脂肪乳氨基酸(17)葡萄糖(11%)注射液稳定性研究  

Stability Study of Fat Emulsion,Amino Acids(17)and Glucose(11%)Injection

作　　者：杨培培[1] 张丽雯 程钢[1] 黄赵刚[1] YANG Peipei;ZHANG Liwen;CHENG Gang;HUANG Zhaogang(Department of Pharmacy,The First Affiliated Hospital of Anhui Medical University·The Grade 3 Pharmaceutical Chemistry Laboratory of National Administration of Traditional Chinese Medicine,Hefei,Anhui,China 230022)

机构地区：[1]安徽医科大学第一附属医院药剂科·国家中医药管理局中药化学三级实验室,安徽合肥230022

出　　处：《中国药业》2024年第2期60-62,共3页China Pharmaceuticals

摘　　要：目的为临床合理使用脂肪乳氨基酸(17)葡萄糖(11%)注射液(商品名卡文)提供依据。方法将卡文3个腔室液体混匀(样品S1);再分别添加电解质(氯化钾和氯化钠,样品S2),维生素(水溶性维生素及脂溶性维生素,样品S3),多种微量元素(样品S4),以及上述所有成分(样品S5)。分别于室温下放置0,4,8,12 h时测定混合液的pH、渗透压、不溶性微粒数,并考察乳剂粒径分布情况。结果样品S1-S5室温下放置12 h内外观无明显变化,pH为5.51~5.59;渗透压,S2为934~972 mOsmol/kg,S3为816~831 mOsmol/kg,S4为810~835 mOsmol/kg,S5为934~957 mOsmol/kg;不溶性微粒变化不明显;乳剂粒径分布集中在1~10 nm。结论在卡文中添加规定限度内的电解质、维生素和多种微量元素,对其pH、不溶性微粒、乳剂粒径等影响较小,但电解质对渗透压影响较大,应予以重视。Objective To provide a basis for the rational use of Fat Emulsion,Amino Acids(17)and Glucose(11%)Injection(trade name:Kabiven PI)in clinical practice.Methods The liquid in three chambers of Kabiven PI was mixed evenly(sample S1)and added electrolytes(potassium chloride and sodium chloride,sample S2),vitamins(water-soluble vitamins and fat-soluble vitamins,sample S3),multiple trace elements(sample S4)and all the above components(sample S5)separately.The above samples were placed at room temperature for 0,4,8 and 12 h,the pH,osmotic pressure,number of insoluble particles of the mixture were determined,and the particle size of the emulsion was explored.Results There was no significant change in the appearance of the samples S1-S5 after being placed at room temperature for 12 h,and the pH was in the range of 5.51 to 5.59.The osmotic pressure of samples S2-S5 was in the range of 934 to 972 mOsmol/kg,816 to 831 mOsmol/kg,810 to 835 mOsmol/kg,934 to 957 mOsmol/kg respectively.The change in the number of insoluble particles of the mixture was not obvious within 12 h.The particle size of the emulsion was in the range of 1 to 10 nm.Conclusion The addition of electrolytes,vitamins and multiple trace elements within the specified limits in the Kabiven PI has a little effect on the pH,insoluble particles and particle size of emulsion.However,the addition of electrolytes has a great effect on the osmotic pressure,which should be paid attention.

关 键 词：脂肪乳氨基酸(17)葡萄糖(11%)注射液 电解质 维生素 配伍 稳定性 

分 类 号：R917[医药卫生—药物分析学]