芍丹乙肝颗粒成型工艺的研究

Study on formulation process of Shaodanyigan Granule

目的 :确定芍丹乙肝颗粒剂的最佳制粒处方组成。方法:以颗粒吸湿百分率、成型率和溶化率为指标 ,筛选颗粒最佳辅料与配比。结果 :处方最佳组成为 :1份浸膏粉与 2份辅料 (乳糖∶甘露醇 =4∶ 1的混合辅料 )。所制颗粒吸湿率小 ,成型率高 ,溶化率高 ,临界相对湿度约为 72 %。

Objective: To ascertain the best formulation process of Shaodanyigan Granule. Methods: By determinating hygroscopicity,granulation and dissolubility, the appropriate excipient and its formula were selected. Result: The best excipient and its formula were one extract and two excipients which consisted of lactose and mannitol (4∶1, w/w). The made granules have low hygroscopicity and high granulation and high dissolubility. And its critical relative humidity is 72% or so. Conclusion: The experimental results provide the basis of the ascertainment of formulation process and the control of production enviroment of Shaodanyigan Granule