基于多源数据融合技术的盐酸青藤碱制备工艺一致性评价方法研究

A Study on Consistency Evaluation of Preparation of Sinomenine Hydrochloride Based on Multi-source Data Fusion Technique

为考察使用不同提取溶剂制得的盐酸青藤碱的质量差异,探究青藤碱提取工艺变更的可行性,该文运用近红外光谱技术、拉曼光谱技术结合多源数据融合技术,对苯提取和酸水渗漉-氯仿萃取后所制的盐酸青藤碱样品的质量进行系统评价,比较了两种溶剂对产品质量的潜在影响。在低、中、高水平3种融合模式下,分别利用相似度匹配值(SMV)、Hotelling T^(2)和DModX 3种统计量对样品整体质量进行表征。结果表明:在低水平融合模式下,有9份样品的DModX值超出了控制限;在中水平融合模式下,有1份样品的SMV低于控制限;在高水平融合模式下,有3份样品的SMV在控制限以下,有5份样品的DModX值在控制限以上。与利用酸水渗漉-氯仿萃取法制得的样品(从A公司获得)相比,除个别样品需要仲裁分析进行质量确认外,苯提取后制得的样品(从B公司获得)和酸水渗漉-氯仿萃取后制备的样品(从C公司获得)质量一致性良好,在青藤碱提取工艺过程中可以利用低毒性的氯仿替代对人体危害较大的苯。

To investigate the quality difference of sinomenine hydrochloride prepared with different extraction solvents and explore the feasibility of changing the extraction process,the quality of sinomenine hydrochloride samples prepared by benzene and acid water percolation-chloroform extraction were systematically evaluated using near-infrared spectroscopy,Raman spectroscopy combined with multi-source data fusion technique.Subsequently,the potential effects of the two solvents on product were compared.The overall quality of the samples were characterized with the different statistics named similarity matching value(SMV),Hotelling T^(2) and DModX,under three fusion modes of low,medium and high levels.Under the low level fusion mode,the results showed that the DModX values of nine samples exceeded the control limit.Under the medium level fusion mode,the SMV of one sample was lower than the control limit.Under the high level fusion mode,the SMVs of three samples were below the control limit,and the DModX values of five samples were above the control limit.Compared with the samples obtained by acid water percolation-chloroform extraction(obtained from manufacturer A),the quality consistency of the samples prepared by benzene(obtained from manufacturer B)and chloroform extraction(obtained from manufacturer C)is good,except that several samples need arbitration analysis for quality confirmation.In the process of sinome⁃nine extraction,chloroform with low toxicity could be used to replace benzene which is harmful to human health.The study is aimed to develop a new strategy for evaluating the quality difference of traditional Chinese medicine products before and after the change of preparation process.