培元颗粒的处方与制备工艺考察

Investigation of Formulation and Preparation Process of Peiyuan Granules

目的:优选培元颗粒的处方与成型工艺,为该方的研究与开发提供参考。方法:采用单因素试验法,以颗粒成型性、吸湿性、流动性为评价指标,优选培元颗粒的处方组成和成型工艺参数,并对培元颗粒的水分、流动性、堆密度等参数进行测定。结果:培元颗粒的最佳处方与成型工艺为干膏粉-糊精-可溶性淀粉(5∶3∶3),以90%乙醇为润湿剂,湿法制粒,60℃干燥1 h。收率、水分、休止角、堆密度及临界相对湿度分别为95.78%,5.08%,30.73度,0.526 g·m L-1,70%。结论:优选的培元颗粒处方与成型工艺合理、可行,颗粒剂的水分、流动性、堆密度均符合2010年版《中国药典》的规定。

Objective： To optimize formulation and preparation process of Peiyuan granules which will provide scientific references for clinical development of Peiyuan granules. Method： Single factor tests were performed to choose formulation and preparation process,with formability,hygroscopicity and fluidity as indexes.Moisture content,fluidity,bulk density and critical relative humidity of Peiyuan granules were inspected. Result：Optimum process conditions of Peiyuan granules were as follows： dry extract powder-dextrin-soluble starch（ 5∶ 3∶ 3）,wetting agent of 90% ethanol,wet granulation dried at 60 ℃ for 1 h. Yield,moisture content,angle of repose,bulk density and critical relative humidity were 95. 78%,5. 08%,30. 73°,0. 526 g·m L- 1,70%. Conclusion：This formation process is reasonable and feasible. Moisture content,fluidity and bulk density of Peiyuan granules are up to requirements of the 2010 edition of Chinese Pharmacopoeia.