| 引用本文: | 陈超,訾晓伟,金立,王丹丹,俞辉.基于国家标准的药包材抽样规则合理性探讨[J].中国现代应用药学,2017,34(10):1482-1484. |
| CHEN Chao,ZI Xiaowei,JIN Li,WANG Dandan,YU Hui.Discussion on the Rationality of Sampling Rules for Pharmaceutical Packaging Based on National Standards[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(10):1482-1484. |
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| 摘要: |
| 目的 探讨药包材抽样过程中存在的问题，为科学合理的药包材抽样规则提供统一的方案，保证药包材检验的准确性和可操作性。方法 通过对药包材国家标准的检验项目分析梳理，对药包材抽样规则提出解决问题的措施和办法。结果 建立统一的药包材抽样规则，规范药包材抽样过程中的方式和数量，对药包材抽样人员具有指导作用。结论 只有合理的抽样规则，才能确保检验数据的准确性。 |
| 关键词: 国家标准 药包材 抽样规则 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.10.028 |
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| Discussion on the Rationality of Sampling Rules for Pharmaceutical Packaging Based on National Standards |
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CHEN Chao, ZI Xiaowei, JIN Li, WANG Dandan, YU Hui
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Zhejiang Insititute for Food and Drug Control, Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Provincial, Hangzhou 310051, China
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| Abstract: |
| OBJECTIVE To discuss the problems existing in the sampling process of the pharmaceutical packaging. A unified scheme was provided for the scientific and reasonable sampling rules of the pharmaceutical packaging, so as to ensure the accuracy and operability of the inspection of the pharmaceutical packaging. METHODS By means of pectination the inspection item of national standards, propose the measures and methods to solve the problem of sampling rule of pharmaceutical packaging. RESULTS To establish a uniform sampling rule of pharmaceutical packaging and to standardize the modes and quantities in the sampling process of pharmaceutical packaging, could guide the sampling personnel. CONCLUSION The accuracy of inspection data can only be ensured on the basis of reasonable sampling rules. |
| Key words: national standard pharmaceutical packaging sampling rule |
