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

WU Si-jun; WANG Long; WU Hong-gen; HE Xing-li; QIU Ping; LI Zheng; LI Wen-long

doi:10.19969/j.fxcsxb.21093007

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

Scientific Papers | 更新时间：2023-01-04

- A Study on Consistency Evaluation of Preparation of Sinomenine Hydrochloride Based on Multi-source Data Fusion Technique
- Journal of Instrumental Analysis Vol. 41, Issue 1, Pages: 121-127(2022)
- 作者机构：
  
  1.天津中医药大学中药制药工程学院，天津 301617
  2.天津中医药大学省部共建组分中药国家重点实验室，天津 301617
  3.湖南正清制药集团股份有限公司，湖南怀化 418000
- 作者简介：
- 基金信息：
- DOI：10.19969/j.fxcsxb.21093007
  CLC：
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吴思俊,王龙,吴红根等.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[J].分析测试学报,2022,41(01):121-127.

WU Si-jun,WANG Long,WU Hong-gen,et al.A Study on Consistency Evaluation of Preparation of Sinomenine Hydrochloride Based on Multi-source Data Fusion Technique[J].Journal of Instrumental Analysis,2022,41(01):121-127.
吴思俊,王龙,吴红根等.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[J].分析测试学报,2022,41(01):121-127. DOI： 10.19969/j.fxcsxb.21093007.

WU Si-jun,WANG Long,WU Hong-gen,et al.A Study on Consistency Evaluation of Preparation of Sinomenine Hydrochloride Based on Multi-source Data Fusion Technique[J].Journal of Instrumental Analysis,2022,41(01):121-127. DOI： 10.19969/j.fxcsxb.21093007.

摘要

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。

Abstract

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 sinomenine 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．

关键词

盐酸青藤碱多源数据融合技术近红外光谱技术拉曼光谱技术工艺变更

Keywords

sinomenine hydrochloridemulti-source data fusion techniquenear-infrared spectroscopyRaman spectroscopyprocess change

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School of Medicine， Hunan Normal University

College of Food Science and Technology， Hunan Provincial Key Laboratory of Food Science and Biotechnology， Hunan Agricultural University

Hunan Agricultural Product Processing Institute，Hunan Academy of Agricultural Sciences

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