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中文摘要：
目的制备曲美他嗪双层渗透泵控释片并优化其处方。方法以含药层聚氧乙烯用量、助推层氯化钠用量、包衣增重为考察因素,药物的8 h累积释放度和0～8 h释放曲线的线性相关系数为考察指标,应用星点设计-效应面法对处方进行优化并验证。结果最优处方为含药层聚氧乙烯的用量86 mg,助推层氯化钠用量为25 mg,包衣增重7%。其释放曲线在0～8 h零级释放特征显著,8 h累积释放量达到89%以上,实测值与预测值无明显差异。结论采用星点设计-效应面法成功得到曲美他嗪双层渗透泵控释片的处方优化模型,实现了处方优化。
英文摘要：
AIM To prepare trimetazidine osmotic pump tablets and optimize its formulation by central composite design- response surface methodology （CCDRSM）. METHODS The amount of polyethylene oxide （PEO） which used as an adjuvant of trimetazidine pump tablets, the amount of NaC1, and the coating weight increase were used as three factors for investigation, and the cumulative release amount at 0 h to 8 h respectively, and the linear correlation coefficient （r） of the cumulative release amount versus time were taken as indexes. The formulation of trimetazidine was optimized by CCDRSM and the optimized formulation was verified. RESULTS The optimized formulation obtained was as follows： PEO 86 mg, NaCl 25 mg, and the coating weight increase 7%. A well zero-order release characteristic up to 0 - 8 h was achieved and cumulative release of TMZ was up to 89%. CONCLUSION The CCDRSM can be applied to optimize the formulation of trimetazidine and the established model is of satisfactory predictive value.
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