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data-driven engineering framework with AI algorithm of Ginkgo Folium tablets manufacturing

Acta Pharmaceutica Sinica B 2023年第5期13卷 2188-2201页

作者： Lijuan Ma Jing Zhang Ling Lin Tuanjie Wang Chaofu Ma Xiaomeng Wang Mingshuang Li Yanjiang Qiao Yongxiang Wang Guimin Zhang Zhisheng Wu Beijing University of Chinese Medicine Engineering Research Center for Pharmaceutics of Chinese Materia Medica and New Drug DevelopmentMinistry of EducationBeijing 100029China Jiangsu Kanion Pharmaceutical Co. Ltd.State Key Laboratory of New Technology in Pharmaceutical Process of Traditional Chinese MedicineLianyungang 222001China Yangtze River Pharmaceutical(Group)Co. Ltd.State Pharmaceutical Engineering Technology Research Center of Traditional Chinese MedicineTaizhou 225321China Lunan Pharmaceutical Group Co. Ltd.State Key Laboratory of Generic Technology of Traditional Chinese MedicineLinyi 276005China

Smart manufacturing still remains critical challenges for pharmaceutical manufacturing.Here,an original data-driven engineering framework was proposed to tackle the challenges.Firstly,from sporadic indicators to five kinds of systematic quality characteristics,nearly 2,000,000 real-world data points were successively characterized from Ginkgo Folium tablet manufacturing.Then,from simplex to the multivariate system,the digital process capability diagnosis strategy was proposed by multivariate C_(pk)integrated Bootstrap-t.The C_(pk)of Ginkgo Folium extracts,granules,and tablets were discovered,which was 0.59,0.42,and 0.78,respectively,indicating a relatively weak process capability,especially in granulating.Furthermore,the quality traceability was discovered from unit to end-to-end analysis,which decreased from 2.17 to 1.73.This further proved that attention should be paid to granulating to improve the quality characteristic.In conclusion,this paper provided a data-driven engineering strategy empowering industrial innovation to face the challenge of smart pharmaceutical manufacturing.

关键词： Smart manufacturing data-driven engineering Artificial intelligence Information fusion Process capability index End-to-end Quality traceability Real-world Ginkgo Folium products

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