不同浓度K^+对肠外营养液稳定性的影响研究  

Study on the Effects of Different Concentrations of K+on the Stability of Total Parenteral Nutrition

作　　者：杜珮瑜 郑雪花[1] 李晓冰[1] 高宇 接丽莉 杨跃辉[1] DU Peiyu;ZHENG Xuehua;LI Xiaobing;GAO Yu;JIE Lili;YANG Yuehui(Dept.of Pharmacy,Shengjing Hospital of China Medical University,Shenyang 110004,China;College of Pharmacy,China Medical University,Shenyang 110122,China)

机构地区：[1]中国医科大学附属盛京医院药学部,沈阳110004 [2]中国医科大学药学院,沈阳110122

出　　处：《中国药房》2018年第15期2037-2040,共4页China Pharmacy

基　　金：国家自然科学基金青年科学基金项目(No.81503169)

摘　　要：目的:考察不同浓度K^+对肠外营养液(TPN)稳定性的影响,为临床合理用药提供参考。方法:分别设计含不同浓度(29.13、43.23、50.16、57.02、70.53、83.75 mmol/L,分别为组1~组6)K^+的TPN处方,按照无菌操作规程制备静脉营养输液袋后,考察其在室温(25℃)下分别放置0、8、24、48 h后的外观、p H值、不溶性微粒、脂肪乳粒径和粒度(以多分散系数表示)分布,考察不同浓度K^+对TPN稳定性的影响。结果:6组TPN在放置0、8、24、48 h后肉眼观察其外观均无颜色变化,均无分层、絮凝、挂壁等现象;在室温下放置48 h内p H值为(6.17±0.01)^(6.49±0.01);48 h内组1~组3的不溶性微粒均符合2015版《中国药典》(四部)规定,然而组4在放置48 h后,≥10μm的不溶性微粒为14粒/m L,组5、组6制备后立即检测发现,≥25μm的不溶性微粒为3粒/m L,均不符合2015版《中国药典》(四部)要求;6组脂肪乳粒径为(236.7±6.8)^(267.2±11.6)nm,多分散系数为0.027~0.099;随着K^+浓度的增大,6组p H值(P=0.001)、粒度分布(P=0.043)存在一定的差异,且二者变化不满足任何一种直线或曲线趋势。结论:在室温下放置48 h内,K^+浓度≤50 mmol/L的处方,其外观、p H值、不溶性微粒和脂肪乳粒径大小均符合相关规定;而超过50 mmol/L的处方,其外观、p H值和脂肪乳粒径符合相关规定,但不溶性微粒不符合相关规定,临床使用需谨慎。OBJECTIVE:To investigate the effects of different concentrations of potassium ion(K+)on the stability of total parenteral nutrition(TPN),and to provide reference for clinical drug use.METHODS:TPN prescriptions containing different concentrations of different concentrations of K+(29.13,43.23,50.16,57.02,70.53,83.75 mmol/L,group 1-group 6)were designed.TPN infusion bag was prepared according to sterile operation procedure.The appearance,pH value,insoluble particle,particle size and granularity(polydispersity coefficient)of lipid emulsion at room temperature(25℃)were investigated after placing for 0,8,24,48 h.The effects of different concentrations of K+on the stability of TPN was investigated.RESULTS:There was no observable alteration in appearance color,stratification,flocculation and wall-hanging of 6 groups of TPN at 0,8,24,48 h after preparation.pH value for all groups were between(6.17±0.01)-(6.49±0.01)within 48 h at room temperature.The insoluble particles of group 1-3 within 48 h were in line with the regulations stated in 2015 edition of Chinese Pharmacopeia(partⅣ).However,insoluble particles≥10μm in group 4 was 14 grains/mL after placing 48 h,insoluble particles≥25μm in group 5 and group 6 were 3 grains/mL after preparation,which were not in line with the requirements of 2015 edition of Chinese Pharmacopeia(partⅣ).The particle sizes of lipid emulsion of 6 groups were between(236.7±6.8)-(267.2±11.6)nm;polydispersity coefficient for all groups were 0.027-0.099.With the increase of K+concentration,there is a certain difference between pH value(P=0.001)and granularity(P=0.043)of 6 groups;the change did not satisfy with any kind of straight line or curve trend.CONCLUSIONS:Placing 48 h at room temperature,in prescriptions of K+concentration≤50 mmol/L,appearance,pH value,insoluble particle and particle size of lipid emulsion are all in line with related regulations.In prescriptions of K+concentration>50 mmol/L.The appearance,pH value and particle size of lipid emulsion are all in line with relat

关 键 词：肠外营养液 钾离子浓度 稳定性 外观 pH值 不溶性微粒 脂肪乳粒径 粒度 

分 类 号：R927.11[医药卫生—药学] R913