| 王林波,陈祝康,李明程,吴静雯,夏慧敏,彭兴盛,陈桂良.质量控制图在药物非那西汀熔点测定中的应用研究[J].中国药事,2018,32(2):225-233 |
| 质量控制图在药物非那西汀熔点测定中的应用研究 |
| On the Application of Shewhart Control Chart in Determining the Melting Point of Phenacetin |
| 修订日期：2017-07-20 |
| DOI：10.16153/j.1002-7777.2018.02.012 |
| 中文关键词: 药物检测 熔点 非那西汀 质量控制图 药品检验质量管理 |
| 英文关键词: drug testing melting point phenacetin Shewhart control chart quality management of drug control |
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| 中文摘要: |
| 目的：建立熔点测定质量控制图，对药物原料熔点测定进行日常监控。方法：查阅相关标准、规范以及文献，以非那西汀熔点测定为例，建立质量控制图，提出建立质量控制图的工作流程。结果与结论：药物熔点检测质量控制图的制作工作流程主要包括：熔点控制样的制备和评估、子组数据正态性检验、预控制图的制作、控制图的建立和应用以及控制图的修订等步骤。质量控制图可以直观地反映出检测的过程状态，对于药品检测实验室宏观、长期的质量控制有重要意义。 |
| 英文摘要: |
| Objective: To establish a Shewhart control chart for daily monitoring the melting point of drug raw material. Methods: Revelant standards, regulations and literature were reviewed. The Shewhart control chart was established and the corresponding workflow was proposed by using phenacetin melting point test as an example. Results and Conclusion: The workflow of the established Shewhart control chart in determining the melting point of drugs mainly includes the following steps:preparation and evaluation of the melting point control samples, normality test of subgroup data, preparation of pre-control charts, establishment and application of the control charts, as well as the revision of control charts. The Shewhart control chart can directly demonstrate the status of testing process and is important for the overall and long-term quality control of drug testing laboratories. |
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