摘 要
陕西省医保目录中外科中成药说明书规范性研究
学院名称：医药学院
专业名称：中药学
学生姓名：朱林
指导教师：廖予菲
二〇一九年六月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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根据《药品说明书和标签管理规定》和《中成药非处方药说明书规范细则》以及相关法律法规对陕西省医保报销目录中外科用药中成药说明书书写规范情况进行统计分析。本次调查结果显示在调查的中成药说明书中很多对指导临床用药具有重要作用的项目标注率较低。主要问题有：1.不良反应项标示量少,明确写出不良反应的药品只有15.7％。2.只有31.3%中成药说明书对禁忌症这个重要项目进行了标注,大部分中成药说明书的禁忌症使用尚不明确表述。3.特殊人群包括孕妇、哺乳期妇女、老人，儿童等，用药并未单独列出。4.临床试验包括药物相互作用、药代动力学，药理毒理等缺少研究。这表明陕西省医保报销目录中外科用药中成药说明书内容不够详细或不完整，严重影响临床医师安全合理用药，同时对指导患者正确服用药物存在极大隐患。中成药说明书作为一份向医师及广大患者传达药品本身信息同时具有法律效力的文书，是医师开处方和广大患者安全用药的重要依据，必须按相关规定书写。建议药企咨询相关医药专家，根据《药品说明书和标签管理规定》要求列出药品说明书所对应的全部标注内容，同时相关行政主管部门要加强监管审批力度。
Abstract
According to the provisions of the Provisions on the Instructions for Use and the Management of the Label and the Rules for the NonPrescription Drugs of the Chi *景先生毕设|www.jxszl.com +Q: @351916072@ 
nese Patent Medicine and the relevant laws and regulations, the specification of the written specification of the Chinese patent medicine for surgical treatment in the medical insurance reimbursement directory of Shaanxi Province shall be analyzed and analyzed. The results of this investigation show that there are many project labeling rates that have an important role in guiding the clinical medication in the Chinese patent specification for investigation. There are mainly 1. The number of adverse reaction items is small, and only 15.7% of the drug with adverse reaction is clearly written. Only 31.3% of the instructions of the Chinese patent medicine are marked for this important item of contraindication, and the contraindications of most of the Chinese patent medicine instructions are used. Indefinite expression.3. The special population includes pregnant women, breastfeeding women, old people, children and the like, and the drugs are not listed separately. 4.The clinical trials included lack of research on drug interaction, pharmacokinetics, and pharmacological and toxicological effects. This indicates that the contents of the Chinese patent medicine in the medical insurance reimbursement catalog of Shaanxi Province are not detailed or incomplete, which seriously affects the safe and rational use of the clinical doctors, and also has great hidden trouble for guiding the patients to take the medicine correctly. The patent specification of the Chinese patent medicine, as an instrument for communicating the information of the medicine itself to the physician and the large number of patients at the same time, has the legal effect, is an important basis for the physician to prescribe medicine and the safety of a large number of patients, and must Write in accordance with the relevant provisions. It is recommended that the drugenterprise consult the relevant medical experts, and set out all the labeling contents corresponding to the instructions of the drug according to the requirements of the Provisions on the Instructions for Use and the Management of the Label, and the relevant administrative departments shall strengthen the supervision and approval.

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