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目的:考察新生儿肠外营养液稳定性及质量控制研究。方法:将营养液分别于4,20,40℃下放置,分别于0,12,24 h考察其外观变化、用苏丹红染料检测、测定其p H值、不溶性微粒数、乳粒粒径大小及粒度分布,并进行无菌试验和细菌内毒素检查。结果:于4,20℃下放置的营养液的外观、p H值、平均粒径和PDI值均变化不大,无菌试验和细菌内毒素检查均符合质量要求,但40℃下放置的营养液的平均粒径和PDI值均变大。结论:4,20℃下放置的新生儿肠外营养的稳定性较好。为保证营养液的质量,建议定期进行有效的质量监控。
Objective: To investigate the stability and quality control of neonatal parenteral nutrition solution. Methods: The nutrient solution was placed at 4, 20 and 40 ℃, respectively. The changes of appearance were observed at 0, 12 and 24 h, respectively. The p H value, the number of insoluble particles and the size of the milk grains And particle size distribution, and sterile test and bacterial endotoxin test. Results: The appearance, p H value, average particle diameter and PDI value of nutrient solution placed at 4 and 20 ℃ showed little change. Sterility test and bacterial endotoxin test all met the quality requirements. However, the nutrition The average particle size and PDI of the liquid became larger. Conclusion: The stability of neonatal parenteral nutrition placed at 4 ℃ is better. In order to ensure the quality of nutrient solution, it is recommended to carry out effective quality control on a regular basis.