前馈控制方法及其在丹红注射液醇沉工艺品质提升中的应用(4)
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(1.Pharmaceutical Informatics Institute， Zhejiang University， Hangzhou 310058， China；
2. Heze Buchang Pharma Co.， Ltd.， Heze 274000， China)
[Abstract] In this work， a feedforward control strategy basing on the concept of quality by design was established for the manufacturing process of traditional Chinese medicine to reduce the impact of the quality variation of raw materials on drug. In the research， the ethanol precipitation process of Danhong injection was taken as an application case of the method established. Box-Behnken design of experiments was conducted. Mathematical models relating the attributes of the concentrate， the process parameters and the quality of the supernatants produced were established. Then an optimization model for calculating the best process parameters basing on the attributes of the concentrate was built. The quality of the supernatants produced by ethanol precipitation with optimized and non-optimized process parameters were compared. The results showed that using the feedforward control strategy for process parameters optimization can control the quality of the supernatants effectively. The feedforward control strategy proposed can enhance the batch-to-batch consistency of the supernatants produced by ethanol precipitation.
[Key words] quality by design； feedforward control； Danhong injection； ethanol precipitation
doi：10.4268/cjcmm20131104
[责任编辑 曹阳阳]
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