不同生产厂家中/长链脂肪乳注射液在全肠外营养液中的稳定性和相容性研究

Study on the stability and compatibility of different medium/long-chain fat emulsion injections in total parenteral nutrition solution

目的:研究不同生产厂家中/长链脂肪乳注射液在全肠外营养液(total parenteral nutrition,TNA)中的稳定性和相容性,为临床使用提供参考。方法:按照相同的调配方法,分别将3种不同生产厂家中/长链脂肪乳注射液(C8~24)加在相同配方TNA中,在室温(25℃)下,分别考察0,1,2,4,12,24,48,72 h各时间点溶液外观、pH值、渗透压、乳粒粒径大小、不溶性微粒、Zeta电位及无菌等变化情况。结果:观察溶液外观均无油滴析出、聚集、分层等破乳现象;渗透压、乳粒粒径大小、无菌结果等均无明显差异(P<0.05);pH值在放置0~24 h差异无统计学意义(P>0.05),48~72 h有显著性差异(P<0.05);Zeta电位均有显著性差异(P<0.05);TNA配制后随着放置时间的延长,微粒直径≥10μm和≥25μm的微粒数都有所增加,放置0~48 h差异无统计学意义(P>0.05);配制后无菌考察均合格。结论:3所不同生产厂家中/长链脂肪乳注射液在TNA中稳定性、相容性无较大差异,24 h内均符合《中国药典》对静脉用乳状液型注射液标准要求,故建议24 h内完成输液。

OBJECTIVE To investigate the stability and compatibility of medium/long-chain fat emulsion injections from different manufacturers in total parenteral nutrition solution(TNA),and to provide a reference for the clinical application.METHODS According to the same preparation method,medium/long chain fat emulsion injection(C8-24)from three different manufacturers was added into the same formula of TNA,and the changes of appearance,pH value,osmotic pressure,emulsion particle size,insoluble particles,zeta potential and sterility of the solution at each time point of 0,1,2,4,12,24,48 and 72 hours were investigated at room temperature(25℃).RESULTS There was no emulsion breaking phenomenon such as oil droplet precipitation,aggregation and stratification in the appearance of the solution observed;there was no significant difference in osmotic pressure,emulsion particle size and sterility results(P<0.05);there was no significant difference in pH value between 0-24 h(P>0.05),but there was significant difference between 48-72 h(P<0.05);there was significant difference in zeta potential(P<0.05);with the extension of storage time after TNA compatibility,the number of particles with particle diameter≥10μm and≥25μm increased,but there was no significant difference between 0-48 h(P>0.05);the sterility test after preparation was qualified.CONCLUSIONS There is no significant difference in the stability and compatibility of medium/long chain fat emulsion injection among the three different manufacturers in TNA,and all of them meet the standard requirements for intravenous emulsion injection in Chinese Pharmacopoeia within 24 hours,so it is recommended to complete the infusion within 24 hours.