摘 要通过系统的对中成药说明书进行缺项分析和项目内容分析中发现:中成药说明书中存在内容上缺斤少两，并没有严格参照国家颁布的法规文件去书写内容，尤其在禁忌、不良反应、注意事项这些项目中存在的问题尤为严重，不良反应项目是所有项目中标注率最低的。在缺项分析研究中发现不良反应项目有实质内容的情况平均有25%，禁忌项目为40%。其中片剂在禁忌、不良反应、注意事项这些项目中有实质内容的标注率最高，口服液的最低。而在标注为尚不明确的样本说明书中进行不同的厂家横向对比发现不同厂家对一种药品项目的标注也不同，除了以上问题还存在药理毒性、药代动力学、临床实验、特殊人群用药项目的缺失，没有相关的研究。研究中成药说明书所存在的一些问题是为促成中成药说明书完整、规范、便于患者阅读，提供参考的重要意义。中成药说明书项目需要整改、内容需更加完善、法律法规需要进一步的修订，为确保患者放心、安全、合理的用药。
2018版基本药物目录中内科中成药说明书规范性研究
二 级 学 院：医药学院
专 业 名 称：中药学
学 生 姓 名：侯星宇
指 导 教 师：廖予菲
二○一九年六月
郑 重 声 明
本人呈交的学位论文，是在导师的指导下，独立进行研究工作所取得的成果，所有数据、图片资料真实可靠。尽我所知，除文中已经注明引用的内容外，本学位论文的研究成果不包含他人享有著作权的内容。对本论文所涉及的研究工作做出贡献的其他个人和集体，均已在文中以明确的方式标明。本学位论文的知识产权归属于培养单位。
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随机收集《国家基本药物目录》（2018年版）中部分内科中成药说明书，根据《药品说明书和标签管理规定》和《国家基本药物目录管理办法（暂行）》对说明书各项内容进行调查分析，重点调查缺项和不完整项。将收集到的药品进行处方与非处方药的分类，非处方药在国家药监局官方网站中存在范本，收集范本用所收集到的这些范本与样本进行说明书项目的比对。
The instructions of some proprietary Chinese medicines in internal medi *景先生毕设|www.jxszl.com +Q: @351916072@ 
cine in the National catalogue of essential drugs (2018 edition) were randomly collected. According to the regulations on the Administration of Drug instructions and labels and the measures for the Administration of basic drugs catalogue (interim), the contents of the instructions are investigated and analyzed, with emphasis on the investigation of missing items and incomplete items. The collected drugs were classified as prescriptions and overthecounter drugs, and models of overthecounter drugs were present on the official website of the State Drug Administration. The collected models were compared with the samples for specification items.
Through the systematic analysis of the missing items of the Chinese patent medicine specification and the analysis of the project content, it is found that there are two deficiencies in the Chinese patent medicine specification, and there is no strict reference to the legal documents promulgated by the state to write the content, especially in taboos. The problems in these items are particularly serious, and the adverse reaction items are the lowest among all the projects. In the analysis of missing items, it was found that the average content of adverse reaction items was 25%, and that of taboo items was 40%. Among them, the labeling rate of tablets in taboos, adverse reactions and matters needing attention was the highest, and that of oral liquid was the lowest. And in In addition to the above problems, there are pharmacological toxicity, pharmacokinetics and clinical experiments, which are also found to be different by different manufacturers in the horizontal comparison of different manufacturers in the sample specification, which is not yet clear. There is no related research on the lack of drug use items in special population.
Some problems in the study of proprietary Chinese medicine instructions are of great significance for promoting the integrity, standardization and convenience of patients reading of proprietary Chinese medicine instructions. Proprietary Chinese medicine specification items need to be rectified, the content needs to be more perfect, laws and regulations need to be further revised, in order to ensure patients rest assured, safe and reasonable use of drugs.

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