在药品质量源于设计(Quality by Design,QbD)框架下,工艺控制策略是用于确保产品质量和工艺性能符合预期目标的一套计划性控制方法和步骤的组合。工艺控制策略的先进程度取决于对药品和制药工艺的理解和相关知识水平的积累。目前,国内...在药品质量源于设计(Quality by Design,QbD)框架下,工艺控制策略是用于确保产品质量和工艺性能符合预期目标的一套计划性控制方法和步骤的组合。工艺控制策略的先进程度取决于对药品和制药工艺的理解和相关知识水平的积累。目前,国内制药工艺控制正经历从质量源于检验(QbT)模式向QbD模式的转变。本文总结并比较了分别由美国FDA的Lawrance Yu和国际制药工程协会PQLI工作组提出的工艺控制策略等级模型。介绍了药物产品质量实时放行测试、工艺设计空间、工艺前馈控制和反馈控制、工艺闭环控制、工艺智能控制等先进工艺控制方法和策略,及其在中药和药品生产中的应用。展开更多
The hysteresis characteristic is the major deficiency in the positioning control of magnetic shape memory alloy actuator. A Prandtl-Ishlinskii model was developed to characterize the hysteresis of magnetic shape memor...The hysteresis characteristic is the major deficiency in the positioning control of magnetic shape memory alloy actuator. A Prandtl-Ishlinskii model was developed to characterize the hysteresis of magnetic shape memory alloy actuator. Based on the proposed Prandtl-Ishlinskii model, the inverse Prandtl-Ishlinskii model was established as a feedforward controller to compensate the hysteresis of the magnetic shape memory alloy actuator. For further improving of the positioning precision of the magnetic shape memory alloy actuator, a hybrid control method with hysteresis nonlinear model in feedforward loop was proposed. The control method is separated into two parts: a feedforward loop with inverse Prandtl-Ishlinskii model and a feedback loop with neural network controller. To validate the validity of the proposed control method, a series of simulations and experiments were researched. The simulation and experimental results demonstrate that the maximum error rate of open loop controller based on inverse PI model is 1.72%, the maximum error rate of the hybrid controller based on inverse PI model is 1.37%.展开更多
文摘在药品质量源于设计(Quality by Design,QbD)框架下,工艺控制策略是用于确保产品质量和工艺性能符合预期目标的一套计划性控制方法和步骤的组合。工艺控制策略的先进程度取决于对药品和制药工艺的理解和相关知识水平的积累。目前,国内制药工艺控制正经历从质量源于检验(QbT)模式向QbD模式的转变。本文总结并比较了分别由美国FDA的Lawrance Yu和国际制药工程协会PQLI工作组提出的工艺控制策略等级模型。介绍了药物产品质量实时放行测试、工艺设计空间、工艺前馈控制和反馈控制、工艺闭环控制、工艺智能控制等先进工艺控制方法和策略,及其在中药和药品生产中的应用。
基金Project(51105170) supported by the National Natural Science Foundation of ChinaProject supported by the Scientific Research Foundation for the Returned Overseas Chinese Scholars,Ministry of Education,China
文摘The hysteresis characteristic is the major deficiency in the positioning control of magnetic shape memory alloy actuator. A Prandtl-Ishlinskii model was developed to characterize the hysteresis of magnetic shape memory alloy actuator. Based on the proposed Prandtl-Ishlinskii model, the inverse Prandtl-Ishlinskii model was established as a feedforward controller to compensate the hysteresis of the magnetic shape memory alloy actuator. For further improving of the positioning precision of the magnetic shape memory alloy actuator, a hybrid control method with hysteresis nonlinear model in feedforward loop was proposed. The control method is separated into two parts: a feedforward loop with inverse Prandtl-Ishlinskii model and a feedback loop with neural network controller. To validate the validity of the proposed control method, a series of simulations and experiments were researched. The simulation and experimental results demonstrate that the maximum error rate of open loop controller based on inverse PI model is 1.72%, the maximum error rate of the hybrid controller based on inverse PI model is 1.37%.
