| 高妍,过立农,马双成,刘杰,郑健,昝珂.民族药对照药材的研制难点分析与策略探讨[J].中国药事,2020,34(1):53-57 |
| 民族药对照药材的研制难点分析与策略探讨 |
| Analysis of the Difficulties and Discussion of Strategies in the Development of Reference Medicinal Materials of Ethnic Drugs |
| 投稿时间：2019-08-13 |
| DOI：10.16153/j.1002-7777.2019.01.008 |
| 中文关键词: 民族药 对照药材 研制难点 研制策略 |
| 英文关键词: ethnic drug reference medicinal materials difficulty strategy |
| 基金项目:国家科技重大专项（编号2018ZX09735-006）；中医药行业科研专项“中药饮片质量保障系统研究（一）”资助（编号201507002） |
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| 中文摘要: |
| 目的：为民族药对照药材研制工作的顺利开展提供可行策略。方法：分析民族药对照药材研制工作中的难点问题，主要包括原料收集难度大、鉴定困难、标准不完善以及研究基础薄弱等方面。结果：在符合国家药品标准物质研制要求的前提下，提出民族药对照药材切实可行的研制方案，包括原料收集与遴选方法、生药学鉴定、理化标定、均匀性考察和稳定性考察方法。结论：民族药对照药材的研制工作起步晚、基础弱、困难多，但对民族药质量评价与监管具有极其重要的意义，也可为民族药科研工作的顺利开展奠定基础。 |
| 英文摘要: |
| Objective: To provide strategies for development of reference medicinal materials of ethnic drugs. Methods: The difficulties during the development of reference medicinal materials of ethnic drugs, including difficulties of raw material collection and identification, imperfect standards, weak researches etc were analyzed. Results: The development scheme of reference medicinal materials of ethnic drugs was proposed, including raw material collection and selection mehods, pharmacognostical identification, physical and chemical inspection, uniformity and stability test according to the requirements of the development of national drug reference materials. Conclusion: Although the research and development of reference medicinal materials of ethnic drugs had weak foundation with many difficulties, and started late, this work is of great significance to the quality evaluation and supervision of ethnic drugs, and can also lay the foundation for the research and development of ethnic drugs. |
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