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目的:制备双氯芬酸钠微孔渗透泵片并对其体外释药行为进行考察。方法:采用正交试验设计优选渗透压促进剂氯化钠、致孔剂PEG400和增塑剂DBP的含量以及包衣膜增重,并对双氯芬酸钠微孔渗透泵片体外释药行为进行模型拟合。结果:最佳处方为氯化钠25mg,PEG400 20%,DBP10%,包衣增重8mg。制得的双氯芬酸钠微孔渗透泵片在12h内呈现零级控释释放特征(r2=0.998 7),累积释药率为90.54%。结论:将双氯芬酸钠制备成微孔渗透泵片可以实现理想的药物控制释放。
Objective: To prepare diclofenac sodium microporous osmotic pump tablets and study its in vitro release behavior. Methods: The orthogonal experiment was used to optimize the osmotic pressure enhancer sodium chloride, pore-forming agent PEG400 and plasticizer DBP weight, as well as weight gain of coating film. The in vitro release behavior of diclofenac sodium microporous osmotic pump tablets was simulated Together Results: The best prescription was sodium chloride 25mg, PEG400 20%, DBP 10%, coating weight gain 8mg. The diclofenac sodium microporous osmotic pump tablets showed zero-order controlled release (r2 = 0.998 7) within 12h, and the cumulative release rate was 90.54%. CONCLUSIONS: Diclofenac sodium is prepared as a microporous osmotic pump tablet for optimal drug controlled release.