摘要
通过对小儿消积止咳颗粒浸膏干燥条件、辅料种类、制粒条件的筛选,优选出干法制粒的最佳条件.通过Box-Behnken优选出小儿消积止咳颗粒浸膏的干燥条件,采用指纹图谱对比来保证浸膏干燥前后药效物质基础的一致性.以溶化性、成型性、吸湿率、流动性为考察指标筛选辅料种类及用量,最后通过Box-Behnken筛选最佳成型工艺.干燥条件为履带速度100 mm/min、干燥温度82℃、上料速度1.9 L/h.原辅料配比为干粉∶麦芽糊精∶三氯蔗糖∶硬脂酸镁=(1.28~1.30)∶(0.70~0.72)∶0.1‰∶1‰.制粒工艺为压片频率3 r/min,送料频率6 Hz,滚轮压力4 MPa.成型工艺稳定可行,为车间大生产提供数据支持、制剂的工艺变更提供理论支持.
By screening the drying conditions,excipient types,and granulation parameters of Xiaoer Xiaoji Zhike Granules,the optimal conditions for dry granulation were determined.The Box-Behnken design was employed to optimize the drying conditions for the granule extract,and fingerprint analysis was used to ensure the consistency of pharmacologically active components before and after drying.The excipient type and dosage were selected based on evaluation indicators such as solubility,formability,hygroscopicity,and flowability.Finally,the optimal granulation process was determined using the Box-Behnken design.The optimal drying conditions were a conveyor speed of 100 mm/min,drying temperature of 82℃,and feeding speed of 1.9 L/h.The ratio of raw material to excipients was dry powder∶maltodextrin∶sucralose∶magnesium stearate=(1.28~1.30)∶(0.70~0.72)∶0.1‰∶1‰.The granulation parameters were a tableting frequency of 3 r/min,feeding frequency of 6 Hz,and roller pressure of 4 MPa.The granulation process is stable and feasible,providing data support for large-scale production and theoretical support for process modifications in pharmaceutical preparation.
作者
姜明月
曹继祥
张兰
李红
庄会芳
白雪
王永刚
JIANG Ming-yue;CAO Ji-xiang;ZHANG Lan;LI Hong;ZHUANG Hui-fang;BAI Xue;WANG Yong-gang(State Key Laboratory of generic technology of traditional Chinese medicine pharmacy,Linyi 276005,China;Lunan Houpu Pharmaceutical Co.Ltd.,Linyi 276005,China)
出处
《云南民族大学学报(自然科学版)》
2025年第4期436-445,463,共11页
Journal of Yunnan Minzu University(Natural Sciences Edition)
基金
山东省重点研发计划(重大科技创新工程)(2021CXGC010508)
山东省新旧动能转换重大产业攻关项目(鲁动能办[2021]23号)。
