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论中药质量源于设计
重要小贴士
Important tips:
中药大品种联盟近期正在征集专家库成员，我们殷切欢迎有技术、有能力、有经验，愿意为中药大品种培育、为中药产业贡献力量的优秀人才，加入中药大品种联盟。详细信息请查看平台功能栏【专家报名】中的通知，或直接点击文章最下方阅读原文进行报名。
Herbal varieties of big league in the near future are solicited expert panel members, we should welcome technology, have the ability and experience, willing to large varieties breeding for traditional Chinese medicine, make contributions to Chinese traditional medicine industry of outstanding talent, to join Chinese medicine big league. Please refer to the notification in the platform function column, or click directly below the article to sign up.
⊙作者：徐冰、史新元、吴志生、张燕玲、王耘、乔延江
Author: xu bing, shi xin yuan, wu zhisheng, zhang yanling, wang yun, qiao yan jiang
1985年，著名质量管理学家Joseph M. Julan博士在总结其质量管控经验和方法的基础上，提出质量源于设计（quality by design，QbD），与Deming的质量十四点原则和PDCA循环、Feigenbaum的全面质量管理（TQC）、今井正明的持续改善（Kaizen）等方法和理念共同奠定了现代质量管理的基础。进入21世纪，人用药品注册技术国际协调会（ICH）认识到科学知识可提高产品开发和控制的自由度，并于2003年成立质量专家工作组（EWG），针对创建新的适用于产品生命周期的制药质量体系达成一致认识。2005年，在ICH Q8指南中定义了制药质量源于设计，旨在将先进的管理学原则和以科学为本的药品研发制造规律融合集成，以提高药品质量，更好地保护患者利益。
In 1985, the famous scientist Joseph m. quality management in Dr Julan concluded on the basis of its quality control experience and methods, puts forward the quality is the result of design, quality by design, QbD), and the quality of the Deming's ten to four principles and the PDCA cycle, total quality management (TQC) Feigenbaum, imai is Ming method such as continuous improvement (Kaizen) and common laid the foundation of modern quality management concept. Entering the 21st century, people with drug registration technology international event (for example) to realize scientific knowledge can improve the product development and control of degrees of freedom, and in 2003 set up quality expert working group (EWG), to create a new applicable to the pharmaceutical quality system of product life cycle to reach an agreement. In 2005, defined in ICH Q8 guide the pharmaceutical quality from design, to advanced management principles and the scientific integration for the regularity of drug research and development manufacturing fusion, in order to improve the drug quality, to better protect the interests of patients.
中药作为我国独特和具有原创优势的卫生资源，在防病治病和健康服务中发挥着重要作用。与化学药品相比，中药原料质量的不确定性、物质基础和生产工艺的复杂性、以及中药质量标准和临床疗效之间的模糊性，增加了中药研发和生产实施QbD的难度。自2013年起，国内部分高校、中药制药企业和监管机构就QbD在中药生产工艺、中药质量标准制定和质量控制、以及中药二次开发中的应用进行了若干前瞻性思考，但尚未形成一致的认识和模式。本文尝试在分析QbD核心思想的基础上，提出符合中医药自身规律和特点的中药QbD模式，为QbD在中药研究中的应用提供参考。
As a unique and original health resource, traditional Chinese medicine plays an important role in preventing and treating diseases and health services. Compared with the chemical, the uncertainty of raw material quality, material base and the complexity of the production process, the traditional Chinese medicine and the quality standard and clinical curative effect, the ambiguity between the increased the difficulty of the traditional Chinese medicine research and development and production implement QbD. Since 2013, some domestic colleges and universities, Chinese medicine pharmaceutical companies and regulators QbD in traditional Chinese medicine, Chinese medicine quality standard formulation and production process quality control, and the application of the secondary development of a number of proactive thinking, but has not yet formed a consistent understanding and the pattern. This paper tries to based on the analysis of the QbD core idea, put forward in accordance with its own rules and characteristics of traditional Chinese medicine of traditional Chinese medicine QbD mode, provide reference for QbD in the application of traditional Chinese medicine research.
