白芍总苷缓释滴丸的制备研究

Preparation of sustained-release dropping pills of total glucosides in Radix Paeoniae Alba

目的通过优化设计,研究白芍总苷缓释滴丸的处方和制备方法。方法以滴丸的硬度、圆整度和黏连度为评价指标,采用正交试验考察影响滴丸成型的因素。以12h的累积释放度为指标,采用均匀设计试验确定渗透性丙烯酸树脂缓控释包衣的最佳工艺和包衣组成。结果白芍总苷缓释包衣滴丸和体外释放符合缓释设计的要求,体外12h间隔的释放度符合一级动力学缓释特征。结论以渗透性丙烯酸树脂包衣的白芍总苷缓释滴丸制备工艺简便,具有良好的缓释特征。

Objective To optimize the formulation in preparation of dropping pills with total glucosides in Radix Paeoniae Alba and evaluate its accumulative release percentage in vitro. Methods With the hardness, roundness, and adhesion as the evaluation, orthogonal design was conducted. With dissolution rate of 12 h as the indices, according to the uniform design, the optimum coating formulation of Eudragit RL and RS was established. Results The dropping pills met the criterion of formulation, and the prepara- tion release met the characteristics of the sustained release of the first order kinetics. Conclusion The optimal formulation is simple, which provides the basis for further development of new preparations of total glucosides in Radix Paeoniae Alba.