珍珠滴眼凝胶的渗透压测定

Determination of Osmotic Pressure on the Pearl Ophthalmic Gel

目的:探讨全自动冰点渗透压计测定珍珠滴眼凝胶渗透压值方法的可行性和准确性。方法:使用全自动冰点渗透压计测定珍珠滴眼凝胶的渗透压值,并对其制备及稳定性考察过程中的渗透压值进行监控。结果:该制剂渗透压值符合眼用制剂的要求,经过长期室温留样试验和加速试验,渗透压值没有明显变化,表明该制剂质量稳定。结论:该方法简便、快速、实用,可作为珍珠滴眼凝胶渗透压检测的手段。

Objective： To establish the osmotic pressure measurement method for the pearl eye gel. Methods：The osmotic pressure on the ophthalmic gel was determinated by the instrument for automatic freezing point of osmotic pressure,and which was monitored in the inspection process of the preparation and stablity. Results： After a long stay at room temperature sample test and a accelerated test, the osmotic pressure values didn＇t change significantly, which showed that the quality of the preparation was stable. Conclusion： The osmotic pressure of the eye gel was in line with the requirements of ophthalmic preparations, and the method was simple, fast and practical, which can be used as means of osmotic pressure test for the pearl ophthalmic gel.