一次性避光输液器避光性能的研究

Light-resistance Performance of Disposable Light-Resistance Infusion Sets

研究影响一次性使用避光输液器避光性能的因素,确定影响产品避光性能的主要技术参数,保证避光输液器产品的质量。采用双层共挤(吹)塑工艺,加入避光剂的管路/滴斗外层不接触药液,接触药液的管路/滴斗内层不含避光剂,规避避光剂与药物的接触反应和药物的遇光分解,影响疗效;保持避光剂占成型基料聚氯乙烯的质量分数(简称避光剂浓度)不变,调节避光层(管路/滴斗外层)厚度,检测管路/滴斗的透光率,确定避光层的合理厚度;保持避光层厚度不变,调节避光剂浓度,检测管路/滴斗的透光率,确定合理的避光剂浓度;综合比较,确定避光输液器合理的主要技术参数及产品避光性能。避光剂浓度保持不变,管路/滴斗透光率与避光层厚度成反比,当避光剂浓度为0.20%,避光层厚度≥0.40mm,管路/滴斗透光率符合标准要求;避光层厚度保持不变,管路/滴斗透光率与避光剂浓度成反比,当避光层厚度为0.45 mm,避光剂比例在0.20%,避光率符合标准要求。一次性使用避光输液器采用双层共挤(吹)塑工艺生产,避光剂浓度控制在0.20%,输液管路/滴斗避光层厚度控制在(0.45±0.05)mm,管路内层控制在(0.20±0.05)mm,避光输液器产品的性能符合技术要求。

To investigate the factors that affect the light-resistance performance of disposable lightresistance infusion sets,and to determine the involved key technical parameters,and to ensure the quality of the products.Adopting a double-layer co-extrusion(blow molding)process,the outer layer of the transfusion tubes/drip buckets with added opaquing agents does not come into contact with the medicine,while the inner layer of the transfusion tubes/drip buckets that comes into contact with the medicine does not contain opaquing agents,avoiding both contact reaction between the opaquing agents and the medicine and the photodegradation of the medicine,which affects the therapeutic effect;Maintain the mass fraction(referred to as the concentration)of the opaquing agents in the formed PVC base material unchanged,adjust the thickness of the light-resistance layer(outer layer of the transfusion tubes/drip buckets),test the transmittance of the transfusion tubes/drip buckets,and determine the reasonable thickness of the light-resistance layer;Maintain the thickness of the light-resistance layer unchanged,adjust the concentration of the opaquing agent,test the transmttance of the transfusion tubes/drip buckets,and determine a reasonable concentration of the opaquing agents;By comprehensive comparison,determine both the reasonable main technical parameters and the light-resistance performance of the products.The concentration of the opaquing agents remains unchanged,and the transmittance of the transfusion tubes/drip buckets is inversely proportional to the thickness of the light-resistance layer.When the concentration of the opaquing agents is 0.20%and the thickness of the light-resistance layer is≥0.40 mm,the transmittance of the transfusion tubes/drip buckets meets the standard requirements.The thickness of the light-resistance layer remains unchanged,and the transmittance of the transfusion tubes/drip buckets is inversely proportional to the concentration of the lightresistance agents.When the thickness of the light-resistance layer is O.45 mm and the proportion of the opaquing agent is≥0.20%,the light-resistance rate meets the standard requirements.The disposable light-resistance infusion sets are produced using a double-layer co extrusion(blow molding)process,with a concentration of anti light agent controlled at 0.20%.The thickness of the light-resistance layer of the transfusion tubes/drip buckets is controlled at(0.45±0.05)mm,and the inner layer of the pipeline is controlled at(0.20±0.05)mm.The performance of the light-resistance infusion sets meets the technical requirements.