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| Process quality control for digital pharmaceutical manufacturing of Danhong injection based upon material flow analysis |
| Hits 1583 Download times 1378 Received:July 14, 2015 |
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| DOI
10.11656/j.issn.1673-9043.2015.06.09 |
| Key Words
Danhong injection;Digital pharmaceutical manufacturing;Process quality control;Material flow analysis |
| Author Name | Affiliation | | LI Zheng | State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | PAN Wan-fang | Zhejiang Dayuan Intelligent Pharmaceutical Engineering Company LTD, Hangzhou 311100, China | | ZHU Li-ming | Zhejiang Dayuan Intelligent Pharmaceutical Engineering Company LTD, Hangzhou 311100, China | | JIANG Yi | Zhejiang Dayuan Intelligent Pharmaceutical Engineering Company LTD, Hangzhou 311100, China | | WANG Chen-chen | Shandong Buchang Pharmaceutical Company Limited, Heze 274000, China | | ZHAO Tao | Shandong Buchang Pharmaceutical Company Limited, Heze 274000, China | | ZHAO Bu-chang | Shandong Buchang Pharmaceutical Company Limited, Heze 274000, China |
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| Abstract
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| [Objective] It is the objective of this study to analyze the material in process using HPLC and UV spectroscopyto elucidate the material change and transfer mechanism. We aim to developing a methodology to identify critical process and parameters for statistical quality control (SPC) models to enhance the batch-to-bath quality consistency of Danhong injection.[Methods] The concentrations of 9 main chemical components and UV spectroscopy were collected for 32 batches and 7 stages of the manufacturing process of Danhong injection. The batch-to-batch quality consistency for each stage was evaluated based on the relative standard deviation (RSD) of each chemical component. The material change phenomenon was studied by evaluating the yield ratio of each chemical component and the mass balance to identify the influence of each stage on the chemical components. The SPC models were established with PCA analysis of the HPLC and UV spectroscopy data respectively, with PC1 score, Hotelling-T2 and DModXused as index for quality monitoring. [Results] The major chemical components demonstrated good consistency in the multistage process of Danhong injection manufacturing with RSD less than 10%. Mass balance analysis indicates chemical reactions of Salvianolic acid A and physical transfer for other components. [Conclusion] Mass flow analysis of Danhong injection process elucidated the material change and transfer mechanism. We identified critical process for Danhong injection and established quality monitoring models for each stage. |
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