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作 者:郭洁芬 景莎莎 赵喜玲 温锦荣 景瑞超 徐艳 Guo Jie-fen;Jing Sha-sha;Zhao Xi-ling;Wen Jin-rong;Jing Rui-chao;Xu Yan(Xi'an Wanlong Pharmaceutical Co.,Ltd.,Xi'an 710119)
出 处:《国外医药(抗生素分册)》2021年第5期316-320,共5页World Notes on Antibiotics
摘 要:目的优选头孢地尼干混悬剂的处方。方法以参比制剂处方组成为基础,通过正交实验对絮凝剂、助悬剂、助流剂处方用量进行筛选,再考察不同润湿剂制粒对产品质量的影响,筛选出最佳处方。结果无水柠檬酸:无水柠檬酸钠为1:1,黄原胶:瓜尔胶为1:4,二氧化硅用量为处方总量的1.0%,润湿剂选择水溶液为最佳处方。结论优选的处方各项质量指标均合格。Objective To optimize the formulation of cefdinir dry suspension.Methods Based on the formula composition of reference preparation,the prescription dosage of flocculant,suspending and glidant agent were optimized by orthogonal experiment design,and the influence of different kinds of wetting agents on product quality was investigated,through which the best formulation was selected.Results A ratio of anhydrous citric acid to anhydrous sodium citrate of 1 to 1,a ratio of Xanthan gum to guar gum of 1 to 4,1.0%of silicon dioxide was used in the total formulation,and water were proved to be the optimum condition of preparing cefdinir dry suspension.Conclusion All the quality parameters of the optimized formulation were qualified.
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