一次性使用体腔热灌注治疗管道组件(BR-TRG-V型)的药物相容性和邻苯二甲酸二(2-乙基)己酯(DEHP)溶出量测定研究

Research on the Drug Compatibility of the Disposable Body Cavity Hyperthermia Treatment Tubing Components(BR-TRG-V Type)and the Dissolution of Bis(2-Ethylhexyl)Phthalate(DEHP)

目的:通过对一次性使用体腔热灌注治疗管道组件(BR-TRG-V型)与不同类型药物的相容和邻苯二甲酸二(2-乙基)己酯(DEHP)溶出试验研究,为BR-TRG-V型管道的临床应用提供安全性依据。方法:试验选取三种化疗药物(紫杉醇、奥沙利铂、氟尿嘧啶),通过模拟临床使用的条件,检测上述药液流经BR-TRG-V型管道后药物含量、pH值、有关物质、不溶性微粒、澄清度和颜色变化以及DEHP溶出情况。结果:三种药物通过BR-TRG-V型管道后,其药物含量、pH值、有关物质、不溶性微粒、澄清度和颜色变化无统计学差异(P>0.05)。紫杉醇和乙醇溶液作为浸提介质DEHP溶出量分别为(1.83±0.06)μg/mL、(6.10±0.30)μg/mL;奥沙利铂、氟尿嘧啶、盐酸和氢氧化钠溶液未检测出。结论:BR-TRG-V型管道的药物相容性良好,DEHP在紫杉醇和乙醇溶液中有少量溶出,但都在安全范围内,临床应用是安全的。

Objective:We studied the compatibility of the disposable body cavity thermo-perfusion therapy tubing components(BR-TRG-V type)with different types of drugs and the dissolution of bis(2-ethylhexyl)phthalate(DEHP),and then provide a safety basis for the clinical application of the BR-TRG-V pipeline.Methods:We selected three chemotherapeutic drugs(paclitaxel,oxaliplatin,fluorouracil)and detected the drug content,pH value,related substances,insoluble particles,clarity and color change,the dissolution of DEHP after the drug solution flows through the BR-TRG-V pipeline.Results:There was no statistical difference in the drug content,pH value,related substances,insoluble particles,clarity and color changes(P>0.05).When paclitaxel and ethanol solution were used as the extraction medium,the dissolution rate of DEHP was(1.83±0.06)μg/mL and(6.10±0.30)μg/mL.We did not detected DEHP in oxaliplatin,fluorouracil,hydrochloric acid and sodium hydroxide solution.Conclusion:The BR-TRG-V type pipeline has good drug compatibility.DEHP has a small amount of dissolution in paclitaxel and ethanol solution,but they are all within the safe range,and clinical application is safe.