新生儿肠外营养液稳定性及质量控制研究

Study on stability and quality control of neonatal parenteral nutrition

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 stability and quality control of neonatal parenteral nutrition. METHODS The neo- natal parenteral nutrition was mixed and respectively placed at 4, 20, 40 ℃, and investigated by the changes of appearance, as- say of Sudan dyes, pH value, insoluble particles, particle size and distribution, and sterile test and bacterial endotoxin test. RESULTS The nutrition placed at 4,20 ℃ had not changed significantly for appearance, pH value, average particle size and PDI value, and the sterility test and bacterial endotoxin test met the quality requirements. However, the average particle size and PDI value of nutrition placed at 40℃ became more and more bigger. CONCLUSION The neonatal parenteral nutrition placed at 4, 20 ℃ has good stability. In order to ensure the quality of nutrition, some suggestions for effective quality control should put into practice on a regular basis.