection wavelengths were set at 254 nm for calycosin 7-O-β-D-glucopyranoside,ononin,and 9,10-dimethoxy-pterocarpane-3-O-β-D-glucoside;280 nm for baicalin and wogonoside;235 nm for geniposidic acid,geniposide,and pinoresinol diglucoside.The cluster analysis was conducted for the content results of eight constituents in Yunkang granules by SPSS 26.0 statistical software.RESULTS Eight components showed good linear relationships within the ranges of 1.09-27.25,0.66-16.50,0.87-21.75,22.59-564.75,5.37-134.25,1.53-38.25,2.27-56.75,2.69-67.25μg·mL-1(r≥0.9991),with average recoveries of 98.09%,96.79%,98.35%,100.02%,99.27%,97.66%,98.68%,and 99.07%,and RSDs of 1.16%,1.19%,1.47%,0.67%,0.89%,1.54%,1.26%,and 1.42%,respectively.The chemometrics showed that the 14 batches were divided into three categories.The differential components of Yunkang granules,identified through chemometrics,were calycosin 7-O-β-D-glucopyranoside,baicalin,wogonoside,geniposide,and pinoresinol diglucoside.CONCLUSION chemometrics can be used for the multi-index quality evaluation of Yunkang granules.

关 键 词：孕康颗粒 毛蕊异黄酮葡萄糖苷 黄芩苷 汉黄芩苷 京尼平苷 松脂醇二葡萄糖苷 定量控制 化学计量学 

分 类 号：R917[医药卫生—药物分析学]