双氯芬酸钠柔性脂质体凝胶剂的制备及临床应用

Preparation and Clinical Application of Diclofenac Sodium Flexible Liposomes Gel

目的:制备双氯芬酸钠柔性脂质体凝胶并应用于临床。方法:用超声分散法制备双氯芬酸钠柔性脂质体,用原子力扫描探针显微镜及ζ电位粒度仪观测其大小及分布;用微型葡聚糖凝胶柱法测定其包封率,并以双氯芬酸钠胶囊为对照药,观察双氯芬酸钠柔性脂质体凝胶临床疗效。结果:双氯芬酸钠柔性纳米脂质体平均粒径89．6 nm,包封率38．6％。治疗类风湿关节炎患者24例,总有效率达83％。结论:本品符合凝胶剂的要求,疗效确切,可试用于临床。

Objective： To study the prepartion and clinical application of diclofenac sodium flexible liposomes gel. Method： The flexible liposomes were prepared through ultrasonication, their shape and diameter distibution were observed under the electronic microscope, Column chromatographic separation were used to study the encapsulation ratio of the flexible liposomes, and the clinical effect was observed and compared with the controlled group, Result： the mean diameter was about 89.6 nm, the encapsulated ratio was 38.6%. Conclusion： this preparation accordes with the gel＇s request of quality, the therapeutic effect is exact and can be tried to use in clinic.