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中药注射剂质量控制的研究进展
引用本文:刘睿.中药注射剂质量控制的研究进展[J].中国执业药师,2013,10(3):37-42.
作者姓名:刘睿
作者单位:天津中医药大学中药学院,天津300193
基金项目:天津市高等学校科技发展基金计划项目(20110215),教育部高等学校博士学科点专项科研基金项目(20121210120001)
摘    要:中药注射剂是我国独创的新剂型,其药效迅速、疗效提高,在危重急病、疑难重症等治疗上应用广泛。然而,随着中药注射剂的广泛应用,临床不良反应频繁出现,安全性问题越来越突出。本文系统查阅近年来中药注射剂质量控制方面的相关文献,并从原料药材因素、制剂工艺因素、中药注射液质量标准体系的建立三个层面对中药注射剂质量控制的研究情况进行综述。

关 键 词:中药注射剂  质量标准  不良反应

Research Progress of the Quality Control of Traditional Chinese Medicine Injections
Authors:Liu Rui
Institution:Liu Rui (College of Traditional Chinese Medicine of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China )
Abstract:Traditional Chinese Medicine (TCM) injections are the new kinds of preparations originally created in China and have been widely used in the treatment of some severe and acute diseases with rapid and high curative effects. With the extensive application of TCM injections, the clinical adverse reactions occurred frequently, therefore safety issues are be- coming more and more prominent. On the basis of the literature review of the quality control of TCM injections, an introduc- tion was made in this paper of the research progress of the quality control of TCM injections and the factors of traditional Chinese herbs,the preparation technology and the establishment of quality control standards of TCM injections were described.
Keywords:TCM Injections  Quality Standard  Adverse Reaction
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