郭 青,吴晓燕,史清水,黄 青.中药注射剂质量评价的有关研究思路、方法和建议[J].药物评价研究,2010,33(5):351-360
中药注射剂质量评价的有关研究思路、方法和建议
Research ideas, methods, and proposals concerned for quality evaluation on injection of Chinese materia medica
投稿时间:2010-05-13  
DOI:10.7501/j.issn.0253-6376.[year].[issue].[sequence]
中文关键词:  中药注射剂;质量评价;研究思路;方法和建议
英文关键词:Chinese medicinal injection (CMI); quality evaluation; research ideas; methods and proposals
基金项目:
作者单位
郭 青1,吴晓燕2,史清水1,黄 青1 1 江苏省食品药品检验所,江苏 南京 210008; 2 南京中医药大学,江苏 南京 210029 
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中文摘要:
      中药注射剂近年来较频繁地出现临床不良反应,其制备不规范以及临床使用不当是主要原因,但中药注射剂质量存在安全性风险以及质量标准门槛过低也是原因之一。笔者在参加国家首批中药注射液中的脉络宁注射液评价性抽样工作过程中,收获了一些体会和研究思路,有必要归纳总结,与同行交流,并供参考。
英文摘要:
      Chinese medicinal injection (CMI) has been presenting a series of adverse drug reactions (ADRs) for recent years. The main reasons are non-normative preparation and improper clinical usage, by which there are some riskness in safety and the quality standards of CMIs are too inferior. After the research work was undertaken on Mailuoning Injection that is in the first list of CMIs to be compulsively conducted a quality evaluation by SFDA, some experiences and research ideas have been obtained, which is necessary to summarize for an academic communication and to provide a reference for similar work.
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