盐酸格拉司琼注射液在玻璃瓶和PVC软袋输液中的稳定性考查  

Compatibility of granisetron hydrochloride towards glass and plastics and its stability under various storage conditions

作　　者：陈丽佳[1] 吴伟明[1] 王蕾[1] 

机构地区：[1]温州医学院附属第二医院药剂科,温州325027

出　　处：《海峡药学》2007年第12期15-16,共2页Strait Pharmaceutical Journal

摘　　要：目的考查盐酸格拉司琼注射液在玻璃瓶和PVC软袋(聚氯乙烯输液袋)输液中的稳定性是否存在差异。方法盐酸格拉司琼分别以生理盐水(NS)和5%葡萄糖(GS)注射液配制于玻璃瓶和PVC软袋中,于4℃、25℃、37℃下放置24h,分别于0、1、2、4、6、8、12和24h取样,检测其外观、含量和有关物质,其中含量和有关物质以高效液相色谱法(RP-HPLC)进行检测。结果盐酸格拉司琼在各条件下于玻璃瓶和PVC软袋输液中各检测项目均无明显变化,2组之间无显著性差异(P>0.05)。结论盐酸格拉司琼在各条件下均较稳定,其在玻璃瓶和PVC软袋输液中的稳定性无差异。OBJECTIVE To investigate the compatibility of granisetron hydrochloride towards glass and plastics bag（PVC） and its stability under various storage conditions. METHODS Granisetron hydrochloride was dissolved with 5% glucose injection and 0. 9% sodium chloride injection respectively in glass containers and PVC bags. The storage conditions for the solutions were 4℃ ,25℃ and 37℃. Samples were removed at 0,1,2,4,6,8,12and 24h, and their appearance, concentrations were determined. Granisetron hydrochloride concentrations were determined by HPLC. RESULTS There were no obvious changes founded in granisetron hydrochloinde under different conditions. And the statistic results had no significant difference（P 〉0. 05）. CONCLUSION Graniserton hydrochloride is stable in glass container and PVC bag in 5% glucose injection and 0. 9% sodium chloride injection.

关 键 词：盐酸格拉司琼 玻璃瓶 PVC袋 稳定性 HPLC 

分 类 号：TQ460.4[化学工程—制药化工]