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目的探讨含动物类成分中成药的质量控制,以期为其标准提高、质量监督和规范生产提供参考。方法对2010~2014年国家药品抽验抽取的含动物类成分中成药的执行标准和探索性研究内容加以梳理,从安全性、真实性、有效性、可控性等角度出发,分析具体品种质量控制的技术与方法。结果高效液相、气相等色谱技术的运用日趋成熟,传统的显微鉴别和薄层鉴别方法可以在指标成分缺乏的动物药的鉴别方面发挥很好的作用,质谱联用技术已成功应用于中成药中动物药的质量控制。结论国家评价抽验能够对药品质量进行综合、细致地评价,发现潜在风险,是促进动物药质量提高的有利手段。
Objective To explore the quality control of Chinese medicine containing animal components, with a view to providing reference for the improvement of its standards, quality supervision and standardization of production. Methods The implementation standards and exploratory research contents of the Chinese patent medicines containing animal components drawn from the national drug sampling from 2010 to 2014 were reviewed. The safety and authenticity, effectiveness and controllability of the proprietary Chinese medicines were analyzed to analyze the quality control of specific cultivars Technology and methods. Results The application of high performance liquid chromatography and gas chromatography has become more and more mature. The traditional methods of microscopic identification and thin layer identification can play a very important role in the identification of animal drugs lacking in indicator components. Mass spectrometry has been successfully applied in Quality Control of Animal Medicine in Adult Drugs. Conclusion The national evaluation sampling can comprehensively and carefully evaluate the quality of medicines and find out the potential risks, which is a favorable method to promote the improvement of animal medicines quality.