120种骨伤科常用中成药说明书规范性研究
摘 要
收集骨伤科常用中成药说明书进行分析，为骨伤科医师在临床上规范使用中成药品提供理论支持。收集和整理出《国家基本药物目录》(2018年版)中收载和临床上骨伤科常用的中成药说明书共120份。根据国家食品药品监督管理局发布的《药品说明书和标签管理规定》和国家药品说明书范本，对所收集到的骨伤科中成药说明书进行比较。可知骨伤科中成药说明书中存在如下问题:1.在缺项分析研究中禁忌项目平均标注率为50%，不良反应项目为40%。其中酒剂在禁忌、不良反应项目中标注率最高，散剂的最低。2.在成分项中未完全标注出所有内容，出现说明书中标明有15味药材，而实际只列出了11味药材，其余4味药材并未列出，最后用“等”代替的现象。3.在特殊人群用药这一研究项目中所研究的药品普遍标注率较低，并且在51种OTC甲类的药品中有31种药品有缺项，标注不完整；在22种OTC乙类的药品中有11种药品有缺项，标注不完整；而在47种处方药中这方面问题较少。4.在骨伤科中成药多含药性峻烈或乌头、马钱子等毒性成分，而在此次研究中药理毒理这方面标注率最低，其标注率为0，并且没有相关警示语。通过研究表明在骨伤科中成药说明书中成分、不良反应、禁忌、特殊人群用药、药理毒理等方面存在着较大问题。
The manual of proprietary Chinese medicine was collected and analyzed in order to provide theoretical support for orthopedic doctors to standardize the use of proprietary Chinese medicine in clinic. A total of 120 proprietary Chinese medicine instructions were collected and sorted out in the National catalogue of essential drugs (2018 edition) and commonly used in orthopaedics department. According to the regulations on the Administration of Drug ins *好棒文|www.hbsrm.com +Q: &351916072&
tructions and labels issued by the State Food and Drug Administration and the model national drug instructions, the collected specifications of proprietary Chinese medicines in orthopaedics department were compared. It can be seen that there are the following problems in the specification of proprietary Chinese medicine in orthopaedics department. 1. The average labeling rate of taboo items in the analysis and study of missing items is 50%, and the adverse effects are negative. The project should be 40%. Among them, the label rate of alcohol agent is the highest in taboo and adverse reaction items, and the lowest of powder is .2. all the contents are not completely marked in the ingredient item, and there are 15 medicinal materials in the manual, but only 11 medicinal materials are listed in practice. The remaining four medicinal materials are not listed and are finally replaced by "equal". 3.the general labeling rate of the drugs studied in the special population research project is low, and 31 of the 51 OTC class A drugs are missing. Incomplete marking; Of the 22 OTC B drugs, 11 were missing and incompletely marked, while 47 were found to be missing. In the prescription, there are fewer problems in this respect. 4.In the Department of Orthopaedics, most of the proprietary Chinese medicines contain toxic components such as aconite or aconite, but in this study, the labeling rate of traditional Chinese medicine Li Toxicology is the lowest, the marking rate is 0, and there is no relevant warning sign. The results showed that there were some problems in the instructions of traditional Chinese patent medicine in orthopedic department, such as composition, adverse reactions, taboos, special population use, pharmacological toxicology and so on.
收集骨伤科常用中成药说明书进行分析，为骨伤科医师在临床上规范使用中成药品提供理论支持。收集和整理出《国家基本药物目录》(2018年版)中收载和临床上骨伤科常用的中成药说明书共120份。根据国家食品药品监督管理局发布的《药品说明书和标签管理规定》和国家药品说明书范本，对所收集到的骨伤科中成药说明书进行比较。可知骨伤科中成药说明书中存在如下问题:1.在缺项分析研究中禁忌项目平均标注率为50%，不良反应项目为40%。其中酒剂在禁忌、不良反应项目中标注率最高，散剂的最低。2.在成分项中未完全标注出所有内容，出现说明书中标明有15味药材，而实际只列出了11味药材，其余4味药材并未列出，最后用“等”代替的现象。3.在特殊人群用药这一研究项目中所研究的药品普遍标注率较低，并且在51种OTC甲类的药品中有31种药品有缺项，标注不完整；在22种OTC乙类的药品中有11种药品有缺项，标注不完整；而在47种处方药中这方面问题较少。4.在骨伤科中成药多含药性峻烈或乌头、马钱子等毒性成分，而在此次研究中药理毒理这方面标注率最低，其标注率为0，并且没有相关警示语。通过研究表明在骨伤科中成药说明书中成分、不良反应、禁忌、特殊人群用药、药理毒理等方面存在着较大问题。
The manual of proprietary Chinese medicine was collected and analyzed in order to provide theoretical support for orthopedic doctors to standardize the use of proprietary Chinese medicine in clinic. A total of 120 proprietary Chinese medicine instructions were collected and sorted out in the National catalogue of essential drugs (2018 edition) and commonly used in orthopaedics department. According to the regulations on the Administration of Drug ins *好棒文|www.hbsrm.com +Q: &351916072&
tructions and labels issued by the State Food and Drug Administration and the model national drug instructions, the collected specifications of proprietary Chinese medicines in orthopaedics department were compared. It can be seen that there are the following problems in the specification of proprietary Chinese medicine in orthopaedics department. 1. The average labeling rate of taboo items in the analysis and study of missing items is 50%, and the adverse effects are negative. The project should be 40%. Among them, the label rate of alcohol agent is the highest in taboo and adverse reaction items, and the lowest of powder is .2. all the contents are not completely marked in the ingredient item, and there are 15 medicinal materials in the manual, but only 11 medicinal materials are listed in practice. The remaining four medicinal materials are not listed and are finally replaced by "equal". 3.the general labeling rate of the drugs studied in the special population research project is low, and 31 of the 51 OTC class A drugs are missing. Incomplete marking; Of the 22 OTC B drugs, 11 were missing and incompletely marked, while 47 were found to be missing. In the prescription, there are fewer problems in this respect. 4.In the Department of Orthopaedics, most of the proprietary Chinese medicines contain toxic components such as aconite or aconite, but in this study, the labeling rate of traditional Chinese medicine Li Toxicology is the lowest, the marking rate is 0, and there is no relevant warning sign. The results showed that there were some problems in the instructions of traditional Chinese patent medicine in orthopedic department, such as composition, adverse reactions, taboos, special population use, pharmacological toxicology and so on.
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