108种消化道疾病常用中成药说明书规范性研究
摘 要药品说明书不仅作为医生使用药品为患者减轻病症的科学依据，也作为生产该药品的厂家对媒体对市场介绍其功能主治和其他特性的主要宣传手段,说明书的规范性程度是与其医疗质量构成正比。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23%，禁忌项目为41%。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。所以研究中成药说明书是对其药品的临床意义和现实的存在价值有着重要的意义。针对消化道疾病中成药说明书存在的一些缺项进行研究，从消化道疾病患者的角度出发来研究消化道疾病常用中成药说明书中存在隐患或描述不清的项目。消化道疾病常用中成药种类繁多，而其药品说明书大多都存在或多或少的缺项，本次通过收集消化道疾病患者较常用的108种消化道疾病中成药的说明书来进行研究讨论，针对消化道疾病中成药说明书存在的不足之处，提出一些可行的改进的建议。
收集《2018版基本药物目录》中和市面常用消化道疾病中成药说明书，根据国家食品药品监督管理局制定的《药品说明书和标签管理规定》《国家基本药物目录制度》《中药、天然药物处方药说明书格式》对各项内容进行统计分析消化道疾病常用中成药说明书中存在的不规范性部分。
Abstract
In this paper, 108 kinds of Chinese patent medicines for digestive tract diseases were collected, and the irregularities were analyzed. Collect the instructions of Chinese patent medicine for digestive tract diseases in the 2018 edition of Esse *好棒文|www.hbsrm.com +Q: &351916072&
ntial Medicines Catalogue and the market. According to the Regulations on the Administration of Pharmaceutical Instructions and Labels, the National Essential Medicines Catalogue System and the Format of Prescription Pharmaceutical Instructions for Traditional Chinese Medicine and Natural Medicines formulated by the State Food and Drug Administration, analyze the contents of the instructions of Chinese patent medicine for digestive tract The nonnormative part.
Pharmaceutical instructions are not only the scientific basis for doctors to use drugs to alleviate patientsillness, but also the main propaganda means for manufacturers to introduce their functions and other characteristics to the market. The standardization of the instructions is in direct proportion to their medical quality. Therefore, it is of great significance to study the instructions of traditional Chinese medicine for its clinical significance and practical existence value. Through the systematic analysis of the missing items and the project content analysis of the Chinese patent medicine specification, 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, adverse reactions, matters needing attention in these items, and the adverse reaction items are the lowest of all the items. In the analysis of missing items, it was found that the average content of adverse reaction items was 23%, and that of taboo items was 41%. 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 the sample specification which is not yet clear, it is found that the marking of a drug item is also different by different manufacturers. In addition to the above problems, there are also pharmacological toxicity, pharmacokinetics, clinical trials, the lack of drug use items in special population, and there is no related research.
The main contents and methods of this study are to study some deficiencies in the instructions of Chinese patent medicines for digestive tract diseases and to study the hidden dangers or unclear descriptions in the instructions of Chinese patent medicines commonly used for digestive tract diseases from the perspective of patients with digestive tract diseases. There are many kinds of Chinese patent medicines commonly used in digestive tract diseases, and most of them have more or less deficiencies in their drug instructions. In this study, 108 kinds of Chinese patent medicines commonly used in patients with digestive tract diseases were collected and discussed. In view of the shortcomings of the Chinese patent medicines instructions for digestive tract diseases, some feasible suggestions for improvement were put forward.
收集《2018版基本药物目录》中和市面常用消化道疾病中成药说明书，根据国家食品药品监督管理局制定的《药品说明书和标签管理规定》《国家基本药物目录制度》《中药、天然药物处方药说明书格式》对各项内容进行统计分析消化道疾病常用中成药说明书中存在的不规范性部分。
Abstract
In this paper, 108 kinds of Chinese patent medicines for digestive tract diseases were collected, and the irregularities were analyzed. Collect the instructions of Chinese patent medicine for digestive tract diseases in the 2018 edition of Esse *好棒文|www.hbsrm.com +Q: &351916072&
ntial Medicines Catalogue and the market. According to the Regulations on the Administration of Pharmaceutical Instructions and Labels, the National Essential Medicines Catalogue System and the Format of Prescription Pharmaceutical Instructions for Traditional Chinese Medicine and Natural Medicines formulated by the State Food and Drug Administration, analyze the contents of the instructions of Chinese patent medicine for digestive tract The nonnormative part.
Pharmaceutical instructions are not only the scientific basis for doctors to use drugs to alleviate patientsillness, but also the main propaganda means for manufacturers to introduce their functions and other characteristics to the market. The standardization of the instructions is in direct proportion to their medical quality. Therefore, it is of great significance to study the instructions of traditional Chinese medicine for its clinical significance and practical existence value. Through the systematic analysis of the missing items and the project content analysis of the Chinese patent medicine specification, 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, adverse reactions, matters needing attention in these items, and the adverse reaction items are the lowest of all the items. In the analysis of missing items, it was found that the average content of adverse reaction items was 23%, and that of taboo items was 41%. 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 the sample specification which is not yet clear, it is found that the marking of a drug item is also different by different manufacturers. In addition to the above problems, there are also pharmacological toxicity, pharmacokinetics, clinical trials, the lack of drug use items in special population, and there is no related research.
The main contents and methods of this study are to study some deficiencies in the instructions of Chinese patent medicines for digestive tract diseases and to study the hidden dangers or unclear descriptions in the instructions of Chinese patent medicines commonly used for digestive tract diseases from the perspective of patients with digestive tract diseases. There are many kinds of Chinese patent medicines commonly used in digestive tract diseases, and most of them have more or less deficiencies in their drug instructions. In this study, 108 kinds of Chinese patent medicines commonly used in patients with digestive tract diseases were collected and discussed. In view of the shortcomings of the Chinese patent medicines instructions for digestive tract diseases, some feasible suggestions for improvement were put forward.
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