首页|输液包装用二氧化碳指示剂使用性能的分析

输液包装用二氧化碳指示剂使用性能的分析

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目的 探究二氧化碳指示剂在不同环境温度下以及不同二氧化碳浓度中的灵敏度。方法 通过改变二氧化碳指示剂所处环境的温度、浓度,综合评价二氧化碳指示剂的变色情况,为药品的安全性做出指导。结果 通过检测二氧化碳指示剂在不同温度下的变色速度、在不同浓度二氧化碳环境中的显色情况以及在不同恶劣条件下的响应值,运用数学分析软件模拟二氧化碳浓度、温度、考察时间与二氧化碳指示剂颜色之间的函数关系。利用这种关系,依据二氧化碳指示剂的颜色状态,推断出实际生产过程中高阻隔外袋内的二氧化碳浓度范围以及高阻隔外袋的密封性情况。结论 通过指示剂的颜色不仅可以判断外阻隔袋的密封性是否完整,还可以指导药品生产过程和使用过程的安全性,有利于产品生产质量安全的保证。
Study on the performance of carbon dioxide indicator used in infusion packaging
Objective To explore the sensitivity of carbon dioxide indicators at different environmental,temperatures and carbon dioxide concentrations.Methods By changing the temperature and concentration of the environment where the carbon dioxide indicator is located,comprehensively evaluate the discoloration of the carbon dioxide indicator,and provide guidance for the safety of drugs.Results By measuring the speed of discoloration at different temperatures,the color development in different carbon dioxide environment and the response values under different harsh conditions,the mathematical analysis software was used to simulate the functional relationship between carbon dioxide concentration,temperature,inspection time and the color of carbon dioxide indicator.Based on the relationship,the range of carbon dioxide concentration inside the high barrier outer bag and the sealing condition of the high barrier outer bag in the actual production process can be inferred,according to the color status of the carbon dioxide indicator.Conclusion The color of the indicator not only determines the sealing integrity of the outer barrier bag,but also guides the safety of drugs during production and usage process,which is conducive to ensuring the quality and safety of product production.

Carbon dioxide indicatorsTemperatureConcentrationLeak hole

张飞龙、王浩源、袁梦莹

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山东齐都药业有限公司,山东 淄博 255400

二氧化碳指示剂 温度 浓度 泄漏孔径

2024

药学研究
山东省药品检验所 山东省药学会

药学研究

CSTPCD
影响因子:0.653
ISSN:2095-5375
年,卷(期):2024.43(7)