PVC材质一次性输注泵在常用局麻药应用中的安全性研究

Safety Assessment of Disposable Infusion Pump Made up of PVC Used for Anesthesia Drugs

关键词:  一次性使用输注泵  局麻药物  邻苯二甲酸二-( 2-乙基己基)酯  不溶性微粒  药物吸附性  高效液相色谱-质谱法

Key words:  the disposable infusion pump  local anesthesia drugs  di(2-ethylhexyl)phthalate(DEHP)  insoluble particle  drug adsorption  LC-MS/MS

摘要:

目的 考察一次性使用输注泵与常用局麻药的相容性，评定其在临床常用局麻药物使用中的安全性。方法 3种常用局麻药分别与2种液体(生理盐水及乳酸林格氏液)按临床使用浓度配伍，在不同时间点分别采用LC-MS/MS法、光阻法、高效液相色谱法测定邻苯二甲酸二-(2-乙基己基)酯(DEHP)含量、不溶性微粒和药物浓度。结果 DEHP含量低于LC-MS/MS测定方法定量下限(0.072 μg·mL^-1)，更低于考核标准静脉晶体溶液输注成年人(70 kg)DEHP剂量上界估算值(0.005 mg·kg^-1·d^-1)；48 h内各实验药物在一次性使用输注泵中药物含量相对0 h均>96.0%，受试输注泵与各种药物在48 h内未见明显吸附；输注泵中溶液稳定，0 h每1 mL粒子直径≥10 μm粒子数(n=30)(35.13±14.4)粒；每1 mL粒子直径≥25 μm粒子数(n=30)(0.61±0.49)粒，符合中国药典2010版标准。结论 研究表明本一次性使用输注泵应用于3种常用局麻药物较为稳定，其DEHP溶出、不溶性微粒及药物吸附性等方面符合安全使用要求。

Abstract:

OBJECTIVE To investigate the compatibility of the disposable infusion pump with the local anesthesia drugs and provide reference for its safety. METHODS DEHP, insoluble particle and drug concentration at different time when three anesthesia drugs(bupivacaine hydrochloride injection/ropivacaine mesylate injection/tramadol hydrochloride injection) dissolves in NS and lactated ringer’s solution were tested by LC-MS/MS, light obscuration particle count test, HPLC. RESULTS The dissolving amount of DEHP was lower than the quantitation limit of LC-MS/MS and also far beyond assessment standard intravenous infusion of adults. The drug content in the disposable infusion pump was greater than 96.0% at 48 h compared with 0 h. All kinds of drugs had no obvious adsorption within 48 h. For the insoluble particle, diameter greater than 10 micron was 35.13±14.4 within 1 mL solution; diameter greater than 25 micron was 0.61±0.49 within 1mL solution. CONCLUSION It is safety for disposable infusion pump used in clinical with anesthesia drugs.