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在线溶解氧和气相氧分析监测技术在注射剂中的应用

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在注射剂生产过程中应用在线溶解氧测量系统和气相氧分析测量系统,可降低药液中的游离氧和残氧值.在实际生产中,在注射剂的配制与灌封工序上安装在线溶解氧测量系统与气相氧分析测量系统,进行在线监控和数据收集,其过程监控有效、产品质量稳定.通过在线溶解氧和气相氧分析测量系统的监控,药液中的溶解氧含量可以控制在500 μg/L以下,瓶中残氧可以控制在2%以下,可有效降低注射剂产品中的氧含量,解决因氧化分解导致产品变色和有关物质超标的问题,从而提升产品质量.
Application of Online Dissolved Oxygen and Gas Phase Oxygen Analysis Monitoring Technology in Injection
The online dissolved oxygen measurement system and the gas phase oxygen analysis measurement system can reduce the free oxygen and residual oxygen of physic liquor during the injection production process.In the actual production,the online dissolved oxygen measurement system and gas phase oxygen analysis measurement system are installed in the injection preparation and potting process to carry out online monitoring and data collection,and the process monitoring is effective and the product quality is stable.Through the monitoring of the online dissolved oxygen and gas phase oxygen analysis measurement system,the dissolved oxygen content in the physic liquor can be controlled below 500 μg/L,and the residual oxygen in the bottle can be controlled below 2%,which can effectively reduce the oxygen content in the injection products,solve the problem of product discoloration and related substances exceeded due to oxidation decomposition,so as to improve product quality.

dissolved oxygengas phase oxygenresidual oxygen

杜英硕、丛金丽、温芳、张彬

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华润双鹤药业股份有限公司,北京 100121

溶解氧 气相氧 残氧

2024

化工管理
中国化工企业管理协会

化工管理

影响因子:0.336
ISSN:1008-4800
年,卷(期):2024.(18)