| 引用本文:钟莉沙1,2，钟雨禅2，赵军宁3，戴瑛3，华桦3，杨安东3，张翼冠3，宋相容1.基于川产道地药材及经典名方的美国膳食补充剂开发思路与路径[J].世界中医药,2020,(02):. |
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| 基于川产道地药材及经典名方的美国膳食补充剂开发思路与路径 |
| Research and Development Thinking and Path of American Dietary Supplement Based on Sichuan Genuine Medicinal Materials and TCM Classical Famous Prescriptions |
| 投稿时间：2020-01-09 |
| DOI：10.3969/j.issn.1673-7202.2020.02.013 |
| 中文关键词: 川产道地药材 经典名方 美国膳食补充剂 中医药国际化 姜黄 养精种玉汤 膳食补充剂健康教育法案 天然产品 |
| English Keywords:Sichuan genuine medicinal materials(Sichuan Dao-di herbs) TCM classic famous prescriptions American dietary supplements TCMInternationalization Tumeric YangjingZhongyuDecoction Dietary Supplement Health and Education Act Natural Product |
| 基金项目:国家重大新药创制专项[2011ZX09401-304(4-2)];国家中医药管理局中医药保健品国际研究开发平台项目(A-2017N-41);四川省科技厅科技支撑计划项目(2013SZ0115);四川省科技厅重点研发项目(2018SZ0056);四川省科学技术厅国际合作计划项目(2016HH0003);国家中医药管理局推进中国-南盟合作框架下的中医药与南亚传统医药产业国际化合作发展研讨项目(A-2017-58);四川省中医药管理局川产道地药材大品种培育四川省中医药产业创新团队项目(2017C008);2017年中医药公共卫生服务补助专项(财社〔2017〕66号);2018年中医药公共卫生服务补助专项(财社〔2018〕43号) |
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| 中文摘要: |
| 川产道地药材在中国道地药材资源中占有重要地位,以品种多、分布广、产量大、质量优为其特点,经典名方的安全性和有效性在中医药临床中经历了千年实践验证,是中医学传承中最有价值的部分。美国食品药品监督管理局(FDA)对膳食补充剂的管理方式和政策机制,为中药经典名方进入美国膳食补充剂市场提供了一条可行的路径。本文根据美国FDA对膳食补充剂的管理方式和本团队前期工作基础,概述了以基于川产道地药材及经典名方转化为美国膳食补充剂的思路的操作思路和方法,通过对FDA法规的分析为中医药走入国际市场提供政策依据,以实例为中医院进入国际市场提供可供借鉴的成功案例。 |
| English Summary: |
| Sichuan genuine medicinal materials play an important role in the resources of TCM materials，characterized by their variety，wide distribution，high yield and excellent quality.The safety and effectiveness of the classic prescriptions have been verified by thousands of years of practice in the clinical practice of TCM，which is the most valuable part of the medical heritage of China.The FDA's management of dietary supplements and its policy mechanism provide a feasible path for TCM classic prescriptions to enter the American dietary supplement market.Based on the FDA's requirements of dietary supplements and the basis of the team's previous work，this paper summarizes the operational ideas and methods based on the idea of converting TCM materials and classic prescriptions into American dietary supplements.Through the analysis of FDAregulations to provide the policy basis for TCM to enter the international market，to provide examples for TCM to enter the international market practice. |
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