阿托伐他汀钙片的处方工艺研究

Research on formulation and prescription of atorvastatin calcium tables

目的探究阿托伐他汀钙片的处方工艺。方法采用四因素三水平正交实验设计,以相似因子为评价指标,对风险评估确定的高风险因素羟丙纤维素用量、交联羧甲纤维素钠用量、包衣增重和聚山梨酯80用量进行考察,确定阿托伐他汀钙片的最佳处方工艺条件,并对优化的试验结果考察其体外溶出。结果最优用量为:羟丙纤维素2%、交联羧甲纤维素钠6%、聚山梨酯800.4%和包衣增重3%(2%~4%均可);体外溶出结果表明,四种溶出介质中f2因子均大于50,溶出行为与原研药相似。结论制备的阿托伐他汀钙片具有较理想的溶出行为,有进一步开发的价值。

Objective To explore the formulation and prescription of atorvastatin calcium tablets.Method The high risk factors identified by risk assessment were the amount of hydroxypropyl cellulose,the amount of croscarmellose sodium,the weight of coating and the amount of polysorbate 80,which were examined by four-factor three-level orthogonal experimental design,with a similarity factor as the evaluation index.The optimal formulation conditions for atorvastatin calcium tablets were determined.The optimized experimental results were used to investigate the in vitro dissolution.Result The optimum amount was:hydroxypropyl cellulose 2%,croscarmellose sodium 6%,polysorbate 804‰ and coating weight 3%(2% to 4%);The in vitro dissolution results showed that the f2 factors in the four dissolution media were all greater than 50,and the dissolution behavior was similar to that of the original drug.Conclusion The prepared atorvastatin calcium tablets have an ideal dissolution behavior and have the value of further development.