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DEHP和TOTM增塑的PVC一次性输液器与脂肪乳注射液药物相容性研究

Drug compatibility between fat emulsion injection and PVC disposable infusion set plasticized with DEHP and TOTM

作者: 魏嫣  黄元礼  王丽  马立群  艾鸣哲 
单位:国家食品药品监督管理局湖北医疗器械质量监督检验中心(武汉430075)
关键词: 邻苯二甲酸二乙基乙酯;偏苯三酸三辛酯;增塑剂;脂肪乳;药物相容性 
分类号:R318.04
出版年·卷·期(页码):2016·35·1(41-45)
摘要:

目的 通过研究含有邻苯二甲酸二乙基乙酯(diethylhexyl phthalate, DEHP)和偏苯三酸三辛酯(trioctyl trimellitate, TOTM)两种增塑剂的一次性输液器与脂肪乳注射液的药物相容性,考察新型增塑剂TOTM对脂肪乳注射液的安全性。对DEHP和TOTM增塑的PVC输液器的风险评估提出可行性依据。方法 模拟临床使用条件,收集不同时间点经过输液器的脂肪乳注射液,采用HPLC进行测试,考察两种输液器对于脂肪乳注射液中大豆油的吸附性能及增塑剂的迁移情况。建立了同时检测脂肪乳注射液中DEHP和TOTM的高效液相色谱方法。结果 脂肪乳中的大豆油在两种管路中吸附情况不同,两种输液器对大豆油均有一定的吸附作用,DEHP为增塑剂的输液器在模拟使用4h内大豆油浓度变化率为87.5%~92.0%。TOTM为增塑剂的输液器对大豆油吸附随使用时间的延长吸附渐大,在使用的前2h几乎无吸附,大豆油浓度相对于零时间的变化率为98.4%~99.6%;在使用2h后开始有明显吸附,大豆油浓度相对于零时间的变化率达47.9%~52.0%。增塑剂迁移试验中,在本实验的检出限条件下,未检出DEHP的迁移,TOTM的迁移在脂肪乳流经输液器30~60min过程中有检出。结论 本方法考察了TOTM和DEHP为增塑剂的PVC一次性输液器与脂肪乳注射液的药物相容性,为风险评估提供依据。

Objective To evaluate the safety of TOTM, this study carried on the research on the drug compatibility between fat emulsion injection and PVC disposable infusion set plasticized with DEHP and TOTM, and provided acceptable support for safety evaluation of PVC infusion apparatus of different plasticizers. Methods After simulating clinical conditions, collecting the fat emulsion injection runs by the PVC disposable infusion set at different time point, and adopting HPLC to test, the adsorption properties of soybean oil and plasticizer migration was inspected between the two infusions. We established a HPLC approach to detect the content of both DEHP and TOTM in the fat emulsion injection. Results The soybean oil in fat emulsion injection was absorbed differently in the two tubes. The rate of change of the soybean oil concentration within 4 h is 87.5% to 92.0% in the infusion which was used DEHP as plasticizer. The absorption of the infusion to soybean oil which was used TOTM as plasticizer increased with the time. Relative to zero time concentration, the rate of change of the soybean oil concentration in the infusion which was used TOTM as plasticizer reached 98.4% to 99.6% in the first two hours, almost no absorption. After two hours, the rate of change of the soybean oil concentration reached 47.9% to 52.0% compared to the concentration of zero time. Obvious absorption of soybean oil began after 2h since TOTM was used. In plasticizer migration test the migration of DEHP was not detected while the migration of TOTM was detected when fat emulsion injection flew through the infusion from 30min to 60min. Conclusions This method evaluates the two plasticizers, TOTM and DEHP, on its drug compatibility of PVC disposable infusion set and fat emulsion injection.

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