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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 prescription and forming process of Peiyuan Granules, and provide references for the research and development of the prescription. Methods: Single factor test method was used to evaluate the granule forming, hygroscopicity and fluidity, and the prescription composition and forming process parameters of Peiyuan granule were optimized. The parameters such as water content, fluidity and bulk density of Peiyuan granule Determination. Results: The optimum prescription and molding process of Peiyuan Granules was dry powder - dextrin - soluble starch (5: 3: 3), wet granulation with 90% ethanol and dried at 60 ℃ for 1 h. Yield, moisture, angle of repose, bulk density and critical relative humidity were 95.78%, 5.08%, 30.73 °, 0.526 g · m L -1, 70% respectively. Conclusion: The prescription and molding process of Peiyuan Granules are reasonable and feasible. The moisture, liquidity and bulk density of granules are in line with the requirements of the 2010 edition of Chinese Pharmacopoeia.