注射用脂溶性维生素（Ⅱ）/水溶性维生素与常用电解质配伍的稳定性考察-中国药房

注射用脂溶性维生素（Ⅱ）/水溶性维生素与常用电解质配伍的稳定性考察

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篇名：	注射用脂溶性维生素（Ⅱ）/水溶性维生素与常用电解质配伍的稳定性考察
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摘要：	目的：考察注射用脂溶性维生素（Ⅱ）/水溶性维生素与常用电解质的配伍稳定性。方法：参考临床常用剂量，取注射用脂溶性维生素（Ⅱ）/水溶性维生素组合包装[含注射用脂溶性维生素（Ⅱ）2瓶和注射用水溶性维生素1瓶]分别与葡萄糖注射液、氯化钾注射液、浓氯化钠注射液、碳酸氢钠注射液、门冬氨酸钾注射液、门冬氨酸钾镁注射液、甘油磷酸钠注射液、多种微量元素注射液（Ⅱ）配伍，得配伍液A～H。在室温（25 ℃）下，分别于0、1、2、3、4 h时考察各配伍液的外观、pH值、渗透压摩尔浓度和不溶性微粒数，并于0、4 h时检查其细菌内毒素含量。结果：配制后4 h内，各配伍液外观无明显变化；配伍液H的pH值变化较大（RSD＝5.13％，n＝5），配伍液D和配伍液G的pH值明显升高；各配伍液的渗透压摩尔浓度均无明显变化（RSD＜2％，n＝5），且小于600 mOsmol/kg；各配伍液细菌内毒素检查结果均为阴性。配制后2、4 h时，配伍液B中≥10 μm的微粒数明显增加；配制后2、3、4 h时，配伍液E、F、H中≥10 μm的微粒数明显增加；配制后0、1、2、3、4 h时，配伍液G中≥10 μm的微粒数明显增加；上述配伍液中≥10 μm的微粒数与同时间点的配伍液A比较，差异均有统计学意义（P＜0.05），但均符合2015年版药典标准。配制后1、2、3、4 h时，配伍液D中≥10 μm的微粒数明显增加，与同时间点的配伍液A比较，差异均有统计学意义（P＜0.05）；且配制后2、3、4 h时≥10 μm的微粒数均超出药典规定范围。配制后4 h内，配伍液C中≥10 μm的微粒数和各配伍液中≥25 μm的微粒数均无明显变化，且符合药典标准。结论：由于pH值和不溶性微粒数变化较大，注射用脂溶性维生素（Ⅱ）/水溶性维生素不宜与多种微量元素注射液（Ⅱ）、甘油磷酸钠注射液或碳酸氢钠注射液配伍使用。
ABSTRACT：	OBJECTIVE： To investigate the compatibility stability of Fat-soluble vitamin （Ⅱ） /Water-soluble vitamin for injection with common electrolytes. METHODS： Referring to clinical common dose， Fat-soluble vitamin （Ⅱ） for injection /Water-soluble vitamin for injection collective packing [containing Fat-soluble vitamin（Ⅱ） for injection 2 ampoules and Water-soluble for injection 1 ampoule] were respectively mixed with Glucose injection， Potassium chloride injection， Concentrated sodium chloride injection， Sodium bicarbonate injection， Potassium aspartate injection， Potassium aspartate and magnesium aspartate injection， Sodium glycerophosphate injection， Multi-trace elements injection （Ⅱ） to obtain mixture A-H. At room temperature （25 ℃）， these mixtures were investigated in terms of appearance， pH value， osmotic pressure molar concentration and the number of insoluble particles at 0， 1， 2， 3， 4 h. The contents of bacterial endotoxin were tested at 0， 4 h. RESULTS： Within 4 h after mixing， there was no significant change in appearance of those mixtures； pH value of mixture H changed greatly （RSD＝5.13％， n＝5）， and that of mixture D and G increased significantly. The osmotic pressure molar concentration of those mixtures had no significantly change （RSD＜2％，n＝5） and lower than 600 mOsmol/kg. The bacterial endotoxin tests of those mixtures were negative. Two and four hours after mixing， the number of insoluble particles ≥10 μm in mixture B was increased significantly； 2， 3， 4 h after mixing， the number of insoluble particles ≥10 μm in mixture E， F， H were increased significantly； 0 ，1， 2， 3， 4 h after mixing， the number of insoluble particles ≥10 μm in mixture G was increased significantly. There was statistical significance in the number of insoluble particle ≥10 μm in above mixtures compared to mixture A at the same time point （P＜0.05）， but it was in line with the standard of 2015 pharmacopeia. One， two， three and four hours after mixing， the number of insoluble particle ≥10 μm in mixture D was increased significantly， there was statistical significance compared to mixture A at the same time point （P＜0.05）； the number of insoluble particle ≥10 μm in mixture D was beyond prescribed scope of pharmacopeia at 2， 3， 4 h after mixing. Within 4 h after mixing， both the number of insoluble particle ≥10 μm in mixture C and the number of insoluble particle ≥25 μm in edch mixture had no significant change， in accordance with pharmacopeia standard. CONCLUSIONS： Fat-soluble vitamin （Ⅱ）/Water-soluble vitamin for injection is not suitable for mixing with Multi-trace elements injection （Ⅱ）， Sodium glycerophosphate injection or Sodium bicarbonate injection due to great change of pH value and the number of insoluble particles.
期刊：	2017年第28卷第11期
作者：	范静，李相成，李飞，潘东，刘丽洁，李静，孙伟
AUTHORS：	FAN Jing， LI Xiangcheng， LI Fei， PAN Dong， LIU Lijie， LI Jing， SUN Wei
关键字：	注射用脂溶性维生素（Ⅱ）；注射用水溶性维生素；电解质；配伍；稳定性
KEYWORDS：	Fat-soluble vitamin for injection （Ⅱ）； Water-soluble vitamin for injection； Electrolyte； Compatibility； Stability
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