| 引用本文:王云1，宋亚南1,2，张村1.中药饮片保质期与有效期文献计量学分析[J].世界中医药,2022,(18):. |
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| 中药饮片保质期与有效期文献计量学分析 |
| Bibliometric Analysis of Shelf Life and Validity Period of Chinese Medicine Decoction Pieces |
| 投稿时间：2022-01-25 |
| DOI：10.3969/j.issn.1673-7202.2022.18.012 |
| 中文关键词: 中药 饮片 有效期 保质期 效期 调研 |
| English Keywords:Chinese medicine Decoction pieces Validity period Shelf life Expiry date Survey |
| 基金项目:国家药品监督管理局药品注册司委托研究课题——中药饮片设定保质期调研报告（Z2019024） |
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| 中文摘要: |
| 目的：对中药保质期或有效期进行系统的调研，探讨中药饮片设定保质期或有效期的依据及其必要性，为提高中药饮片质量、保障临床用药安全提供技术支撑，为药品监管部门制定有关法规提供科学依据。方法：以国家知识基础设施数据库（CNKI）为数据来源，采用文献计量学研究方法，选用检索词为“中药材”并“有效期”“饮片”并“有效期”，“饮片”并“保质期”“中药材”并“保质期”“中药材”并“效期”和“饮片”并“效期”，利用CNKI平台工具以及Excel统计工具进行统计分析。结果：经数据库检索、筛选，获取中药材、饮片保质期或有效期或效期的相关有效文献共85篇，其中关于中药、饮片保质期的相关文献26篇，中药、饮片有效期或效期的相关文献59篇；在59篇关于中药有效期的文献中，74.58%的文献对于中药是否应该制定有效期、如何制定有效期等展开了讨论，25.42%的文献为中药有效期研究的实验性文献。结论：本文从中药材、饮片保质期与有效期的现状，质量评价指标，研究方法，饮片分类、保质期制定的必要性，及其存在的问题和建议等方面进行了梳理和归纳，为中药饮片保质期制定，提供了详实的文献依据。 |
| English Summary: |
| To systematically investigate the shelf life or validity period of Chinese medicine,explore the basis and necessity of setting the shelf life or validity period of Chinese medicine decoction pieces,thereby providing technical support for improving the quality of Chinese medicine and ensuring the safety of the clinical medication and the scientific basis for the formulation of relevant laws and regulations by the drug regulatory department.Methods:Taking China National Knowledge Infrastructure(CNKI) as the data source and adopting the bibliometric research method,the retrieval words were selected as “Chinese medicine” and “validity period”,“decoction pieces” and “validity period”,“decoction pieces” and “shelf life”,“Chinese medicine” and “shelf life”,“Chinese medicine” and “expiry date”,and “decoction pieces” and “expiry date”,and CNKI platform tools and Excel were used for statistical analysis.Results:Through database retrieval,85 valid papers related to the shelf life,validity period,or expiry date of Chinese medicine and decoction pieces were obtained,including 26 papers related to the shelf life of Chinese medicine and decoction pieces and 59 papers related to the validity period or expiry date of Chinese medicine and decoction pieces.Of the 59 papers on the validity period of Chinese medicine,74.58% discussed whether and how to formulate the validity period of Chinese medicine,and 25.42% were experimental articles on the study of the validity period of Chinese medicine.Conclusion:This paper summarizes the current situation of the shelf life and validity period of Chinese medicine and decoction pieces,quality evaluation indicators,research methods,classification of decoction pieces,necessity of formulating the shelf life,as well as the existing problems and suggestions,which provides a detailed literature basis for the research and formulation of the shelf life of Chinese medicine decoction pieces. |
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