双氯芬酸钠眼用即型凝胶的研制

Preparation of the Diclofenac Sodium in situ Forming Eye Gel

目的:探讨双氯芬酸钠眼用即型凝胶的制备及质量控制方法。方法:以卡波姆-940为基质制备凝胶,采用高效液相色谱法测定双氯芬酸钠的含量。结果:本法线性关系良好,平均加样回收率为97.66%,RSD为0.62%。结论:本方法处方设计合理,制备方法简便,含量测定方法适用于本品质量控制。

Objective：To develop a preparation and quality control method for the diclofenac sodium in situ forming eye gel. Method：The diclofenac sodium in situ forming eye gel was prepared with carbopol as base and determined by HPLC. Result：The linearity of this method was well. The recovery of the added sample was 97.66% with RSD of 0.62%. Conclusion： The formulation of this preparation is reliable and preparation method is simple. The method of content determination is suitable for quality control of the preparation.