1.AI-integrated IQPD framework of quality prediction and diagnostics in small-sample multi-unit pharmaceutical manufacturing: Advancing from experience-driven to data-driven manufacturing.
Kaiyi WANG ; Xinhai CHEN ; Nan LI ; Huimin FENG ; Xiaoyi LIU ; Yifei WANG ; Yanfei WU ; Yufeng GUO ; Shuoshuo XU ; Lu YAO ; Zhaohua ZHANG ; Jun JIA ; Zhishu TANG ; Zhisheng WU
Acta Pharmaceutica Sinica B 2025;15(8):4193-4209
The pharmaceutical industry faces challenges in quality digitization for complex multi-stage processes, especially in small-sample systems. Here, an intelligent quality prediction and diagnostic (IQPD) framework was developed and applied to Tong Ren Tang's Niuhuang Qingxin Pills, utilizing four years of data collected from four production units, covering the entire process from raw materials to finished products. In this framework, a novel path-enhanced double ensemble quality prediction model (PeDGAT) is proposed, which combines a graph attention network and path information to encode inter-unit long-range and sequential dependencies. Additionally, the double ensemble strategy enhances model stability in small samples. Compared to global traditional models, PeDGAT achieves state-of-the-art results, with an average improvement of 13.18% and 87.67% in prediction accuracy and stability on three indicators. Additionally, a more in-depth diagnostic model leveraging grey correlation analysis and expert knowledge reduces reliance on large samples, offering a panoramic view of attribute relationships across units and improving process transparency. Finally, the IQPD framework integrates into a Human-Cyber-Physical system, enabling faster decision-making and real-time quality adjustments for Tong Ren Tang's Niuhuang Qingxin Pills, a product with annual sales exceeding 100 million CNY. This facilitates the transition from experience-driven to data-driven manufacturing.
2.Effects of Modified Wendan Decoction Combined with Amlodipine Tablets on TCM Constitution and Vascular Endothelial Growth Factor of Phlegm-damp Hypertension Patients
Zhishu LU ; Jiangqin ZENG ; Fang YU ; Qinguo SUN
Chinese Journal of Information on Traditional Chinese Medicine 2015;(7):32-35
Objective To observe the clinical efficacy of modified Wendan Decoction combined with amlodipine tablets in treating hypertensive patients with phlegm-damp constitution, and the impact on patients' constitution and vascular endothelial growth factor (VEGF). Methods Totally 126 patients were randomly divided into two groups, 63 cases in each group. The treatment group was given modified Wendan Decoction combined with amlodipine tablets, while the control group received amlodipine tablets, for 12 weeks. The blood pressures, TCM phlegm-damp scores, and serum VEGF levels in both groups were observed before and after treatment. Antihypertensive effect between the two groups was compared. Results TCM phlegm-damp scores decreased significantly in the treatment group after treatment (P<0.01), while that was not significant in the control group (P>0.05). The treatment group was superior to the control group (P<0.01). The systolic blood pressure, diastolic blood pressure, and serum VEGF level significantly decreased after treatment (P<0.01), and the indicators of treatment group were better than those of the control group (P<0.05). The total efficiency of treatment group and control group were 92.1%(58/63) and 76.2%(48/63), respectively, the difference was significant (P<0.05). Conclusion Modified Wendan Decoction combined with amlodipine tablets can significantly improve biased constitution in hypertension patients with phlegm-damp constitution, lower serum VEGF level, and improve endothelial function, with good antihypertensive effect.

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