含新疆阿魏水提物及挥发油微囊的胃内漂浮片处方优选

Formulation Optimization of Gastric Floating Tablets Containing Aqueous Extract and Microencapsulated Volatile Oil of Ferula sinkiangensis K.M.Shen

以阿魏酸的体外释放为指标,采用正交设计与单因素试验相结合的方法优选胃内漂浮片处方组成。优化处方中HPMC K4M用量为70%、起泡剂[碳酸氢钠-枸橼酸(1∶0.76)混合物]用量为20%。所得漂浮片在0.1 mol/L盐酸中的平均起漂时间为(8.3±2.2)s,持续漂浮时间为(22.3±2.8)h。零级、Higuchi和Peppas方程都可较好地拟合本品中阿魏酸的释放行为,且其中阿魏酸的释放主要受骨架溶蚀机制控制。

The formulation of the gastric floating tablets containing aqueous extract and microencapsulated volatile oil ofFerula sinkiangensis K.M. Shen were optimized by orthogonal design and single factor test with the in vitro release of ferulic acid as the index. The average floating onset time and duration time of the optimal formulation with 70 % hydroxypropyl methyl cellulose （HPMC） K4M and 20% foaming agent （the mixture of sodium bicarbonate and citric acid with the ratio of 1 ： 0.76） in 0.1 mol/L HC1 were （8.3±2.2）s and （22.3±2.8）h, respectively. The zero-order, Higuchi and Peppas models all fit the release data of ferulic acid well. The mechanism for controlling the drug release was polymeric erosion.