β-(3,4-二羟基苯基)-α-羟基丙酸异丙酯滴丸制剂处方优化  

Optimization of formula for isopropyl 3-(3,4-dihydroxyphenyl)-2-hydroxypropanoate dropping pills

作　　者：韩姣姣[1] 曲秦 王玥月[1] 郑晓晖[1] 张亚军[1] 

机构地区：[1]西北大学生命科学学院,陕西西安710069 [2]陕西新药技术研究开发中心,陕西西安710075

出　　处：《中国医院药学杂志》2015年第20期1829-1833,共5页Chinese Journal of Hospital Pharmacy

基　　金：陕西省科技统筹创新工程计划(编号:2013KTCQ03-15);陕西省教育厅科学研究计划(编号:2013JK0812)

摘　　要：目的:优化β-(3,4-二羟基苯基)-α-羟基丙酸异丙酯(IDHP)滴丸的制剂处方。方法:采用Box-Behnken中心组合设计,以载药量、淀粉用量和羧甲基淀粉钠用量为自变量,总评归一化值(OD)为因变量,利用响应曲面法分析自变量对因变量的影响,确定滴丸剂较优处方并进行验证。结果:IDHP滴丸的最佳处方为:载药量为23.0%,淀粉用量为14.0%,CMS-Na用量为4.0%,PEG6000用量为59.0%。结论:试验所得处方合理,IDHP滴丸的成型质量良好。OBJECTIVE To optimize formula for isopropyl 3-（3,4-dihydroxyphenyl）-2-hydroxypropanoate（IDHP）dropping pills.METHODS Box-Behnken central composite design was adopted.Drug loading rate,amount of starch and sodium starch glycolate（CMS-Na）were taken as independent variables.General normalized value was taken as dependent variable.Response surface method was used to estimate relationship between dependent and independent variables,to optimize formula of IDHP.RESULTS The optimal formula was as follows：drug loading rate 23.0%,starch content 14.0%,CMS-Na 4.0% and PEG6000 59.0%.CONCLUSION The formula is reasonable,and the obtained IDHP dropping pills have good forming quality.

关 键 词：响应面法 β-(3 4-二羟基苯基)-α-羟基丙酸异丙酯滴丸 制剂处方 

分 类 号：R942[医药卫生—药剂学]