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芍丹乙肝颗粒成型工艺的研究
Study on formulation process of Shaodanyigan Granule
【摘要】 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 %。结论:实验结果可为芍丹乙肝颗粒制剂处方组成的确定及生产环境的控制提供实验依据
【Abstract】 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
【Key words】 Shaodanyigan Granule; formulation process; critical relative humidity;
- 【文献出处】 新疆医科大学学报 ,Journal of Xinjiang Medical University , 编辑部邮箱 ,2004年02期
- 【分类号】TQ461
- 【被引频次】18
- 【下载频次】131