Box-Behnken设计-效应面法优选四逆泡腾片干法制粒工艺  

Optimization of Dry Granulation Technology of Sini Effervescent Tablets by Box-Behnken Design and Response Surface Method

作　　者：傅亮[1] 余晓耕[1] 谭和平[1] 卢庆红[1] 雷光远[1] 姜颖[2] 罗晓健[2] 

机构地区：[1]江西省儿童医院,南昌330006 [2]江西中医药大学中药固体制剂制造技术国家工程研究中心,南昌330006

出　　处：《中国药房》2014年第3期224-227,共4页China Pharmacy

基　　金：国家科技重大新药创制项目(No.2009ZX09310-005)

摘　　要：目的:优选四逆泡腾片干法制粒工艺。方法:以颗粒得率和颗粒脆碎度为评价指标,以轧轮压力、轧轮转速、浸膏粉含水量为考察因素,采用单因素试验考察各因素对指标的影响程度;采用Box-Behnken设计考察各因素对评价指标总评OD值的影响,并采用效应面法预测、分析、选取最佳工艺。结果:最佳干法制粒工艺为浸膏粉含水量为2.1%,轧轮转速为8.8 Hz,轧轮压力为2.3 MPa。结论:所选工艺稳定、可行、重现性好,可用于四逆泡腾片的制粒。OBJECTIVE： To optimize the dry granulation technology of Sini effervescent tablets. METHODS： The influence of roller press, roller speed and the water content of extract powder on yield and friability of particle were investigated with single factor test. The effects of those factors on OD value were investigated by Box-Behnken design, and response surface method was used to predict, analyze and select optimal technology. RESULTS： The optimal dry granulation technology was as follows： the water content of extract powder of 2.1%, the roller speed of 8.8 Hz, and roller press of 2.3 MPa. CONCLUSIONS： The technology is stable, feasible and reproducible for the granulation of Sini effervescent tablets.

关 键 词：干法制粒 Box—Behnken设计-效应面法 四逆泡腾片 

分 类 号：R284.2[医药卫生—中药学] R283[医药卫生—中医学]