顺应论视角下中文药品说明书警示语规范研究

发布时间：2018-06-09 11:34

本文选题：药品说明书 + 警示语　；参考：《广东外语外贸大学》2015年硕士论文

【摘要】：尽管国家食品药品监督管理局(CFDA)于2006年颁布了《药品说明书和标签管理规定》,要求上市药品说明书和标签遵此规定。但是,市面上现存的药品说明书任然存在诸多问题,对患者的生命健康造成巨大的损害。卡马西平案、温江桂枝茯苓丸案等案例中显现出药品说明书在侵权责任方面也有很多的争论,由此引发的警示缺陷也被越来越多的药品商家所重视。因此,药品说明书亟需规范。本文研究目标如下:通过实验的方法去分析存药品说明书警示语的不规范之处;结合顺应论和人际功能分析理论,试图探讨药品说明书警示语不规范背后的动因;根据分析结果,提出一套药品说明书警示语写作的规范。本文采用定量分析和实验的方法,对119份中文药品说明书警示语做了分析,并结合药品警示语理解力实验,探究其不规范之处。研究显示,市面上现存的药品说明书存在诸多问题,主要体现在警示语言陈述不完整、语言模糊、信息不突出、表达过于专业、存在虚假信息等五个方面。在此基础上,本文提出警示语写作应遵循的指导原则,以期给药品厂家规范药品说明书带来一定的启示。
[Abstract]:Although the State Food and Drug Administration (CFDAA) issued the regulations for the Administration of Drug instructions and labels in 2006, it requires that the guidelines and labels of listed drugs be complied with. However, there are still many problems in the existing drug instructions, which cause great damage to patients' lives and health. Carmaxiping case, Wen Jiang Guizhi Fuling pill case and other cases show that drug instructions in tort liability also has a lot of controversy, resulting in warning defects have also been paid more and more attention to drug merchants. Therefore, the drug specification needs to be standardized. The research objectives of this paper are as follows: to analyze the irregularities of the warning language of drug instruction by experimental method, to explore the motivation behind the nonstandard warning language of drug instruction by combining the theory of adaptation and interpersonal function analysis; According to the results of the analysis, a set of guidelines for the writing of drug instructions warning language is proposed. By means of quantitative analysis and experiment, 119 warning words in Chinese drug instruction are analyzed, and the nonstandard of these warnings is explored in combination with the comprehension experiment of drug warning language. The research shows that there are many problems in the existing drug instructions in the market, which are mainly reflected in five aspects: incomplete statement of warning language, vague language, inconspicuous information, over-professional expression and false information. On this basis, this paper puts forward the guiding principles to be followed in the writing of warning language, in order to bring some enlightenment to drug manufacturers in standardizing drug instructions.
【学位授予单位】：广东外语外贸大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：H136

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