小儿伤科泡腾颗粒剂的制备及处方优化  

Preparation and Formulation Optimization of Xiao’er Shangke Effervescent Granules

作　　者：温慧敏[1] 尹小娟[1] 杨沙[1] 陈诗韵 冯光富[1] 张忠[1] WEN Huimin;YIN Xiaojuan;YANG Sha;CHEN Shiyun;FENG Guangfu;ZHANG Zhong(Dept.of Pharmacy,Sichuan Orthopeadic Hospital,Sichuan Chengdu 610041,China;School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Sichuan Chengdu 610000,China)

机构地区：[1]四川省骨科医院药学部,四川成都610041 [2]成都中医药大学药学院,四川成都610000

出　　处：《中国医院用药评价与分析》2019年第11期1303-1305,共3页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：四川省中医药管理局青年中医药科研项目(No.2018QN030)

摘　　要：目的:建立并优化小儿伤科泡腾颗粒剂的制备方法。方法:以休止角、堆密度、吸湿率和溶化性等参数为综合评价指标,筛选稀释剂、泡腾剂、粘合剂、润滑剂及矫味剂的用量和种类。结果:优化的小儿伤科泡腾颗粒剂处方配比为乳糖为稀释剂,浸膏粉∶乳糖质量比为1∶1,聚乙二醇包合碳酸氢钠,柠檬酸为酸源,聚乙二醇6000∶碳酸氢钠∶柠檬酸=0.8∶1.0∶1.2,3%~7%聚乙烯吡咯烷酮K30的75%乙醇溶液为粘合剂,甜菊糖苷为矫味剂。按照该处方配比制备的小儿伤科腾颗粒,质量合格且稳定。结论:该泡腾颗粒剂处方优化合理,溶化时间和成型性均符合要求,且口感良好,质量稳定。OBJECTIVE: To establish and optimize the preparation method of Xiaoer Shangke effervescent granules. METHODS: With the parameters of angle of repose, bulk density, hydroscopicity and solubility as comprehensive evaluation indexes, the dosage and types of diluent, effervescent disintegrants, adhesive, lubricant, flavoring agents were screened. RESULTS: The optimal prescription ratio of Xiaoer Shangke effervescent granules was lactose as diluent, extract powder∶lactose mass ratio of 1∶1, polyethylene glycol coated sodium bicarbonate, citric acid as acid source, polyethylene glycol 6000∶sodium bicarbonate∶citric acid=0.8∶1.0∶1.2, 75% ethanol solution of 3%-7% polyvinylpyrrolidone K30 as adhesive, stevia glycoside as flavor correction. The quality of the granules prepared according to the formula was qualified and stable. CONCLUSIONS: The formulation of the effervescent granules has been optimized reasonably, and the dissolution time and molding property are in line with the requirements, with good taste and stable quality.

关 键 词：小儿伤科泡腾颗粒 制备 处方优化 

分 类 号：R932[医药卫生—生药学]