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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 the effects of five kinds of commonly used pharmaceutical excipients, microcrystalline cellulose (MCC), dextrin (DE), sodium carboxymethyl starch (CMS-Na), soluble starch (ST) and maltodextrin And its formability. Methods: A single adjuvant and two kinds of adjuvants were mixed with different proportions and mixed with Codonopsis pilosula by 1: 1 granulation respectively. The kinetics of Codonopsis pilosula fitting was fitted by Higuch equation, Weibull distribution and quadratic equation. With the combination of moldability and dissolvability, the best prescription for preparation of Codonopsis pilosula was screened. Results: When combined with CAC-MCC-DE (3: 2: 1), the granules could be completely dissolved within 2 min, the forming rate was 85.41%, and the equilibrium moisture absorption within 6.2 h %. Conclusion: The Codonopsis granules prepared according to the best prescription are good in moisture resistance and formability, and the process is stable and feasible, which can effectively reduce the hygroscopicity of Codonopsis granules.