二次回归正交旋转组合设计法对元胡止痛口崩片处方的优化  

Optimization of Formulation of Yuanhuzhitong Orally Disintegrating Tablets by Quadratic Regression Orthogonal Rotation Combination Design

作　　者：王文忠[1] 罗亚珊[1] 张立娜[1] 郑平[1] 

机构地区：[1]天津市食品生物技术重点实验室天津商业大学生物技术与食品科学学院,天津300134

出　　处：《现代中药研究与实践》2012年第1期53-55,共3页Research and Practice on Chinese Medicines

摘　　要：摘要：目的优化元胡止痛口崩片处方。方法以口崩片的崩解时限为评价指标，采用二次回归正交旋转组合设计方法筛选元胡止痛口崩片最优处方。结果优化处方为微晶纤维素78％，交联羧甲基纤维素钠4．5％，硬脂酸镁0．1％，柠檬酸4％，桔子香精2％，甜蜜素1％和乳糖9．45％。元胡止痛口崩片硬度为3．5-4．5kg，崩解时限少于1min。结论该口崩片具有一定的硬度，崩解时限符合要求，且口感良好。Objective To optimize the formulation of Yuanhuzhitong orally disintegrating tablets. Methods With disintegration time as an index, the optimal formulation was obtained by quadratic regression orthogonal rotation combination design. Results The best formulation was as follows： microcrystalline cellulose 78%, cross-linked sodium carboxymethyl cellulose 4.5%, magnesium stearate 0.1%, citric acid 4%, orange flavor 2%, sodium cyclamate 1%, lactose 9.45%. The tensile strength was 3.5 - 4.5kg, and the disintegration time was less than lmin. Conclusion The disintegration time and tensile strength of Yuanhuzhitong orally disintegrating tablets were better and the taste was satisfactory.

关 键 词：元胡止痛口崩片 处方 优化 二次回归正交旋转组合设计 

分 类 号：R944.4[医药卫生—药剂学]