| 刘桂花,苏美,崔效庭,张中湖.药品追溯体系融合快检技术的探索[J].中国药事,2020,34(8):865-871 |
| 药品追溯体系融合快检技术的探索 |
| Exploration on the Integration of Drug Traceability System and Rapid Detection Technology |
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| DOI：10.16153/j.1002-7777.2020.08.002 |
| 中文关键词: 药品追溯体系 RACOFIC系统 拉曼光谱 特征峰 |
| 英文关键词: drug traceability system RACOFIC system raman spectrum characteristic peak |
| 基金项目:国家重大科学仪器专项“便携式薄层色谱-拉曼光谱联用仪及其药品快检支撑系统(编号 2012YQ180132)”；山东省重点研发计划“RACOFIC系统在药品追溯体系建立中的基础及应用研究(编号 2017GSF20106)” |
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| 中文摘要: |
| 目的：为药品追溯体系融入检验技术，强化药品追溯体系“防止假药、劣药进入合法销售渠道” 功能。方法：应用定制拉曼光谱仪采集原料、辅料、药品制剂光谱信息，实现光谱信息在拉曼光谱-化药快检支撑系统(RACOFIC)和药品追溯系统中的数据共享。结果：RACOFIC系统与药品追溯系统的对接，能够杜绝“监管码、批号均正确，但是药品已掉包”的现象发生。结论：基于拉曼光谱技术和现代化信息技术，药品追溯体系融合快检技术具有可行性和必要性。 |
| 英文摘要: |
| Objective: Integrating testing technology into the drug traceability system and strengthen its function of "preventing counterfeit and substandard drugs from entering legal channels". Method: Spectral information of raw materials, auxiliary materials and pharmaceutical preparations were collected by the customized Raman spectrometer to achieve data sharing of spectral information in RACOFIC system and drug traceability system. Result: The docking of RACOFIC system and drug traceability system could prevent the phenomenon of "the supervision code and batch number being correct, while the drug having been replaced". Conclusion: Based on Raman spectroscopy and modern information technology, it is feasible and necessary to integrate rapid detection technology into drug traceability system. |
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