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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 the stability of the compound dextran 70 eye drops (including the preservative benzalkonium chloride) after unsealing during the course of its use by comprehensive physical, chemical and microbiological indexes to determine its service life after unsealing. Methods: The physical and chemical indexes such as pH, osmotic pressure and active ingredient content of 70 dextran eye drops were monitored regularly, sterilized and identified by bacteria. The variance of repeated measurement data was used to analyze the time of each group Point of pH, osmotic pressure and content of statistical analysis. Results: The stability of 70 dextran eye drops after uncapped at room temperature (25-28 ℃) and refrigerated (5-8 ℃) can not be considered as statistical stability. After the eye drops were unsealed The physical and chemical properties of the basic stability of the use of the first 29 days of bacterial culture positive. CONCLUSION: The compound dextran eye drops remain sterile and stable in physicochemical properties within 28 days after opening, so the service life after opening is tentatively scheduled to be 28 days.