西青果口含片的处方研究  

Study on Formulation of Xiqingguo Buccal Tablet

作　　者：谢永红[1] 戴青[1] 赵鸿燕[1] 赵映兰[1] 刘芳[1] 刘松青[1] 

机构地区：[1]第三军医大学第一附属医院药剂科,重庆400038

出　　处：《中国药房》2017年第10期1386-1388,共3页China Pharmacy

基　　金：重庆市应用开发计划项目(No.cstc2014yykf A110023);第三军医大学科技成果转化基金资助项目(No.2013-XZH06)

摘　　要：目的:研究西青果口含片的处方,优选主要辅料的比例及用量。方法:以口含片外观、硬度、溶化性、口感为考察指标,采用正交设计优化主要辅料稀释剂(乳糖、甘露醇)、润湿剂(乙醇)、润滑剂(硬脂酸镁)和矫味剂(阿斯巴甜)的比例及用量,并考察所得处方颗粒的临界相对湿度。结果:采取湿法制粒法制粒;优化处方为乳糖与甘露醇比例1∶3、乙醇体积分数60%、薄荷脑用量0.4%、硬脂酸镁用量0.9%、阿斯巴甜用量2.0%、橘子香精用量0.4%;经验证试验得3批样品的总分为2.67、2.67、2.70(RSD=0.65%,n=3);颗粒临界相对湿度为60%。结论:优化处方制备得到的西青果口含片符合要求。OBJECTIVE：To study the formulation of Xiqingguo buccal tablet,optimize the proportion and quantity of main materials. METHODS：Using appearance,hardness,dissolution and taste as investigation indexes,orthogonal design was adopted to optimize the proportion and quantity of main thinner（lactose,mannitol）,wetting agent（ethanol）,lubricant（magnesium stearate）,flavoring agent（aspartame）,and critical relative humidity was detected. RESULTS：By wet granulation,the optimal formulation were as follows as the ratio of lactose and mannitol was 1 ∶ 3,ethanol volume fraction was 60%,the dosage of menthol,magnesium stearate,aspartame and orange essence was 0.4%,0.9%,2.0%,0.4%;it was proven that the total score of 3 batches of samples were 2.67,2.67,2.70（RSD=0.65%,n=3）,respectively. The critical relative humidity of granule was 60%. CONCLUSIONS：The Xiqingguo buccal tablet prepared by optimal prescription meets the requirements.

关 键 词：西青果 口含片 处方筛选 正交试验 临界相对湿度 

分 类 号：R283[医药卫生—中药学]