| 引用本文:连传运1，徐冰1，2，3，王秋平4，于佳琦1，史新元1，2，3，乔延江1，2，3.中药质量源于设计应用：工艺控制策略[J].世界中医药,2018,(03):. |
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| 中药质量源于设计应用：工艺控制策略 |
| Chinese Medicine Quality Derived From Design Methods and Applications for-(Ⅴ)：Process Control Strategy |
| 投稿时间：2017-12-13 |
| DOI：10.3969/j.issn.1673-7202.2018.03.006 |
| 中文关键词: 质量源于设计 中药 实时放行检验 前馈/反馈控制 闭环控制 |
| English Keywords:Quality by Design (QbD) Chinese medicine Real time release testing (RTRT) Feedforward and feedback control Closed-loop control |
| 基金项目:国家中药标准化项目（ZYBZH-C-QIN-45）；国家自然科学基金项目（81403112）;国家自然科学基金重点项目（81430094） |
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| 中文摘要: |
| 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。 |
| English Summary: |
| Under the framework of pharmaceutical quality by design (QbD), a process control strategy is defined as a combination of a set of planning control methods and procedures used to ensure product quality and process performance which meets expected goals. The advanced process control strategy depends on the understanding of pharmaceutical processes and the accumulation of relevant knowledge. At present, the control of the domestic pharmaceutical process is experiencing a shift from the quality by testing (QbT) mode to the QbD mode. This paper summarizes and compares the hierarchy models of process control strategy proposed by Lawrance Yu of the U.S. FDA and the PQLI working group of the International Society of Pharmaceutical Engineering. Advanced process control methods, such as realtime release testing of drug product quality, process design space, feedforward control and feedback process control, closed-loopprocess control and intelligent process control, as well as their applications in Chinese medicine and pharmaceutical production were reviewed. |
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