5种常用药用辅料对党参颗粒吸湿性及成型性的影响

Effect of Five Kinds of Pharmaceutical Excipients on Moisture Absorption and Formability of Codonopsis Radix Granules

目的:研究5种常用药用辅料微晶纤维素(MCC),糊精(DE),羧甲基淀粉钠(CMS-Na),可溶性淀粉(ST)和麦芽糊精(MA)对党参颗粒吸湿及其成型性的影响。方法:以单一辅料,2种辅料不同配比混合后分别与党参浸膏按1∶1混合制粒,通过Higuch方程,Weibull分布和一元二次曲线方程模型拟合党参颗粒的吸湿动力学,并结合成型性和溶化性,筛选制备党参颗粒的最佳处方。结果:综合吸湿性和成型性,以党参浸膏-MCC-DE(3∶2∶1)组合时,党参颗粒均可在2 min内全溶,成型率85.41%,48 h内平衡吸湿量6.28%。结论:按最优处方所制党参颗粒的阻湿性和成型性均较好,工艺稳定可行,能有效降低党参颗粒的吸湿性。

Objective： To study on the effect of several medicinal excipients, such as microcrystalline cellulose （ MCC ）, soluble starch （ ST）, dextrin （ DE ）, mahodextrin （ MA ） and sodium carboxymethyl starch （CMS-Na）, on the moisture absorption and formability of Codonopsis Radix granules. Method： A single excipient or two kinds of excipients with different ratio were mixed with Codonopsis Radix extract by 1 ： 1, the moisture absorption kinetics of Codonopsis Radix granules was fitted by Higuch equation, Weibull distribution and unitary quadratic curve equation model, respectively. The best prescription of this granules was evaluated by the moisture absorption, forming and dissolubility. Result： Optimum molding materials was mixture of MCC and DE, ratio of Codonopsis Radix extract-MCC-DE was 3 ： 2 ： 1, Codonopsis Radix granules could be totally dissolved in 2 min with forming rate of 85.41%, equilibrium moisture content of this granules within 48 h was 6. 28%. Conclusion： The optimum process is stable and feasible, it can effectively reduce the hygroscopicity of Codonopsis Radix granules.