基于中药质量树的中药饮片全程质量控制和管理系统的开发

中药饮片全程质量控制和管理是一个系统工程,全程涉及基地环境、种子种苗、采收加工等多个环节,因此准确识别中药生产过程可能诱发质量风险的因素,及其合理的质量控制措施非常重要。目前,质量风险理念主要集中在管理、法规等方面。尚无针对中药饮片质量过程中各环节可能出现风险的综合分析及其切实的质量控制方案的分析总结。该文提出一种基于中药质量树的中药饮片全程质量控制和管理系统。该系统将中药质量树这种过程分析方法与质量风险管理有效结合,在实现中药全程质量过程控制的同时可帮助管理者实时决策。中药饮片全程质量控制和管理工作流系统通过提供个性化web界面。可实现面向用户的信息反馈,方便用户进行中药质量预测、风险评估和调控。在实施应用过程中,中药饮片全程质量控制和管理系统将基地环境、栽培和饮片加工各环节质量相关因素标识出来,可依据企业自身的生产条件扩展、修改现有的科学工作流,提供给不同的企业自己专属的质量体系,做到个性化服务。作为一种全新的质量管理模式,该文可为提升中药生产质量,实现质量标准化提供参考。

Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization.