注射用泮托拉唑钠与8种常用注射剂的配伍稳定性考察

Compatibility of pantoprazole sodium for injection combined with eight common injections

目的:考察室温条件下注射用泮托唑钠与8种临床常用药物的配伍稳定性。方法:建立了泮托拉唑钠高效液相含量测定方法,模拟临床应用,以0.9%的氯化钠溶液为溶媒,按比例分别将注射用泮托拉唑钠与肌苷注射液、维生素B6注射液、维生素K_1注射液、注射用辅酶A、氨苯甲酸注射液、酚磺乙胺注射液、门冬氨酸钾镁注射液、注射用ATP8种临床常见药物混合,在混合后即刻、0.5,1,2 h 4个时间点考察泮托拉唑含量、外观、不溶性微粒、溶液pH值的变化。结果:泮托拉唑钠与氨苯甲酸、酚磺乙胺、维生素B6配伍后2 h内含量明显下降。结论:泮托拉唑对pH敏感,注射用泮托拉唑钠不宜与氨苯甲酸、酚磺乙胺、维生素B6配伍,序贯使用时需冲洗管路。

OBJECTIVE To investigate the compatibility of pantoprazole combined with eight commonly administered injectables under ambient room temperature.METHODS The HPLC method for pantoprazole determination was established.Simulated Y-site compatibility evaluation was accomplished by mixing pantoprazole with an alternative intravenous medication（inosine injection,vitamin B_6 injection,vitamin K_1 injection,coenzyme A for injection,aminomethylbenzoic acid injection,ethamsylate injection,potassium magnesium aspartate injection and adenosine disodium triphosphate injection）in NS,and then the mixture was stored in a polypropylene syringe for 2 h.The concentration of pantoprazole,appearance,the number of insoluble particles and pH value of pantoprazole in admixtures were observed immediately and at 0.5,1 and 2 h.RESULTS The content of pantoprazole declined obviously in two hours after mixing with aminomethylbenzoic acid injection,etamsylate and vitamin B_6 injection,respectively.CONCLUSION The pantoprazole injection is sensitive to pH value,and should not be administered concomitantly with aminomethylbenzoic acid injection,etamsylate or vitamin B_6 injection.Furthermore,the pipeline should be cleaned when pantoprazole is sequential Y-site administered with any one of these products.