摘要
目的建立用于治疗特殊环境引起的变应性鼻炎和异位性皮炎的中成药制剂花敏颗粒的提取方法和制剂工艺,为院内制剂和商品化生产提供依据。方法本研究采用正交试验优选九味药的最佳提取工艺,进行制剂工艺研究,考察辅料的种类及最佳配比,将其制成颗粒剂。结果最终确定工艺为处方量药材加10倍量水煎煮3次,首次浸泡15 min,每次煎煮1 h,合并提取液浓缩,喷雾干燥,按药粉麦芽糊精甘露醇质量比为2∶1∶1并加3‰甜菊糖混合均匀,用900 mL/L乙醇制粒,干燥,制成颗粒1 kg,按10 g/袋装袋即得。结论该工艺稳定可行,为花敏颗粒的医院制剂注册和成果转化提供了实验依据。
Objective To establish the extraction method and preparation process of Huamin Granules,a traditional Chinese patent medicine used to treat allergic rhinitis and atopic dermatitis caused by special environment,so as to provide a basis for hospital preparation and commercial production.Methods In this study,an orthogonal experiment was used to optimize the extraction process of the nine herbal medicines.The preparation process was studied,the types and optimal ratio of excipients were investigated,and the granules were prepared.Results The final process was determined as follows:the prescribed amount of herbal materials were decocted and boiled in 10 times of water for 3 times,soaked for 15 min for the first time,and decocted for 1 h each time.The combined extracted solution was concentrated and spray-dried,and mixed evenly according to the mass ratio of powder-maltodextrin-mannitol of 2∶1∶1 with 3‰stevioside added.The mixture was granulated with 900 mL/L ethanol,dried,prepared into 1 kg of granules,and bagged according to 10 g/bag.Conclusion The process is stable and feasible,providing experimental evidence for the registration of Huamin Granules as a hospital preparation and the transformation of its achievements.
作者
朱瑞瑞
张永强
杨倩
周暄宣
王四旺
李捷
ZHU Ruirui;ZHANG Yongqiang;YANG Qian;ZHOU Xuanxuan;WANG Siwang;LI Jie(School of Pharmacy,Henan University,Kaifeng 475004,China;Department of Chinese Materia Medica and Natural Medicines,School of Pharmacy,Air Force Medical University,Xi'an 710032,China;Faculty of Life Sciences and Medicine,Northwest University,Xi'an 710069,China)
出处
《空军军医大学学报》
CAS
2023年第12期1190-1196,共7页
Journal of Air Force Medical University
基金
陕西省重点产业创新链社会发展领域重点研发计划项目(S2023-YF-ZDCXL-ZDLSF-0075)。
关键词
花敏颗粒
医院制剂
提取工艺
制剂工艺
变应性鼻炎
异位性皮炎
Huamin Granules
hospital preparation
extraction process
preparation process
allergic rhinitis
atopic dermatitis
作者简介
朱瑞瑞,硕士研究生,从事临床药学和中药新药研究,Tel:13186101097,E-mail:1461266915@qq.com;通信作者:李捷,Tel:15091524017,E-mail:lijie0290910@126.com;通信作者:王四旺,Tel:13909259880,E-mail:wangsiw@nwu.edu.cn。
