银黄颗粒中药材-中间体-成方制剂抑菌谱-效相关质量评价系统的建立  

Establishment of spectrum-antibacterial effect correlation quality evaluation system of Yinhuang Granules and its raw medicinal materials, extracts and preparation

作　　者：高燕[1] 马山[1] 杨龙飞[1] 吕婧[1] 俎龙辉 王变利[2] 谢强胜 赵渤年 GAO Yan;MA Shan;YANG Long-fei;LV Jing;ZU Long-hui;WANG Bian-li;XIE Qiang-sheng;ZHAO Bo-nian(Shandong University of Traditional Chinese Medicine,Jinan 250355,China;Shandong Academy of Chinese Medicine,Jinan 250014,China;Shandong Institute for Food and Drug Control,Jinan 250101,China)

机构地区：[1]山东中医药大学,山东济南250355 [2]山东省中医药研究院,山东济南250014 [3]山东省食品药品检验研究院,山东济南250101

出　　处：《中草药》2020年第17期4449-4456,共8页Chinese Traditional and Herbal Drugs

基　　金：国家重点研发计划项目(2017YFC1701501);国家重点研发计划项目(2017YFC1702700);山东省重点研发计划(2016GSF202005);山东省重点研发计划(2017CXGC1306)。

摘　　要：目的构建银黄颗粒中药材-中间体-成方制剂抑菌谱-效相关质量评价系统。方法首先采用最小二乘支持向量机(LS-SVM)方法,建立银黄颗粒体外抑菌谱-效相关质量评价系统;再采用有监督的偏最小二乘判别分析(PLS-DA)方法,对黄芩药材、金银花药材、黄芩提取物、金银花提取物、银黄颗粒谱-效相关抑菌药效评价结果进行评判。结果建立的银黄颗粒体外抑菌谱-效相关质量评价数学模型,预测结果平均相对误差在5%以下;黄芩药材、黄芩提取物、金银花药材、金银花提取物的抑菌率分别大于43%、5.5%、11%、37%,可以保证银黄颗粒87%的样品抑菌率大于11%(优质样品)。结论建立的银黄颗粒中药材-中间体-成方制剂抑菌谱-效相关质量评价系统,能够实现中成药生产投料关键环节的质量控制,评价结果更科学、全面、准确。Objective To establish the quality evaluation system based on spectrum-antibacterial effect correlation of Yinhuang Granules in order to detect its raw medicinal materials, extracts, and preparation simultaneously. Methods Firstly, the spectrumantibacterial effect correlation quality evaluation system of Yinhuang Granules was established by using Least Squares Support Vector Machine(LS-SVM). Then, by using supervised partial least square-discriminant analysis models(PLS-DA), the antibacterial effect evaluation was judged based on the spectrum-antibacterial effect data of Scutellariae Radix, Lonicerae Japonicae Flos, Scutellaria extract, Lonicerae japonica extract, and Yinhuang Granules. Results The mathematical model of Yinhuang Granules based on spectrum-antibacterial effect correlation was established;The average relative error of the prediction results was less than 5%, and the antibacterial rate of Scutellariae Radix, Scutellaria Radix extract, Lonicerae Japonicae Flos, Lonicerae japonica extract was greater than 43%, 5.5%, 11%, 37% calculated by their mathematical model, which can ensure the antibacterial effect was greater than 11%(correct rate was 87%). Conclusion The quality evaluation system can realize the quality control of the key link of the production of traditional Chinese medicine, the evaluation results are more scientific, comprehensive, and accurate.

关 键 词：银黄颗粒 谱-效相关 抑菌 质量评价 最小二乘支持向量机 偏最小二乘判别分析 黄芩 金银花 质量控制 

分 类 号：R285.5[医药卫生—中药学]