摘要
目的优化通脉无蔗糖颗粒的制备工艺。方法以颗粒的成型率、溶化率、休止角、吸湿率的综合评分OD值为评价指标,采用D-optimal试验筛选稀释剂配比,Box-Behnken试验优化其成型工艺。结果混合稀释剂最佳配比为乳糖∶甘露醇∶可溶性淀粉=0.44∶0.30∶0.26,最佳成型工艺参数为主药∶稀释剂的配比为1∶1.54,74%乙醇用量为39%。结论建立的方法稳定可行,所制得颗粒符合颗粒剂质量要求,可为其后续研究开发提供理论依据。
Objective To optimize the preparation process of Tongmai sucrose-free granules.Methods The comprehensive score OD value of the molding rate,melting rate,angle of repose and hygroscopicity of the granules is used as the evaluation index.The D-optimal design is used to screen the mixing ratio of diluents,and the Box-Behnken design is used to optimize the process parameters.Results The optimal ratio of mixing diluents is lactose:mannitol:soluble starch ratio of 0.44:0.30:0.26,and the optimal molding process parameters ratio of main drug and diluents is 1:1.54,and the dosage of 74%ethanol is 39%.Conclusion The method is stable and feasible,and the obtained granules meet the quality requirements of granules,which provides a theoretical basis for its subsequent research and development.
作者
王萍
许刚
王宇鹤
张瑞瑞
廖予菲
WANG Ping;XU Gang;WANG Yu-he;ZHANG Rui-rui;LIAO Yu-fei(College of Medicine,Shaanxi Institute of International Trade&Commerce,Xi’an 712046,China;Collaborative Innovation Center of Green Manufacturing Technology for Traditional Chinese Medicine in Shaanxi Province,Xi’an 712046,China;Shaanxi Buchang Pharmaceutical Co.,Ltd.,Xi'an 710075,China;The Affiliated Hospital of Xizang Minzu University,Xianyang 712082,China)
出处
《现代中药研究与实践》
CAS
2022年第3期74-78,共5页
Research and Practice on Chinese Medicines
基金
陕西中医药管理局项目(2021-ZZ-ZY006)
陕西国际商贸学院创新团队项目(SSY18TD02)
陕西省中药产业技术创新服务共享平台项目(2018PF-07)。
