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In this paper, a database of international registration standard on natural crude drugs (NCDs) and international registered varieties of NCDs was constructed. In this database, taking NCDs as the research object, and the registration status and technical requirements of NCDs were systematically searched in representative countries and regions such as the United States, the European Union, Japan, South Korea, Singapore, Hong Kong, Brazil, Malaysia and South Africa. And the main information sources, system framework design ideas, methods and characteristics of the database are described in detail. The relevant databases are expected be actively constructed to further accelerate the pace of TCM internationalization taking advantages of knowledge integration, in order to provide strong technical support for TCM to go abroad and serve the world.

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本文提出以天然药物为研究对象,系统检索美国、欧盟、日本、韩国、新加坡、中国香港地区、巴西、马来西亚、南非等代表性国家和地区的天然药物注册情况及技术要求,联合世界卫生组织草药产品注册监管联盟等机构,构建天然药物国际注册标准数据库及天然药物国际注册品种数据库。详细说明该数据库建立的主要信息来源、系统框架设计思路、方法和特点。希望能积极推动相关数据库的建设,发挥整合优势,进一步加快中医药国际化前进步伐,为中药走出国门、服务全球提供强有力技术支撑。

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金红宇,男,主任药师,主要从事中药质量控制研究。联系电话:(010)53852464,E-mail:
马双成,男,博士生导师,研究员,主要从事中药质量控制研究。联系电话:(010)53852076,E-mail:
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王赵,女,硕士,助理研究员,主要从事中药质量控制研究。联系电话:(010)53852464,E-mail:

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王赵,女,硕士,助理研究员,主要从事中药质量控制研究。联系电话:(010)53852464,E-mail:

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王赵,女,硕士,助理研究员,主要从事中药质量控制研究。联系电话:(010)53852464,E-mail:

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天然药物国际注册数据库的构建设想
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王赵 1 , 金红宇 1 , 赵剑锋 2 , 胡笑文 1 , 昝珂 1 , 马双成 1
中国新药杂志 | 重大新药创制专项巡礼 2023,32(1): 30-34
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中国新药杂志 | 重大新药创制专项巡礼 2023, 32(1): 30-34
天然药物国际注册数据库的构建设想
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王赵1 , 金红宇1 , 赵剑锋2, 胡笑文1, 昝珂1, 马双成1
作者信息
  • 1中国食品药品检定研究院,北京 102629
  • 2国家药典委员会,北京 100061
  • 王赵,女,硕士,助理研究员,主要从事中药质量控制研究。联系电话:(010)53852464,E-mail:

通讯作者:

金红宇,男,主任药师,主要从事中药质量控制研究。联系电话:(010)53852464,E-mail:
马双成,男,博士生导师,研究员,主要从事中药质量控制研究。联系电话:(010)53852076,E-mail:
Conceive of constructing a database base on the international registration of natural crude drugs
Zhao WANG1 , Hong-yu JIN1 , Jian-feng ZHAO2, Xiao-wen HU1, Ke ZAN1, Shuang-cheng MA1
Affiliations
  • 1National Institutes for Food and Drug Control, Beijing 102629, China
  • 2Chinese Pharmacopoeia Commission, Beijing 100061, China
出版时间: 2023-01-15
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本文提出以天然药物为研究对象,系统检索美国、欧盟、日本、韩国、新加坡、中国香港地区、巴西、马来西亚、南非等代表性国家和地区的天然药物注册情况及技术要求,联合世界卫生组织草药产品注册监管联盟等机构,构建天然药物国际注册标准数据库及天然药物国际注册品种数据库。详细说明该数据库建立的主要信息来源、系统框架设计思路、方法和特点。希望能积极推动相关数据库的建设,发挥整合优势,进一步加快中医药国际化前进步伐,为中药走出国门、服务全球提供强有力技术支撑。

天然药物  /  国际注册  /  数据库  /  世界卫生组织草药产品注册监管联盟

In this paper, a database of international registration standard on natural crude drugs (NCDs) and international registered varieties of NCDs was constructed. In this database, taking NCDs as the research object, and the registration status and technical requirements of NCDs were systematically searched in representative countries and regions such as the United States, the European Union, Japan, South Korea, Singapore, Hong Kong, Brazil, Malaysia and South Africa. And the main information sources, system framework design ideas, methods and characteristics of the database are described in detail. The relevant databases are expected be actively constructed to further accelerate the pace of TCM internationalization taking advantages of knowledge integration, in order to provide strong technical support for TCM to go abroad and serve the world.

natural crude drugs  /  international registration  /  database  /  WHO Alliance for regulatory Registration of Herbal Products
王赵, 金红宇, 赵剑锋, 胡笑文, 昝珂, 马双成. 天然药物国际注册数据库的构建设想. 中国新药杂志, 2023 , 32 (1) : 30 -34 .
Zhao WANG, Hong-yu JIN, Jian-feng ZHAO, Xiao-wen HU, Ke ZAN, Shuang-cheng MA. Conceive of constructing a database base on the international registration of natural crude drugs[J]. Chinese Journal of New Drugs, 2023 , 32 (1) : 30 -34 .
  • 国家“重大新药创制”科技重大专项资助项目(2018ZX 09735006)
2023年第32卷第1期
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  • 首发时间:2026-03-06
  • 出版时间:2023-01-15
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  • 录用日期:2022-07-19
基金
国家“重大新药创制”科技重大专项资助项目(2018ZX 09735006)
作者信息
    1中国食品药品检定研究院,北京 102629
    2国家药典委员会,北京 100061

通讯作者:

金红宇,男,主任药师,主要从事中药质量控制研究。联系电话:(010)53852464,E-mail:
马双成,男,博士生导师,研究员,主要从事中药质量控制研究。联系电话:(010)53852076,E-mail:
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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Genus
种数
Number of
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占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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