Important tips:
中药大品种联盟近期正在征集专家库成员，我们殷切欢迎有技术、有能力、有经验，愿意为中药大品种培育、为中药产业贡献力量的优秀人才，加入中药大品种联盟。详细信息请查看平台功能栏【专家报名】中的通知，或直接点击文章最下方阅读原文进行报名。
Herbal varieties of big league in the near future are solicited expert panel members, we should welcome technology, have the ability and experience, willing to large varieties breeding for traditional Chinese medicine, make contributions to Chinese traditional medicine industry of outstanding talent, to join Chinese medicine big league. Please refer to the notification in the platform function column, or click directly below the article to sign up.
⊙作者：徐冰、史新元、吴志生、张燕玲、王耘、乔延江
Author: xu bing, shi xin yuan, wu zhisheng, zhang yanling, wang yun, qiao yan jiang
1985年，著名质量管理学家Joseph M. Julan博士在总结其质量管控经验和方法的基础上，提出质量源于设计（quality by design，QbD），与Deming的质量十四点原则和PDCA循环、Feigenbaum的全面质量管理（TQC）、今井正明的持续改善（Kaizen）等方法和理念共同奠定了现代质量管理的基础。进入21世纪，人用药品注册技术国际协调会（ICH）认识到科学知识可提高产品开发和控制的自由度，并于2003年成立质量专家工作组（EWG），针对创建新的适用于产品生命周期的制药质量体系达成一致认识。2005年，在ICH Q8指南中定义了制药质量源于设计，旨在将先进的管理学原则和以科学为本的药品研发制造规律融合集成，以提高药品质量，更好地保护患者利益。
In 1985, the famous scientist Joseph m. quality management in Dr Julan concluded on the basis of its quality control experience and methods, puts forward the quality is the result of design, quality by design, QbD), and the quality of the Deming's ten to four principles and the PDCA cycle, total quality management (TQC) Feigenbaum, imai is Ming method such as continuous improvement (Kaizen) and common laid the foundation of modern quality management concept. Entering the 21st century, people with drug registration technology international event (for example) to realize scientific knowledge can improve the product development and control of degrees of freedom, and in 2003 set up quality expert working group (EWG), to create a new applicable to the pharmaceutical quality system of product life cycle to reach an agreement. In 2005, defined in ICH Q8 guide the pharmaceutical quality from design, to advanced management principles and the scientific integration for the regularity of drug research and development manufacturing fusion, in order to improve the drug quality, to better protect the interests of patients.
中药作为我国独特和具有原创优势的卫生资源，在防病治病和健康服务中发挥着重要作用。与化学药品相比，中药原料质量的不确定性、物质基础和生产工艺的复杂性、以及中药质量标准和临床疗效之间的模糊性，增加了中药研发和生产实施QbD的难度。自2013年起，国内部分高校、中药制药企业和监管机构就QbD在中药生产工艺、中药质量标准制定和质量控制、以及中药二次开发中的应用进行了若干前瞻性思考，但尚未形成一致的认识和模式。本文尝试在分析QbD核心思想的基础上，提出符合中医药自身规律和特点的中药QbD模式，为QbD在中药研究中的应用提供参考。
As a unique and original health resource, traditional Chinese medicine plays an important role in preventing and treating diseases and health services. Compared with the chemical, the uncertainty of raw material quality, material base and the complexity of the production process, the traditional Chinese medicine and the quality standard and clinical curative effect, the ambiguity between the increased the difficulty of the traditional Chinese medicine research and development and production implement QbD. Since 2013, some domestic colleges and universities, Chinese medicine pharmaceutical companies and regulators QbD in traditional Chinese medicine, Chinese medicine quality standard formulation and production process quality control, and the application of the secondary development of a number of proactive thinking, but has not yet formed a consistent understanding and the pattern. This paper tries to based on the analysis of the QbD core idea, put forward in accordance with its own rules and characteristics of traditional Chinese medicine of traditional Chinese medicine QbD mode, provide reference for QbD in the application of traditional Chinese medicine research.
