中国中药杂志

2007, (14) 1377-1381

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论中药质量控制与评价模式的创新与发展
Probe into innovation and development of pattern of quality control and evaluation for Chinese medicine

肖小河;金城;赵中振;肖培根;王永炎;
XIAO Xiao-he1,JIN Cheng1,ZHAO Zhong-zhen3,XIAO Pei-gen2,WANG Yong-yan4(1.PLA Institute of Chinese Meteria Medica,302 Hospital of PLA,Beijing 100039,China;2.Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences,Beijing 100094,China;3.School of Chinese Medicine,Hong Kong Baptist University,Hong Kong,China;4.China Academy of Chinese Medical Sciences,Beijing 100700,China)

摘要(Abstract):

探索建立新的中药质量控制与评价模式。通过分析现行中药质量模式的局限性,比较分析中药、化学合成药与生物制剂质量控制模式异同点,结合笔者近年来在道地药材和药性理论研究的体会,提出中药质量控制与评价的新模式。相对于化学合成药来说,中药与生物制剂在物质组成形式、质量管理模式等方面具有更大相似性,中药质量控制模式应借鉴生物制剂而不是“套用”化学合成药。提出了构建基于道地药材和生物效价检测的中药质量控制与评价模式的新设想。
To set up a new pattern of quality control and evaluation for Chinese medicine.By investigating the limitation of quality control pattern for Chinese medicine,the differences and similarities in the chemical substantial style as well as quality control patterns among Chinese medicine,chemical synthetic drugs and Biologicals,combining with the author's experience on the research of geo-authentic medicinal material and theory of Chinese medicinal nature,a new pattern of quality control for Chinese medicine has been explored and designed.A more rational pattern of quality control for Chinese medicine should be referred to Biologicals instead of chemical synthetic drugs,there are more similarity in chemical substantial style and quality control pattern for Chinese medicine between Chinese medicine and Biologicals than that between Chinese medicine and chemical synthetic drugs.Based on geo-authentic medicinal material and bioassay or biopotency detection,a new pattern of quality control for Chinese medicine could be built and applied.

关键词(KeyWords): 中药;质量控制与评价;生物效价检测;道地药材
Chinese drugs;quality control and evaluation;biopotency detetion;geo-authenticated medicinal material

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作者(Author): 肖小河;金城;赵中振;肖培根;王永炎;
XIAO Xiao-he1,JIN Cheng1,ZHAO Zhong-zhen3,XIAO Pei-gen2,WANG Yong-yan4(1.PLA Institute of Chinese Meteria Medica,302 Hospital of PLA,Beijing 100039,China;2.Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences,Beijing 100094,China;3.School of Chinese Medicine,Hong Kong Baptist University,Hong Kong,China;4.China Academy of Chinese Medical Sciences,Beijing 100700,China)

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