摘要
目的:对比胶囊剂制备过程中不同干燥工艺对有效成分及制剂质量的影响,并通过优化辅料增强制剂的抗湿性和稳定性。方法:煎煮浓缩制备提取物浸膏,分别采用真空干燥和喷雾干燥工艺处理,以绿原酸含量、崩解度、水分等为指标考察2种干燥工艺对成品质量的影响;同时,采用平衡吸湿法考察糊精、乳糖、甘露醇、木糖醇等辅料对制剂吸湿性影响。结果:喷雾干燥制备的浸膏能最大限度的保存有效成分绿原酸含量,以浸膏:糊精(2:1)喷雾干燥后制成的胶囊剂具有崩解度快,水分含量低,不易吸湿等优点。结论:经干燥工艺筛选及辅料优化后的抗感冒胶囊性质稳定,单次服用量小,且较抗感冒颗粒更能改善病人的顺应性和扩大病患适用群体,故能够投入大工业生产。
Objective： To compare the results which were obtained by using two different drying methods on Kang Ganmao capsule and to optimize excipient to enhance its stability. Methods： We utilized several indexes to investigate the better drying method and the better excipient. Results： Kang Ganmao capsule using dextrin as excipient which was prepared by spray drying showed its superiority. Conclusion： The improved preparation of Kang Ganmao capsule is suitable for the industrial production.
出处
《抗感染药学》
2008年第2期96-99,共4页
Anti-infection Pharmacy
基金
国家科技支撑计划(编号:2006BAI09800)
科技部中小企业技术创新基金(立项代码:07C26223201333)
关键词
抗感冒胶囊
干燥工艺
绿原酸
吸湿平衡曲线
Kang Ganmao capsule
drying method
chlorogenic acid
moisture absorption curve
