Applying risk management to analytical methods for the desorbing process of ginkgo diterpene lactone meglumine injection

作     者：XU Fang-Fang BI Yu-An HUANG Wen-Zhe WANG Zhen-Zhong XIAO Wei 

作者机构：Nanjing University of Traditional Chinese Medicine Nanjing 210000 China Jiangsu Kanion Pharmaceutical Co. Ltd. Lianyungang 222000 China State Key Laboratory of New-techfor Chinese Medicine Pharmaceutical Process Lianyungang 222001 China 

出 版 物：《Chinese Journal of Natural Medicines》 (中国天然药物（英文版）)

年 卷 期：2018年第16卷第5期

页      面：366-374页

核心收录：

学科分类：0710[理学-生物学] 1007[医学-药学(可授医学、理学学位)] 100704[医学-药物分析学] 1005[医学-中医学] 1002[医学-临床医学] 0703[理学-化学] 10[医学] 

基　　金：supported by a grant from the National Ministry of Science and Technology(No.2013ZX09402203) 

主　　题：Risk management Near-infrared Mid-infrared Desorbing process Ginkgolide A Ginkgolide B 

摘      要：Analysis errors can occur in the desorbing process of ginkgo diterpene lactone meglumine injection(GDMI) by a conventional analysis method, due to several factors, such as easily crystallized samples, solvent volatility, time-consuming sample pre-processing, fixed method, and offline analysis. Based on risk management, near-infrared(NIR) and mid-infrared(MIR) spectroscopy techniques were introduced to solve the above problems with the advantage of timely analysis and non-destructive nature towards samples. The objective of the present study was to identify the feasibility of using NIR or MIR spectroscopy techniques to increase the analysis accuracy of samples from the desorbing process of GDMI. Quantitative models of NIR and MIR were established based on partial least square method and the performances were calculated. Compared to NIR model, MIR model showed greater accuracy and applicability for the analysis of the GDMI desorbing solutions. The relative errors of the concentrations of Ginkgolide A(GA) and Ginkgolide B(GB) were 2.40% and 2.89%, respectively, which were less than 5.00%. The research demonstrated the potential of the MIR spectroscopy technique for the rapid and non-destructive quantitative analysis of the concentrations of GA and GB.