Identification of critical process parameters of Jinqing alcohol precipitation of Reduning Injection by big data.
10.19540/j.cnki.cjcmm.20191219.301
- Author:
Hui DU
1
;
Bing XU
2
;
Fang-Fang XU
3
;
Xin ZHANG
3
;
Qing WANG
1
;
Chun-Yan XIA
1
;
Le-Wei BAO
3
;
Zhen-Zhong WANG
3
;
Yan-Jiang QIAO
2
;
Wei XIAO
4
Author Information
1. Nanjing University of Chinese Medicine Nanjing 210023, China Jangsu Kanion Pharmaceutical Co., Ltd. Lianyungang 222001, China.
2. Department of Chinese Medicine Information Science, Beijing University of Chinese Medicine Beijing 102400, China.
3. Jangsu Kanion Pharmaceutical Co., Ltd. Lianyungang 222001, China State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process Lianyungang 222001, China National & Local Joint Engineering Research Center on Intelligent Manufacturing of Traditional Chinese Medicine Lianyungang 222001, China Key Laboratory of New Technology for Extraction and Refining of Traditional Chinese Medicine Lianyungang 222001, China.
4. Nanjing University of Chinese Medicine Nanjing 210023, China Jangsu Kanion Pharmaceutical Co., Ltd. Lianyungang 222001, China State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process Lianyungang 222001, China National & Local Joint Engineering Research Center on Intelligent Manufacturing of Traditional Chinese Medicine Lianyungang 222001, China Key Laboratory of New Technology for Extraction and Refining of Traditional Chinese Medicine Lianyungang 222001, China.
- Publication Type:Journal Article
- Keywords:
Jinqing alcohol precipitation;
Reduning Injection;
big data;
critical process parameter;
quality transfer mechanism
- MeSH:
Alcohols;
Big Data;
Drugs, Chinese Herbal/chemistry*;
Solvents;
Technology, Pharmaceutical
- From:
China Journal of Chinese Materia Medica
2020;45(2):233-241
- CountryChina
- Language:Chinese
-
Abstract:
Lonicerae Japonicae Flos and Artemisiae Annuae Herba(LA or Jinqing) alcohol precipitation has various process parameters and complex process mechanism, and is one of the key units for manufacturing Reduning Injection. In order to identify the critical process parameters(CPPs) affecting the weight of the extract produced from the alcohol precipitation process, 259 batches of historical production data from 2017 to 2018 were collected, with a total of 829 318 data points. These data showed characteristics of large data, such as a large data volume, a low value density, and diverse sources. The data cleaning and feature extraction were first performed, and 48 feature variables were selected. The original data points were reduced to 9 936. Then, a combination of Pearson correlation analysis and grey correlation analysis were used to screen out 15 potential critical process parameters(pCPPs). After that, the partial least squares(PLS) was used in prediction of the weight of the extract, proving that the performance of predictive model based on 15 pCMAs is equivalent to that of predictive model based on 48 feature variables. The variable importance in projection(VIP) index was used to identify 9 CPPs, including 2 alcohol precipitation supernatant volume parameters, 4 initial extract weight parameters and 3 added alcohol volume parameters. As a result, the number of data points was 1 863, accounting for 0.28% of the original data. The big data analysis approach from a holistic point of view can effectively increase the value density of the original data. The critical process parameters obtained can help to accurately describe the quality transfer mechanism of the Jinqing alcohol precipitation process.
