全胃肠外营养液的稳定性考察

目的：考察全胃肠外营养液（TPN）组方的稳定性,为临床使用提供参考,并希望能引起各环节（生产、复配使用、贮存）对药品稳定性的重视.方法：选择临床常用科室的10份TPN液处方,包括外科、内科系统,在本院静脉用药配置中心的净化环境下,按TPN液标准操作规程配制后,在常温下,采用外观观察法、pH检测法、不溶性微粒检查法考察TPN液在0,4,8,12,16,20,24,30 h各时间点外观、pH、微粒的变化,并进行无菌考察.结果：10份TPN液在各时间点,外观未见明显变化,10组TPN液的pH在不同时间点比较,差异均无统计学意义（P＞0.05）,但不同组TPN液的pH差异有统计学意义（P＜0.05）;TPN配伍后随着放置时间的延长,微粒直径≥10 μm和≥25 μm的微粒数都有所增加,不同组TPN液的微粒数比较,差异无统计学意义（P＞0.05）;配制后无菌考察均合格.结论：建议TPN液在净化环境下配置,其pH在5～6范围内稳定性最好,TPN配制后不溶性微粒会随着放置时间的延长而明显增多,需引起临床注意并及早输注,以保证临床应用安全、合理、有效.

Stability of Total Parenteral Nutrition Solutions

Objective：To observe the stability of total parenteral nutrition （TPN） solutions to provide reference for clinical use and cause stability attention in each link （production,combination use and storage）.Methods：According to the standardized operation procedure of TPN solutions,10 samples of TPN solutions were prepared in PIVAS.The appearance,pH and insoluble particles were observed at the different time intervals （0,4,8,12,16,20,24 and 30h）,and the aseptic examination was carried out as well.Results：The appearance and pH were both stable at different time intervals,there was no statistic difference among different time intervals of pH （P ＞ 0.05）,but there was significant statistic difference among different groups （P ＜ 0.05） ; the numbers of insoluble particules of different diameters were obviously increased,but there was no statistic difference among different groups （P ＞ 0.05） ; septic examination of all groups were qualified.Conclusion：TPN solutions should be prepared in purified environment.The stability of the solutions is the most stable when pH of the solutions is within the range of 5-6.The insoluble particles in the solutions are increased by the time,so they should be infused as early as possible to guarantee the safety,rationality and effectiveness of the products.