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

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。

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

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 spectrum-antibacterial 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.