| 吴承云,刘嘉,高碧玉.药品贮藏规范化探究[J].中国药事,2020,34(1):63-70 |
| 药品贮藏规范化探究 |
| On the Standardization of Drug Preservation |
| 投稿时间：2019-07-17 |
| DOI：10.16153/j.1002-7777.2020.01.010 |
| 中文关键词: 药品 标准 贮藏 包装与储存 规范化 |
| 英文关键词: drug specifications preservation packaging and storage standardization |
| 基金项目: |
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| 中文摘要: |
| 目的：探究药品贮藏的实质及当前存在的问题，提出规范化建议。方法：采用归纳分析方法，比较分析药典凡例、制剂通则中贮藏的术语及其规定，分析药品标准中贮藏内容及存在问题。结果：药品贮藏的实质是包装与储存，存在术语界定不清、定义不细、品种贮藏内容不严谨、不平衡、不规范、缺项等问题。结论：药品标准及说明书中贮藏内容不规范是发展中的历史遗留问题，需要科学、合理定义包装与储存术语，规范地修订、完善药品包装储存内容，建立包装与储存、包材、有效期的关联，实现药品全生命周期的管理。基于药品生产、流通、使用现状，提出了药品储存条件确定的综合评估思路及规范化建议。 |
| 英文摘要: |
| Objective: To explore the features of drug preservation and existing problems and put forward some suggestions for the standardization of drug preservation. Methods: Inductive analysis method was used to compare and analyze the terms and provisions for drug preservation in General Notices and General Requirements for Preparations of Chinese Pharmacopoeia. The contents of drug preservation and existing problems in drug specifications were analyzed. Results: The essence of drug preservation was packaging and storage. There were a series of problems needed to be improved, such as ambiguous definition of terms, poor definitions, the imprecision, imbalance, lack of standardization, and item missing of storage's contents. Conclusion: The nonstandardized contents of the drug specifications and instructions is an issue left over by history. Packing and preservation terms need to be scientifically and reasonably defined, and contents of drug packing and storage need to be improved. The links between packaging and storage, packaging materials and expiration date should be established to realize the life cycle management on drugs. Based on the current status of drug production, distribution and usage, a comprehensive evaluation idea and standardization suggestions for the determination of drug preservation conditions are proposed. |
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