双氯芬酸钠β-环糊精包合物滴眼液的制备

Preparation of Inclusion Complex of Diclofenac Sodium-β-Cyclodextrin Eyedrops

目的 :建立双氯芬酸钠 (DS)环糊精包合物滴眼液的制备方法。方法 :用搅拌法制备DS环糊精包合物 ,用仪器法鉴别其包合物 ,UV、HPLC法测定其含量。结果 :DS包合物的包合率为 (67 48±2 96) %。DS及其包合物的紫外吸收光谱完全一致。包合后DS的晶体衍射峰消失。结论 :DS/β-环糊精包合物可作为滴眼剂在临床上应用。

OBJECTIVE:To establish the preparation process of inclusion complex of diclofenac sodium-β-cyclodextrin (DS-β-CD) eyedrops METHODS:The DS-β-CD was prepared by the stir method and identified with instrumental method The content of diclofenac sodium was detected by UV,HPLC RESULTS:The inclusion ratio of DS-β-CD was(67 48±2 96)% There was no difference between diclofenac sodium and DS-β-CD in UV absorption spectrum The crystal diffraction peak of DS inclosed in DS-β-CD disappeared in X-ray CONCLUSION:The DS-β-CD can be used as eyedrops in clinical practice