混合糖电解质在全肠外营养液中的稳定性评价

Evaluation on the stability of carbohydrate-electrolyte in the total parenteral nutrient solutions

目的:考察混合糖电解质在全肠外营养液中的稳定性。方法:按照"全合一"(AIO)营养液处方和配制原则,分别采用混和糖电解质注射液(混合糖组)和10%葡萄糖注射液(葡萄糖组)作为能量补充剂配制全肠外营养液,室温下观察和测定2组营养液0～72h外观、pH、渗透压、电解质、不溶性微粒和脂肪乳滴聚集情况,比较2组间差异并进行稳定性评价。结果:混合糖组和葡萄糖组的pH和渗透压分别波动于5.69～5.82,737～768mOsmol.kg-1和5.95～6.00,692～704mOsmol.kg-1。混合糖组中Ca2+、Mg2+的浓度明显高于葡萄糖组。2组pH值、渗透压、电解质浓度72h内基本稳定。混和糖组10h内和葡萄糖组24h内粒度分布均匀,均无粒径>10μm的颗粒出现。混合糖组营养液随放置时间延长脂肪乳滴发生聚集,24h出现粒径>10μm的颗粒。结论:混合糖电解质配制的肠外营养液在10h内pH、渗透压、电解质浓度均未发生明显变化,不溶性微粒及脂肪乳滴粒径分布和大小符合药典要求,可以推荐选用混合糖电解质作为全营养混合液中非蛋白能量补充剂使用;但因混和糖电解质中二价电解质对营养液稳定性有一定影响,故应注意其用量,配制后应在10h内输注完毕。

OBJECTIVE To investigate the stability of carbohydrate-electrolyte as energy replenisher used in the total paren- teral nutrient solutions. METHODS All-in-one admixtures were prepared separately with carbohydrate-electrolyte injection and 10% glucose injection according to the same formula and dispensing principle in clean area. The physical and chemical properties, for example, the appearances, pH values, osmolality, concentration of electrolytes, the change of microparticle-size dis- tribution and the accumulation of fat emulsion drops of two kinds of admixture systems stored in EVA bags at room tempera- ture for 72 h were observed and measured. At the same time, the differences were compared and the stabilities were evaluated between two admixture solutions. RESULTS The pH values and the osmolality of carbohydrate-electrolyte system and 10% glucose system were between 5.69-5.82, 737-768 mOsmol·kg-1 and 5.95-6. 06, 692-704mOsmol·kg-1 respectively. The con- centrations of Ca2. , Mg2＋ of carbohydrate-electrolyte system were larger than 10% glucose system. The pH value, osmolali- ty, electrolyte were stable in 72 h. The particle size of carbohydrate-electrolyte system in 10 h and which of 10% glucose sys- tem in 24 h were well-distributed, and no particles were larger than 10 fire. The fat emulsion drops were assembled and the particles with a size larger than 10μm appeared. CONCLUSION The carbohydrate-electrolyte could be recommended as non- protein energy replenisher in total nutrient admixture. Furthermore, once prepared, the solutions should be infused as soon as possible and the storage of which should not beyond 10 h.