对中药类保健食品认识及研究开发策略.docVIP

对中药类保健食品认识及研究开发策略 　　[摘要]中药类保健食品契合了大健康和治未病的发展要求，在养生保健、提高对疾病抵抗能力方面发挥着重要的作用，在市场上占有非常重要的地位，因此，有必要对中药类保健食品加以深入研究和探讨。首先，通过比较、分析和总结，笔者认为中药类保健食品可以定义为以中药标准控制的中药为主要原料，配方组成依据中医药理论，经过安全性和功能性评价的保健食品；其特点为安全性比药品高、生物活性比普通食品强、剂型多样、原料丰富、监管一体化。其次，该文探讨了中药类保健食品的研究开发策略和规律，指出其研发的核心任务是配方、工艺和质量标准的研究，申报和生产的基本原则是科学性、合理性、真实性和一致性；总结了其评审的安全性、功能性和可控性三大核心要求以及研发的过程管理和风险控制要点。最后，该文从中药类保健食品的注册及备案、原料、功能等方面分析了相关政策法规的动态走向并提出了有关建议。该文对全面认识中药类保健食品及其研究开发具有指导意义。 　　[关键词]中药保健食品； 研究开发； 申报评审； 风险控制； 政策法规 　　[Abstract]Health food containing Chinese materia medica （CMM） conforms to the development demands of the age of big health and the theory of preventive treatment. In the view of health care and improvement of resisting diseases， it plays an important role in the market. It is very necessary to have further study and discussion on health food containing CMM. First of all， by comparing， analyzing and summarizing， the health food containing CMM could be defined as the health food which is qualified in security and functionality evaluation， with the traditional Chinese medicines（TCM） within TCM standards as the main raw materials， and the formulation-composition is based on the theory of TCM. It is characterized by higher safety than medicines， stronger biological activities than common food， multiple forms， abundant raw materials and integrated supervision and management. Secondly， we discussed the research and development （RD） strategies and rules of health food containing CMM， pointing out that the core tasks of RD include the investigation of formula， technology and the standards of quality. The fundamental principles of declaration and production include scientificity， rationality， reality and uniformity. Three key requirements （security， functionality and controllability） in the review as well as the process management of RD and the key-points of risks control were summarized in this paper. Finally， the dynamic trends of policies and regulations related to health food containing CMM were analyzed in the vi