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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 prepare diclofenac sodium flexible liposome gel for clinical use. METHODS: Diclofenac sodium flexible liposomes were prepared by ultrasonic dispersion method. The size and distribution of diclofenac sodium liposomes were observed with atomic force scanning probe microscope and ζ potential particle size analyzer. The entrapment efficiency of diclofenac sodium was determined by micro-dextran gel column method. Capsules as a control drug to observe the clinical efficacy of diclofenac sodium flexible liposome gel. Results: The average diameter of diclofenac sodium flexible liposomes was 89.6 nm, encapsulation efficiency was 38.6%. Treatment of rheumatoid arthritis patients in 24 cases, the total effective rate of 83%. Conclusion: This product meets the requirements of the gel, the exact effect, can be used in clinical trials.