药品生产批号及有效期标注方式标准化研究
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  • 英文篇名:Standardization of Mark Method of Batch Number and Validity Period of Drugs
  • 作者:林卡娜 ; 施芳红 ; 李浩 ; 黄诗颖 ; 张顺国 ; 陈敏玲
  • 英文作者:LIN Kana;SHI Fanghong;LI Hao;HUANG Shiying;ZHANG Shunguo;CHEN Minling;Shanghai Children' s Medical Center Affiliated to Shanghai Jiaotong University School of Medicine;Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine;
  • 关键词:药品 ; 生产批号 ; 有效期 ; 标注方式 ; 标准化 ; 药品监管
  • 英文关键词:drug;;batch number;;validity period;;mark method;;standardization;;drug administration
  • 中文刊名:YYGZ
  • 英文刊名:China Pharmaceuticals
  • 机构:上海交通大学医学院附属上海儿童医学中心;上海交通大学医学院附属仁济医院;
  • 出版日期:2019-01-05
  • 出版单位:中国药业
  • 年:2019
  • 期:v.28;No.476
  • 基金:九三学社上海市委参政议政课题[zb064];; 上海交通大学中央高校基本科研业务费资助项目[17JCYB11]
  • 语种:中文;
  • 页:YYGZ201901025
  • 页数:3
  • CN:01
  • ISSN:50-1054/R
  • 分类号:91-93
摘要
目的为我国药品生产批号及有效期规范化管理提供参考。方法统计上海交通大学医学院附属上海儿童医学中心所有药品的生产批号及有效期印制方式,并进行汇总分析。针对日常药品生产批号及有效期管理中遇到的问题,提出规范化改进建议。结果医院药品生产批号及有效期印制方式以墨印(占44. 31%)和钢印(占39. 07%)为主;印制位置以包装开口处为主(占72. 16%);药品有效期以"月"表示的占66. 32%,15种药品以"有效期至(Exp.)"表示,现有药品有效期表示方式易产生歧义。结论我国现有药品生产批号及有效期制度需进行优化及细化。
        Objective To provide reference for the standardization management of the batch number and the validity period of the drugs in China. Methods The printing methods of the batch numbers and validity period of all drugs in Shanghai Children' s Medical Center Affiliated to Shanghai Jiaotong University School of Medicine were summarized and statistically analyzed. According to the problems encountered in the management of the batch number of daily drugs, the suggestions for the standardization and improvement of the batch number and validity period of the drugs were put forward. Results The printing method of drug batch number and validity of all drugs in the hospital was mainly printed ink( 44. 31%) and steel seal( 39. 07%). The printing position was mainly at the opening of the packaging( 72. 16%). The validity period of the drugs expressed as ″month″ accounted for 66. 32%. 15 drugs were expressed as″ Exp. ″. The current expression of validity period of drugs was easily ambiguous. Conclusion The current system of batch number and validity period of drugs in China needs to be optimized and refined.
引文
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