云南省直接口服粉末饮片政策研究

Study on the Policy of Direct Oral Powder Decoction Pieces in Yunnan Province

目的:了解当前云南省直接口服粉末饮片的发展现状,明确其在生产、质量控制、监管三个方面存在的主要问题,分析产生问题的原因,提出政策建议。方法:实地调研云南省规模以上的两家直接口服粉末饮片生产企业,了解直接口服粉末饮片在生产、质量控制方面存在的主要问题;调研云南省药品监管行业专家,询问监管方面存在的问题及建议,分析问题产生的原因,形成调研记录;查阅直接口服粉末饮片相关文献、法律法规和政策文件,分析调研记录。结果:当前云南省直接口服粉末饮片存在标准老化等三个问题,建议云南省相关部门尽快组织修订《云南省中药饮片标准》(2005年版)及补充标准,加强监管力度,促进市场良性竞争,加强产品稳定性研究,以促进该类饮片健康发展。结论:直接口服粉末饮片大健康产品的品种应当限定在药食同源、可用于保健食品和云南省特色药材范围内。在标准完成修订、实现有效监管的情况下,直接口服粉末饮片的安全性和有效性是可控的。

Objective:To understand the current development status of direct oral powder decoction pieces in Yunnan Province,to clarify the main problems in production,quality control,and supervision,to analyze the reasons for the problems,and to propose policy recommendations.Methods:The researchers conducted field research on two direct oral powder decoction pieces manufacturers above the scale in yunnan province about the major problems in the production and quality control of direct oral powder decoction pieces.Then,Experts in drug regulatory industry in yunnan province were investigated,asked about problemsand Suggestions in supervision,analyzed the causes of problems,and made records.Relevant literatures,laws,regulations and policy documents related to direct oral powder decoction pieces were consulted,and research records were analyzed to obtain research results.Results:The study made clear that at present,thereare three problems such as standard aging in direct oral powder decoction pieces in yunnan province,It is recommended that relevant departments in Yunnan Province organize the revision of the"Yunnan Provincial Standard for Chinese Medicine Decoction Pieces"(2005 edition)and supplementary Standards as soon as possible to strengthen supervision,promotehealthy market competition,and strengthen Study on the stability of the product to promote the healthy development.Conclusion:The study finally showed tha the varieties of direct oral powder decoction large health products should be limited to the medicine and food homology,which can be used in health foods and Yunnan specialty medicinal herbs.The safety and effectiveness can be controlled under the condition that the standard is revised and effective supervision is achieved.