浅析2010 年版《 中国药典》(一部) 增修订情况及其临床指导意义.docVIP

·中药论坛· 浅析2010 年版《中国药典》 一部）增修订情况及其临床指导意义 张碧华＊，高素强，傅得兴（卫生部北京医院药学部，北京 100730）  中图分类号 R288；R921.2  文献标志码  C  文章编号 1001-0408（2013）23-2113-03 DOI 10.6039/j.issn.1001-0408.2013.23.01  摘 要  目的：了解 2010 年版《中国药典》 一部）增修订情况，探讨其对于临床用药的指导意义。方法：将 2010 年版《中国药典》 （一部）与历版《中国药典》进行对比，总结新版增、修订特点，以及药材饮片增、修订情况。结果：2010 年版《中国药典》 一部）共收 载品种 2 165 个，新增品种 1 019 个（包括 439 个饮片标准），修订 634 种；收载品种、饮片标准大幅增加，药品标准更为合理，药品安 全性更强，加入了新的检测技术和方法，附录更完善；许多药材的拉丁名、药用部位、功能主治、剂量、服用方法、注意事项得到了修 订。结论：2010 年版《中国药典》客观体现了我国药物检测技术发展水平及临床用药的特点，使药品监督管理的力度和信度、效度 在安全性和可控性方面都有了更大提升，对于提高中药饮片和中成药的质量，保障临床用药的安全有效，规范中药产业的发展，均 将起到积极作用。 关键词 2010 年版；中国药典；收载品种；药品标准；中药饮片 Analysis of the Additional and Revised Description of 2010 Edition of Chinese Pharmacopoeia（Volume）and Its Clinical Guiding Significance ZHANG Bi-hua，GAO Su-qiang，FU De-xing（Dept. of Pharmacy，Beijing Hospital，Department of Public Heal- th，Beijing 100730，China）  ABSTRACT  OBJECTIVE：To sum up the additional and revised description of 2010 edition of Chinese Pharmacopoeia（volume ），and to discuss its guiding significance for clinical rational drug use. METHODS：2010 edition of Chinese Pharmacopoeia（vol- ume ） was compared with different editions chinese pharmaiopoeias，The characteristic of addtion and revision in volume 1 of Chinese Pharmacopeia as well as TCM decoction piece were summed up. RESULTS：There were 2 165 varieties recorded in the Chi- nese Pharmacopoeia，among which 1 019 varieties were new added （including 439 decoction pieces standards） and 634 varieties were revised. Recorded species，decoction pieces standard was increased significantly，drug standard was more reasonable，and drug safety was stronger，new detection techniques and methods was adopted and appendix of the standard was further improved. Latin names，medicinal parts，indications of the function，dosage，route of administration and attention of many herbs had been re- vised.CONCLUSIONS：2010 edition of Chinese Pharmacopoeia embody the development level of the drug check in China and the character o