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 related regulations,but insoluble particle is not in line with related regulations and should be used cautiously in clinic.
作者
杜珮瑜
郑雪花
李晓冰
高宇
接丽莉
杨跃辉
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)
出处
《中国药房》
CAS
北大核心
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)
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
Total parenteral nutrition
K+concentration
Stability
Appearance
pH value
Insoluble particles
Particle size of lipid emulsion
Granularity
