Optimization of Formulation Technology for Kangfuxin Gastric Floating Tablets by Mixture Design

LI Yuan-hui; FENG Jian-an; WU Ya-xiao; WU Ying; WANG Huan; LI Xi

doi:10.13422/j.cnki.syfjx.2015060025

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Optimization of Formulation Technology for Kangfuxin Gastric Floating Tablets by Mixture Design

更新时间：2024-01-04

- Optimization of Formulation Technology for Kangfuxin Gastric Floating Tablets by Mixture Design
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 21, Issue 6, Pages: 25-28(2015)
- 作者机构：
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- DOI：10.13422/j.cnki.syfjx.2015060025
  CLC： R283.6
- Published：2015
- 稿件说明：
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LI Yuan-hui, FENG Jian-an, WU Ya-xiao, et al. Optimization of Formulation Technology for Kangfuxin Gastric Floating Tablets by Mixture Design[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(6): 25-28.
DOI：

LI Yuan-hui, FENG Jian-an, WU Ya-xiao, et al. Optimization of Formulation Technology for Kangfuxin Gastric Floating Tablets by Mixture Design[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(6): 25-28. DOI： 10.13422/j.cnki.syfjx.2015060025.

摘要

目的: 优选康复新胃漂浮片的处方

为康复新的开发利用提供参考。方法: 采用全粉末直接压片法制备康复新胃漂浮片

以体外漂浮性能与释药性能为综合评价指标

在单因素试验基础上

采用混料设计考察羟丙甲基纤维素(HPMC)、交联聚维酮(PVPP)及NaHCO3对康复新胃漂浮片处方的影响。利用HPLC测定氨基酸含量

流动相[0.1 mol ·L-1乙酸钠缓冲溶液(pH 6.5)-乙腈(93:7)]-[乙腈-水(80:20)]梯度洗脱

检测波长254 nm

柱温40 ℃。结果: 最佳处方为25%康复新冻干粉

28.38% HPMC K4M

13.38% NaHCO3

18.24% PVPP

14%微晶纤维素

1%硬脂酸镁。康复新胃漂浮片的起漂时间(2±0.2) min

持漂时间>12 h

体外释放符合零级动力学模型。结论: 制备的康复新胃漂浮片具有良好的体外漂浮性能和释药性能

可增加康复新在胃部的滞留时间

对治疗消化性溃疡具有重要意义。

Abstract

Objective: To optimize formula of Kangfuxin gastric floating tablets and provide a reference for development and utilization of Kangfuxin. Method: Kangfuxin gastric floating tablets were prepared by direct powder compression method.With in vitro floating properties and release as indexes

based on single factor tests

mixture design were adopted to optimize formula by taking dosages of hydroxypropyl methyl cellulose(HPMC)

crosslinking povidone(PVPP) and NaHCO3 as factors.HPLC was used to determine the content of amino acids with [0.1 mol · L-1 sodium acetate buffer solution(pH 6.5)-acetonitrile(93:7)]-[acetonitrile-water(80:20)]as mobile phase for gradient elution

detection wavelength of 254 nm and column temperature at 40 ℃. Result: Optimum formulation included 25% freeze-dried powder of Kangfuxin

28.38% HPMC K4M

13.38% NaHCO3

18.24% PVPP

14% microcrystalline cellulose and 1% magnesium stearate.Kangfuxin gastric floating tablets could float within (2±0.2) min and maintain for over 12 h

in vitro release of this tablets fitted zero-order kinetics model. Conclusion: These prepared gastric floating tablets show a good sustained-release and continual floating property

residence time of Kangfuxin in the stomach increases

it has great significance for treatment of peptic ulcer.

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