Williams N A, Bornstein M, Johnson K
R. W. Johnson Pharmaceutical Research Institute, Raritan, NJ 08869, USA.
Am J Health Syst Pharm. 1996 Oct 1;53(19):2309-13. doi: 10.1093/ajhp/53.19.2309.
The stability of levofloxacin in 10 commonly used infusion fluids was studied. Levofloxacin 25-mg/mL injection was diluted to 0.5 and 5 mg/mL in each of the following i.v. infusion fluids: 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, 5% dextrose and lactated Ringer's injection, 5% sodium bicarbonate injection, Plasma-Lyte 56 and 5% dextrose injection, 5% dextrose and 0.45% sodium chloride and 0.15% potassium chloride injection, 1/6 M sodium lactate injection, sterile water for injection, and 20% mannitol injection. Ten polyvinyl chloride bags were prepared for each solution; two were stored for 3 days at 25 degrees C, two for 7 days at 5 degrees C, two for 14 days at 5 degrees C, two for 13 weeks at -20 degrees C followed by 14 days at 5 degrees C, and two for 26 weeks at -20 degrees C, all in the dark. The solutions were visually examined, tested for turbidity and particulate matter, and subjected to stability-indicating high-performance liquid chromatography; solution pH was determined. Levofloxacin was stable in and compatible with all but two of the diluents tested. Precipitation occurred under all conditions in 20% mannitol injection for the 0.5-mg/mL levofloxacin concentration and after storage for 13 weeks at -20 degrees C for the 5-mg/mL concentration. Levofloxacin 0.5 mg/mL in 5% sodium bicarbonate injection formed a precipitate when stored at -20 degrees C for 13 weeks and beyond. Levofloxacin 0.5 and 5 mg/mL was compatible with and stable in 8 of the 10 infusion fluids studied.
研究了左氧氟沙星在10种常用输液中的稳定性。将25mg/mL的左氧氟沙星注射液分别稀释至0.5mg/mL和5mg/mL，置于以下静脉输液中：0.9%氯化钠注射液、5%葡萄糖注射液、5%葡萄糖与0.9%氯化钠注射液、5%葡萄糖与乳酸林格氏注射液、5%碳酸氢钠注射液、Plasma-Lyte 56与5%葡萄糖注射液、5%葡萄糖与0.45%氯化钠和0.15%氯化钾注射液、1/6M乳酸钠注射液、注射用水和20%甘露醇注射液。每种溶液制备10个聚氯乙烯袋；两个在25℃下储存3天，两个在5℃下储存7天，两个在5℃下储存14天，两个在-20℃下储存13周后在5℃下再储存14天，两个在-20℃下储存26周，均在暗处。对溶液进行外观检查、浊度和微粒检测，并进行稳定性指示高效液相色谱分析；测定溶液pH值。除两种测试稀释剂外，左氧氟沙星在其他所有稀释剂中均稳定且相容。在所有条件下，0.5mg/mL左氧氟沙星浓度的溶液在20%甘露醇注射液中均出现沉淀，5mg/mL浓度的溶液在-20℃下储存13周后出现沉淀。5%碳酸氢钠注射液中0.5mg/mL的左氧氟沙星在-20℃下储存13周及更长时间时会形成沉淀。在所研究的10种输液中，0.5mg/mL和5mg/mL的左氧氟沙星与其中8种相容且稳定。
