无糖型银花感冒颗粒的成型工艺  

Molding Process of Sugarless Yinhua Ganmao Granules

作　　者：刘本涛 梁旭华 赵艳艳 贾朝 魏歌龙 周伟 孙金娟 程敏 LIU Bentao;LIANG Xuhua;ZHAO Yanyan;JIA Zhao;WEI Gelong;ZHOU Wei;SUN Jinjuan;CHENG Min(School of Pharmacy,Guangxi University of Chinese Medicine,Nanning 530200,China;College of Biology Pharmacy and Food Engineering,Shangluo University,Shangluo 726000,China;Shanxi Xiangju Pharmaceutical Group Co.,Ltd.,Shangluo 726000,China;School of Pharmacy,Shanxi University of Chinese Medicine,Xianyang 712046,China)

机构地区：[1]广西中医药大学药学院,南宁530200 [2]商洛学院生物医药与食品工程学院,商洛726000 [3]陕西香菊药业集团有限公司,商洛726000 [4]陕西中医药大学药学院,咸阳712046

出　　处：《医药导报》2020年第2期202-207,共6页Herald of Medicine

基　　金：陕西省教育厅服务地方科学研究计划(18JC011)

摘　　要：目的研究无糖型银花感冒颗粒的最佳成型工艺。方法考察不同辅料对颗粒成型性、溶化性、流动性和吸湿性的影响;利用综合评分法筛选制备无糖型银花感冒颗粒的最优辅料,并确定辅料之间最佳配比;采用Box-Behnken响应曲面法优化辅料加入量、乙醇体积分数及用量3个成型工艺参数。结果颗粒的最佳成型工艺条件为:糊精:乳糖:甘露醇=0.5:1:1.5,浸膏粉:辅料=1:2,以90%乙醇为润湿剂,用量为混合粉的10%,为减少水分对药物性质及稳定性的影响,环境湿度应控制<54%。结论该工艺可靠、稳定、重复性好,所制颗粒符合《中华人民共和国药典》2015年版四部“颗粒剂”项下要求,为无糖型银花感冒颗粒生产的工艺条件提供了参考依据。Objective To study the best formulation process for sugarless Yinhua Ganmao granules.Methods To investigate effects of different excipients on the formability,solubility,fluidity,and hydroscopicity of particles;The optimum excipients for the preparation of sugarless Yinhua Ganmao granules were screened by a comprehensive scoring method,and the best ratio among the excipients was determined.Box-Behnken response surface method was used to optimize three formulation process parameters,including the amount of excipients,the volume fraction of ethanol,and the amount of ethanol.Results The optimum process conditions for the granules were dextrin-lactose-mannitol=0.5:1:1.5,extract powder-excipients=1:2,90%ethanol as a wetting agent,and the dosage as 10%of the mixed powder.In order to reduce the influence of water on the properties and stability of the formulation,the environmental humidity should be controlled below 54%.Conclusion The process was reliable,stable,and reproducible.The granules met the requirements for“granules”in the fourth part of Pharmacopoeia of the Peoples Republic of China(2015 Edition).This study provided a reference for the production of sugarless Yinhua Ganmao granules.

关 键 词：无糖型银花感冒颗粒 Box-Behnken响应面法 成型工艺 

分 类 号：R285[医药卫生—中药学] TQ460.6[医药卫生—中医学]