【摘要】：目的:綜合物理、化學(xué)和微生物學(xué)指標(biāo)對(duì)復(fù)方右旋糖酐70滴眼液(含防腐劑苯扎氯胺)開封后在使用過程中的穩(wěn)定性進(jìn)行研究,確定其開封后的使用期限。方法:對(duì)復(fù)方右旋糖酐70滴眼液使用過程中pH、滲透壓、有效成分含量等理化指標(biāo)進(jìn)行定期監(jiān)測(cè)并進(jìn)行無菌檢查和菌種鑒定等,應(yīng)用重復(fù)測(cè)量數(shù)據(jù)的方差分析分別對(duì)各組各時(shí)間點(diǎn)的pH值、滲透壓及含量進(jìn)行統(tǒng)計(jì)學(xué)分析。結(jié)果:復(fù)方右旋糖酐70滴眼液開封后在室溫(25~28℃)和冷藏(5~8℃)等使用環(huán)境下的穩(wěn)定性尚不能認(rèn)為有統(tǒng)計(jì)學(xué)差異,監(jiān)測(cè)期內(nèi)該滴眼液開封后的理化性質(zhì)基本穩(wěn)定,使用過程中的第29天細(xì)菌培養(yǎng)陽(yáng)性。結(jié)論:復(fù)方右旋糖酐滴眼液開封后28 d內(nèi)可保持無菌且理化性質(zhì)相對(duì)穩(wěn)定,因此開封后的使用期限暫定為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，

本文編號(hào)：2499811