中药药品英文说明书撰写的研究综述与今后研究方向的探讨

A Review on English Package Insert Writing of Traditional Chinese Drug and a Discussion on Its Future Research Direction

目的:综述英文中药药品说明书撰写的研究现状、探索今后的研究方向。方法:在CNKI网站中收集英文中药药品说明书的相关论文,通过图、表、文献分析等方法归纳总结这些论文在不同杂志的分布情况、每年发表的论文数量、作者的学术背景、论文采取的研究方法、论文研究内容以及理论支撑、说明书存在的问题等。进而,通过对美国相关法规和食品保健品说明书的检索与分析,探讨了出口中药的英文说明书撰写的今后研究方向。结果:论文提出的英文中药药品说明书存在的主要问题是英译标准不统一、可读性差、望文生义、内容缺失和漏译等,主要表现在说明书的结构和结构词、药品名称和功效语部分上。发表在核心期刊上的论文少,实证研究更少,绝大多数研究者的医药学背景差、药事管理知识缺如。缺乏对出口目的国的相关法规和相关说明书的研究的论文,缺乏对把草本药品看做食品保健品的国家的相关法规和保健品说明书的研究论文。结论:英文的中药说明书要根据出口目的国的法规、参考出口目的国的相关说明书实例来撰写。中药出口至把草本药品看做药品的国家时,说明书就要撰写成药品说明书,出口至把草本药品看作是食品保健品的国家时,说明书就要撰写成保健品说明书。中药药品说明书翻译与撰写的研究重点应该转向研究出口目的国的法规原文、相关国家的相关企业的药品和保健品说明书的实例上。

Objective： To review English package insert writing on traditional Chinese drug and to discuss its future research direction. Methods： The papers related to English package insert writing on traditional Chinese drug were retrieved through CNKI. Then, the distribution of these papers in journals, the number of these papers published each year, author＇s academic background, research methods, research aspects, and supporting theories, and the problems of the inserts were summarized by means of figures, tables and document analysis. Furthermore, future research direction for the insert writing on traditional Chinese drug for export was discussed through the analysis of related laws and regulations of the United States for package insert and dietary supplement labels. Results： The main problems of the package inserts noticed by these papers are no uniformed translation standard, poor readability, translation based on literal understanding, lack or missing of information, etc., which appeared in the sections of structure, sub heading, drug name, function and indication of the insert. The papers published in the core journals or based on empirical studies were relatively few, vast majority of researchers had poor medical or pharmaceutical background, and had no knowledge of pharmacy administration. There is no research on the laws and regulations for package insert writing or the writing of dietary supplement label of destination countries, or the countries where herbs are treated as dietary supplements. Conclusions： English package insert on traditional Chinese drug should be written according to the laws and regulations of destination countries, and with reference to their package insert . Drug package English insert is appropriate for traditional Chinese drug to be exported to the countries where Chinese herbs are treated as drugs, and dietary supplement English label is suitable for the same traditional Chinese drug to be exported to the countries where herbs are treated as dietary supplement. The research focus of writing package insert or dietary supplement label for traditional Chinese drug should be changed onto the related laws and regulations of destination countries, and onto the examples of package insert and dietary supplement label of related companies in the related countries.