复方右旋糖酐70滴眼液使用过程中的稳定性考察

发布时间：2019-06-15 00:01

【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。
[Abstract]:Objective: to study the stability of compound dextran 70 eye drops (containing preservative benzalkylamine) in the process of opening and sealing, and to determine the application period of compound dextran 70 eye drops after unsealing. Methods: the physical and chemical indexes such as pH, osmotic pressure and content of effective components in compound dextran 70 eye drops were regularly monitored, aseptic examination and strain identification were carried out. The pH value, osmotic pressure and content of each group at each time point were statistically analyzed by variance analysis of repeated measurement data. Results: the stability of compound dextran 70 eye drops under room temperature (25 鈮，

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