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中药材产地加工趁鲜切制高质量规范化发展的思考

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中药材产地加工趁鲜切制由来已久,国家药品监督管理局出台支持中药材趁鲜切制政策以来,各地区陆续发布趁鲜切制工作方案及品种目录,并开展趁鲜切制加工技术规范及质量标准研究.对《中华人民共和国药典》2020 年版收载的趁鲜切制品种和全国各地发布的趁鲜切制品种进行分析,立足趁鲜切制品种的安全性和有效性,对比产地趁鲜切制加工与传统加工方式现状,发现产地趁鲜切制加工存在加工不规范、区域间缺乏流通等问题,提出建立科学评估趁鲜切制品种的加工技术规范体系、质量标准体系、质量管理体系,旨在推动中药材产地加工趁鲜切制高质量规范化发展.
Reflections on High-quality and Standardized Development of Fresh-cut Processing of Chinese Medicinal Materials
Fresh-cut processing of Chinese medicinal materials has a long history.Since the National Medical Products Administration issued policies supporting fresh-cut processing of Chinese Medicinal Materials,various regions have issued work plans and species catalogs for fresh-cut and researched processing technical specifications and quality standards.This study analyzes the fresh-cut varieties of Chinese Medicinal Materials listed in the Pharmacopoeia of the People's Republic of China(2020 edition)and those issued by different regions Based on the safety and effectiveness,the study summarized its research status of fresh-cut processing and compared it with traditional processing methods in producing area.It also identified the existing problems,such as non-standard processing and lack of regional circulation,and put forward the establishment of a scientific evaluation system for processing technical specification system,quality standard system,and quality management,aiming to promote high-quality standardized development.

Chinese medicinal materialsfresh-cutsafetyeffectivenessexisting problemsquality system

陶冶、徐新房、魏锋、张亚中、李向日、李千、张海霞、张欣悦、姜水蓝、刘艺淇、杨超

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北京中医药大学 中药学院/国家中医药管理局中药炮制技术传承基地/中药品质评价北京重点实验室,北京 102488

安徽省食品药品检验研究院/国家药品监督管理局中药质量研究与评价重点实验室,安徽 合肥 230051

中国食品药品检定研究院,北京 102629

中药材 趁鲜切制 安全性 有效性 存在问题 质量体系

2024

中国现代中药
中国中药协会,中国医药集团总公司,中国药材公司

中国现代中药

CSTPCD
影响因子:0.65
ISSN:1673-4890
年,卷(期):2024.26(9)