Lean strategy for data mining and continuous improvement of Chinese pharmaceutical process: a case study of sporoderm-removal Ganoderma lucidum spore powder.
10.19540/j.cnki.cjcmm.20221108.301
- Author:
Yi ZHONG
1
;
Xiao-Hui FAN
2
;
Zhen-Hao LI
3
Author Information
1. Longevity Valley Botanical Co., Ltd. Wuyi 321200, China Pharmaceutical Informatics Institute,College of Pharmaceutical Sciences, Zhejiang University Hangzhou 310058, China.
2. Pharmaceutical Informatics Institute,College of Pharmaceutical Sciences, Zhejiang University Hangzhou 310058, China.
3. Longevity Valley Botanical Co., Ltd. Wuyi 321200, China Longevity Valley Botanical Research Institute Co., Ltd. Hangzhou 311121, China.
- Publication Type:Journal Article
- Keywords:
Bayesian network;
Pareto multi-objective optimization;
continuous process improvement;
convolutional neural network;
data of Chinese pharmaceutical industry;
sporoderm-removal Ganoderma lucidum spore powder
- MeSH:
Bayes Theorem;
Data Mining;
Drug Industry;
Powders;
Reishi;
Spores, Fungal
- From:
China Journal of Chinese Materia Medica
2023;48(3):829-834
- CountryChina
- Language:Chinese
-
Abstract:
In the digital transformation of Chinese pharmaceutical industry, how to efficiently govern and analyze industrial data and excavate the valuable information contained therein to guide the production of drug products has always been a research hotspot and application difficulty. Generally, the Chinese pharmaceutical technique is relatively extensive, and the consistency of drug quality needs to be improved. To address this problem, we proposed an optimization method combining advanced calculation tools(e.g., Bayesian network, convolutional neural network, and Pareto multi-objective optimization algorithm) with lean six sigma tools(e.g., Shewhart control chart and process performance index) to dig deeply into historical industrial data and guide the continuous improvement of pharmaceutical processes. Further, we employed this strategy to optimize the manufacturing process of sporoderm-removal Ganoderma lucidum spore powder. After optimization, we preliminarily obtained the possible interval combination of critical parameters to ensure the P_(pk) values of the critical quality properties including moisture, fineness, crude polysaccharide, and total triterpenes of the sporoderm-removal G. lucidum spore powder to be no less than 1.33. The results indicate that the proposed strategy has an industrial application value.
