水杨酸钠微多孔渗透泵控释片的研制

Preparation of controlled porosity osmotic pump tablets of sodium salicylate

目的制备水杨酸钠渗透泵控释片。方法考察各因素对药物释放的影响,采用均匀设计优化处方中影响药物释放的主要因素,预测最优处方,制备水杨酸钠渗透泵控释片,进行体外释放试验。结果最佳处方为:酒石酸用量30 mg,DEP用量23%,PEG用量3%,包衣增重4%,3批样品在12 h内体外释放符合零级过程。结论微孔膜控型水杨酸钠渗透泵控释片可行,可以达到设计的要求。

Objective To prepare controlled porosity osmotic pump tablets of sodium salicylate. Methods The factor influencing the drug release was investigated by the single factor investigation. Uniform design was used to get the quantitative relationship among the release rate and formula factors. Controlled porosity osmotic pump tablets of sodium salicylate was prepared and the release profile was determined in vitro, l^esults Three batches of controlled porosity osmotic pump tablets of sodium salicylate was prepared. The optimum formulation： tartaric acid, 30 rag; DEP, 23% ; PEG, 3% ; and the membrane thickness was 4% （as the percent of the core）. The drug release pattern was in accordance with zero-order kinetics. Conclusion This method to prepare controlled porosity osmotic pump tablets of sodium salicylate was applicable with ideal controlled drug release.