复方右旋糖酐70滴眼液使用过程中的稳定性考察  

Stability of compound dextran-70 eye drops in clinical application

作　　者：宫瑞中[1] 王丽[1] 张红[1] 张琳[1] 王婧[1] 王峻峰[1] 冀明[1] 王琛[1] 

机构地区：[1]山西省眼科医院,山西太原030002

出　　处：《中国医院药学杂志》2015年第23期2136-2139,共4页Chinese Journal of Hospital Pharmacy

基　　金：山西省科技厅基金(编号:20120313024-8)

摘　　要：目的：综合物理、化学和微生物学指标对复方右旋糖酐70滴眼液（含防腐剂苯扎氯胺）开封后在使用过程中的稳定性进行研究,确定其开封后的使用期限。方法：对复方右旋糖酐70滴眼液使用过程中pH、渗透压、有效成分含量等理化指标进行定期监测并进行无菌检查和菌种鉴定等,应用重复测量数据的方差分析分别对各组各时间点的pH值、渗透压及含量进行统计学分析。结果：复方右旋糖酐70滴眼液开封后在室温（25～28℃）和冷藏（5～8℃）等使用环境下的稳定性尚不能认为有统计学差异,监测期内该滴眼液开封后的理化性质基本稳定,使用过程中的第29天细菌培养阳性。结论：复方右旋糖酐滴眼液开封后28 d内可保持无菌且理化性质相对稳定,因此开封后的使用期限暂定为28 d。OBJECTIVE To study stability of compound dextran-70 eye drops with benzalkonium chloride as preservative in clinical application by observing physical,chemical and microbiological properties,and determine expiration date after opened.METHODS For compound dextran-70 eye drops,we regularly monitored pH,osmotic pressure,content of effective composition,performed sterility test and strain identification,and analyzed the observed differences by repetitive measurement and analysis of variance among all the groups at each time point.RESULTS Stability of compound dextran-70 eye drops under room temperature（25-28 ℃）and in refrigerator（5-8 ℃）showed no statistically significant difference.Physicochemical property was relatively stable and sterility test showed bacteria were not positive until 29 days after container opening.CONCLUSION Compound dextran-70 eye drops can keep sterile and stable physicochemical properties within 28 days after opening the container,and expiration date is estimated to be 28 days.

关 键 词：复方右旋糖酐70滴眼液 临床应用 稳定性 

分 类 号：R988.1[医药卫生—药品]