基于全程质量控制理念的中药标准化体系研究思路探讨
投稿时间:2017-11-06  修订日期:2017-11-09  责任编辑:  点此下载全文
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作者中文名作者英文名单位中文名单位英文名E-Mail
董玲 DONG Ling 北京中医药大学 Beijing University of Chinese Medicine dongling@bucm.edu.cn 
孙裕 SUN Yu 兰州佛慈制药股份有限公司 Lanzhou Buddha Ci Pharmaceutical Co., Ltd.  
裴纹萱 PEI Wen-xuan 北京中医药大学 Beijing University of Chinese Medicine  
戴俊东 DAI Jun-dong 北京中医药大学 Beijing University of Chinese Medicine  
王子禹 WANG Zi-yu 北京中医药大学 Beijing University of Chinese Medicine  
潘孟 PAN Meng 北京中医药大学 Beijing University of Chinese Medicine  
陈江鹏 CHEN Jiang-peng 北京中医药大学 Beijing University of Chinese Medicine  
王耘* WANG yun 北京中医药大学 Beijing University of Chinese Medicine wangyun@bucm.edu.cn 
基金项目:国家中药标准化项目《大黄等6种中药饮片标准化建设》(ZYBZH-Y-GS-10-B)
中文摘要:药品质量源于设计,对药品生产整个生命周期的良好设计可使药品达到预期的质量要求。针对目前中药产业存在的问题,本文从国家战略层面出发,以国际制造业质量控制理念为指导,结合中药产业自身特点和发展现状,提出基于全程质量控制理念的中药标准化体系建设,其内涵是建立中药以三性指标为核心的的综合质量指标体系、中药材和饮片的质量标准和规范体系、中药质量追溯体系、中药全程质量控制数据监控系统和中药全程质量管理体系这相互关联的五个体系,通过“顶层设计—分步实施—系统整合”的工作流程实现中药产业的全过程系统科学研究。通过对各环节质量标准间系统关联性的分析,建立各环节及全程标准操作规程,构建高标准的中药产业链全面质量管理体系,为中药全程质量控制体系的构建提供示范,为中药产业的标准化提供系统性的参考和依据。
中文关键词:全程质量控制  三性指标体系  质量树模型  中药标准化
 
Discussion on research thinking of standardization strategy in TCM based on the idea of full quality control
Abstract:The concept of “Quality by design” indicates that good design for the whole life cycle of pharmaceutical production enables the drug to meet the expected quality requirements. Aiming at the existing problems of the traditional Chinese medicine (TCM) industry and starting from the national strategic level and guided by the idea of quality control in international manufacturing industry, this article put forward standardization strategy in TCM towards full quality control combined with its own characteristics and development status. The connotation of this strategy established five interrelated systems: multi-indicators system based on tri-indicators system, quality standard system, quality traceability system, data monitoring system based on full quality control and total quality management system of TCM, and“top-level design-implement in steps -system integration” workflow was employed to achieve the full process of systematic scientific study on TCM industry. This article analyzed the relevance between the quality standards of all links, established standard operating procedures of each link and full process, and constructed a high standard total quality management system of TCM industry chain, in order to provide a demonstration for the establishment of TCM full quality control system and provide systematic reference and basis for standardization strategy in TCM industry.
keywords:Full quality control  Tri-indicators system  Quality tree  Standardization strategy in TCM
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