| 苏雯,西村一郎,曾庆钱.中日中药材“道地产区”药事管理法规对比研究[J].中国药事,2023,(12):1352-1361 |
| 中日中药材“道地产区”药事管理法规对比研究 |
| Comparative Study on the Pharmaceutical Management Regulations ofTraditional Chinese Medicine "Real Estate Area" in China and Japan |
| 投稿时间：2022-10-28 |
| DOI：doi:10.16153/j.1002-7777.2023.12.002 |
| 中文关键词: 中药材 道地产区 道地药材 药事管理 法律法规 |
| 英文关键词: Chinese herbal medicine real estate area real estate materials pharmacy management laws andregulations |
| 基金项目: |
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| 中文摘要: |
| 目的：中药材（日本以“生药”称谓）属于中药药品，同时又为中药制剂的原料。因自然属性，来源是否为道地产区，直接关系和影响到其自身和后续制剂产品的质量。如何通过法律法规建立起质量保证的第一道屏障，邻国日本做岀了与我国不同方向的实践。积极参考与借鉴日本的相关实践，提升我国中药材及后续制剂质量。方法：通过对中日两国现行中药材道地产区药事管理法规与实施举措的分析，比较各自的立法目的与实施法规方式、手段的异同。结果：归纳两国对中药材道地产区法规管理的本质特征及实际效果。结论：为我国中药材道地产区药事管理法规与实施举措的进一步完善，提供参考标准的理论依据。 |
| 英文摘要: |
| Objective: Chinese herbal medicine (called "Crude Medicine" in Japan) belongs to traditionalChinese medicine drugs and is also the raw material of traditional Chinese medicine preparations. Due tonatural attributes, whether the source is a genuine producing area or not is directly related to and aff ects thequality of its own and subsequent preparations. Neighboring Japan has made practice in various directions fromChina on how to establish the fi rst barrier of quality assurance through laws and regulations. To improve thequality of Chinese medicinal materials and subsequent preparations by actively referring to the relevant practiceof Japan. Methods: Through the analysis of the current laws and regulations and implementation measureson the administration of pharmaceutical aff airs in the genuine producing areas of Chinese herbal medicine inChina and Japan, the similarities and differences of their legislative purposes and implementation methodswere compared. Results: The article summarized the essential characteristics and actual effects of the lawsand regulations management of the two countries on the genuine producing areas of Chinese herbal medicine.Conclusion: It provides theoretical basis for reference standard for the further improvement of the pharmaceuticaladministration laws and regulations and the implementation measures in the genuine producing areas of Chineseherbal medicine. |
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