曲尼司特滴眼液的处方研究

Formulation Study of Eye Drops of Tranilast

摘要: 目的　增加曲尼司特的溶解度，筛选出合格的曲尼司特滴眼液处方。方法　以稳定性为指标，拟采用包合、增溶或助溶技术制备曲尼司特滴眼液。结果　以葡甲胺作助溶剂制备的曲尼司特滴眼液在光照(4 000 lx)、低温(4 ℃)、高温(60 ℃)10 d及室温留样考察12个月，物理及化学性质稳定。结论　研制的曲尼司特滴眼液达到设计要求。

Abstract: OBJECTIVE To screen good formulations of tranilast eye drops by solubilizing. METHODS Tranilast eye drops were prepared by inclusion compound or solubilizers method according to stability. RESULTS The physico-chemical stability was good after storing 10 d under illumination (4 000 lx), 4 ℃, 60 ℃ and 12 months under room temperature. CONCLUSION Tranilast eye drops could be made successfully.