均匀设计法优化生脉分散片处方  

Formula Optimization of Shengmai Dispersible Tablets by Uniform Design

作　　者：邓浩[1] 朱志军[1] 高松[1] 李莹丽[1] 蒋亚超[1] 张楠楠[1] 

机构地区：[1]河南中医学院,郑州450008

出　　处：《中国药师》2016年第10期1980-1983,共4页China Pharmacist

摘　　要：目的:探讨生脉分散片的处方与制备工艺参数。方法:以分散片的制粒情况,崩解时限,脆碎度,口感等为考察指标,采用均匀设计法优选生脉分散片的处方与成型工艺。结果:最佳生脉分散片处方为:浸膏粉25%、MCC 58%、CCMCNa8%、CMS-Na 4%、L-HPC 2%、硬脂酸镁2%、甜菊糖1%,其中L-HPC、硬脂酸镁外加,片硬度为25N;优选出的分散片处方崩解时限小于3 min。结论:优选的生脉分散片处方与制备工艺参数稳定可靠,重复性较好,工艺可行。Objective： To explore the formula and preparation technology parameters of Shengmai dispersible tablets. Methods： With the granulation status, disintegration time, friability, taste and and so on as the testing indices, the formula and preparation tech- nology of Shengmai dispersion tablets were optimized by uniform design. Results： The optimized formula of Shengrnai dispersible tab- lets was as follows： 25% extract powder, 58% MCC, 8% CCMC-Na, 4% CMS-Na, 2% L-HPC, 2% magnesium stearate and 1% sweetener. L-HPC and magnesium stearate were added after the granulation, and the tablet hardness was controlled at 25N. The opti- mized dispersible tablets could disintegrate uniformly within 3 min. Conclusion： The optimization of the prescription and preparation process parameters of Shengmai dispersing tablets is stable and reliable, and has good repeatability, and the process is feasible.

关 键 词：分散片 均匀设计 制备工艺 

分 类 号：R263.614[医药卫生—中医外科学]