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Box-Behnken设计-效应面法优选四逆泡腾片干法制粒工艺
引用本文:傅 亮,余晓耕,谭和平,卢庆红,雷光远,姜 颖,罗晓健. Box-Behnken设计-效应面法优选四逆泡腾片干法制粒工艺[J]. 中国药房, 2014, 0(3): 224-227
作者姓名:傅 亮  余晓耕  谭和平  卢庆红  雷光远  姜 颖  罗晓健
作者单位:[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
基金项目: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。

关 键 词:干法制粒  Box-Behnken设计-效应面法  四逆泡腾片

Optimization of Dry Granulation Technology of Sini Effervescent Tablets by Box-Behnken Design and Response Surface Method
FU Liang,YU Xiao-geng,TAN He-ping,LU Qing-hong,LEI Guang-yuan,JIANG Ying,LUO Xiao-jian. Optimization of Dry Granulation Technology of Sini Effervescent Tablets by Box-Behnken Design and Response Surface Method[J]. China Pharmacy, 2014, 0(3): 224-227
Authors:FU Liang  YU Xiao-geng  TAN He-ping  LU Qing-hong  LEI Guang-yuan  JIANG Ying  LUO Xiao-jian
Affiliation:2 ( 1.Jiangxi Children's Hospital, Nanchang 330006, China; 2. National Pharmaceutical Engineering Center for TCM Solid Preparation, Jiangxi University of TCM, Nanchang 330006, China)
Abstract: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.
Keywords:Dry granulation  Box-behnken design-response surface method  Sini effervescent tablets
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