国家药品评价抽验是通过对相关产品的调研、标准检验、探索性研究等系统性的分析与评价,来充分揭示相关中药品种的现行质量状况,为中药的质量监管提供服务。笔者在研究历年中药国家评价抽验工作的基础上,通过对有关资料的总结、归纳与整理,提炼出与中药质量控制有关的信息,以便为今后中药质量评价的工作思路、工作方法提供参考。
Abstract
Through systematic analysis and evaluation of the RESULTS of products survey, standard inspection and exploratory study, evaluation inspection CONCLUSION can offer a good reference for traditional Chinese medicine quality regulation. The informations related to quality control of TCM were extracted by analyzing and summarizing relevant documents of quality evaluation in recent years and this paper is trying to provide these informations to the people with traditional Chinese medicine quality evaluation, so that they can get some helps in conceiving work design and making work plan for traditional Chinese medicine quality evaluation inspection.
关键词
中药 /
抽验 /
评价 /
质量 /
有效性 /
安全性
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Key words
Chinese patent medicine /
sampling inspection /
evaluation /
quality /
effectiveness /
security
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中图分类号：
R917
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参考文献
LI Y Z. Chinese medicine adverse reaction should not be ignored.Chin Pharm Aff (中国药事),2003, 17(7): 406-409.
MEI Q X, ZENG C Y. On the event of “exigent Withdrawal of Houttuynia Cordata Injection”. J China Pharm(中国药房),2006, 17(15): 1124-1126.
YUAN L P, MA L M. Revaluation the safety of traditional Chinese medicine injections. Chin J New Drugs (中国新药杂志),2007, 16(21): 1738-1741.
JIANG L, RAO W W. The research progress of Chinese medicinal dyeing and adulteration .Cap Med(首都医药),2007, 16(21): 16-18.
MA C H, SHAN Z G, QI J W. The research progress of Chinese medicinal dyeing and adulteration . Asia-Pacific Tradit Med(亚太传统医药),2011, 7(2): 153-154.
CHEN L X. Mycotoxins and their research progress . Hebei J Ind Sci Technol (河北工业科技),2006, 23(2): 124-126.
LI J Y, WANG L, YANG M H. Limit standard of mycotoxins and advances in studies on its application in Chinese materia medica. Chin Tradit Herb Drugs (中草药),2011, 42(3): 602-609.
ZHANG J Q, LIU M S, XING F S, et al. Research situation of pesticide residue in herbal drugs in recent years.Chin Pharm J (中国药学杂志),2003, 38(1): 7-9.
ZHENG C, MEI D, WANG L, et al. Focus on adverse reactions of excipient in preparations.Chin Pharm J(中国药学杂志),2005, 40(9): 644-649.
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脚注
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基金
国家十二五“重大新药创制”专项(2014ZX09304307-002)
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