A Study on Consistency Evaluation of Preparation of Sinomenine Hydrochloride Based on Multi-source Data Fusion Technique
  
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KeyWord:sinomenine hydrochloride  multi-source data fusion technique  near-infrared spectroscopy  Raman spectroscopy  process change
  
AuthorInstitution
WU Si-jun,WANG Long,WU Hong-gen,HE Xing-li,QIU Ping,LI Zhen,LI Wen-long 1. College of Pharmaceutical Engineering of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin ,China; 2. State Key Laboratory of Component-based Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin ,China; 3. Hunan Zhengqing Pharmaceutical Group Co.,Ltd.,Huaihua ,China
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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 T2 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.
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