人参皂苷Rg_3固体分散体渗透泵片的研制及体外释放度考察

Preparation of osmotic pump tablets ginsenoside Rg_3 of solid dispersion and its release characteristic in vitro

目的通过体外溶出实验比较人参皂苷Rg3固体分散体的单层和双层渗透泵片在释药行为上的差异及各自的优劣。方法分别制备人参皂苷Rg3固体分散体增溶型单层渗透泵片和双层渗透泵片,并对处方中的影响因素:渗透压活性物质的种类和用量、助悬剂的用量、包衣液中致孔剂的用量和包衣厚度进行优化,通过体外溶出实验对比2种制剂的释药行为。结果制备的人参皂苷Rg3固体分散体单层渗透泵片和双层渗透泵片均符合零级释放,对2种制剂分别与零级释药模型进行拟合,拟合系数分别为r1=0.998 1,r2=0.990 6。结论人参皂苷Rg3双层渗透泵片比单层渗透泵片释药更加完全,但是制备工艺比单层渗透泵片复杂。

Objective To compare the differences on release behaviors between the mono-layer and two-layer osmotic pump tablets of ginsenoside Rg3 solid dispersion and to find out the advantages and disadvantages of each preparation.Methods The mono-layer and two-layer osmotic pump tablets of ginsenoside Rg3 solid dispersion were prepared and the prescription optimization was examined by comparing the in vitro release behaviors such as type and amount of the osmotic active substances,amount of suspending agent,amount of porogen in the coating solution,and thickness of the coating.Results Mono-layer and two-layer osmotic pump tablets were well accorded with the zero-order equation.Fitting with the zero-order release model,the coefficients of the mono-layer and two-layer osmotic pump tablets were r1 = 0.998 1 and r2 = 0.990 6,respectively.Conclusion Two-layer Rg3 osmotic pump tablets could release more completely than mono-layer osmotic pump tablets,but have more complex preparation process.