Applying risk management to analytical methods for the desorbing process of ginkgo diterpene lactone meglumine injection.
10.1016/S1875-5364(18)30069-4
- Author:
Fang-Fang XU
1
,
2
;
Yu-An BI
3
;
Wen-Zhe HUANG
3
;
Zhen-Zhong WANG
4
,
5
;
Wei XIAO
1
,
6
,
7
Author Information
1. Nanjing University of Traditional Chinese Medicine, Nanjing 210000, China
2. Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222000, China.
3. Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222000, China.
4. Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222000, China
5. State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China.
6. Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222000, China
7. State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China. Electronic address: xiaoweixffxff@163.com.
- Publication Type:Journal Article
- Keywords:
Desorbing process;
Ginkgolide A;
Ginkgolide B;
Mid-infrared;
Near-infrared;
Risk management
- MeSH:
Chemistry, Pharmaceutical;
methods;
standards;
Drug Compounding;
standards;
Drugs, Chinese Herbal;
analysis;
chemistry;
standards;
Ginkgolides;
analysis;
chemistry;
standards;
Injections;
Lactones;
analysis;
Least-Squares Analysis;
Meglumine;
analysis;
chemistry;
standards;
Reproducibility of Results;
Risk Management;
Spectrophotometry, Infrared;
standards
- From:
Chinese Journal of Natural Medicines (English Ed.)
2018;16(5):366-374
- CountryChina
- Language:English
-
Abstract:
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.
