星点设计-效应面法优化毛冬青分散片处方工艺

刘志刚; 李雪玲; 李沙沙; 刘莉; 翁立冬; 刘强; 朱红霞; 黄德浩; 黄志刚

doi:10.13422/j.cnki.syfjx.2015130013

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星点设计-效应面法优化毛冬青分散片处方工艺

药剂与炮制 | 更新时间：2024-01-04

- 星点设计-效应面法优化毛冬青分散片处方工艺
- Optimization of Preparation Technology of Maodongqing Dispersible Tablets by Central Composite Design-response Surface Methodology
- 中国实验方剂学杂志 2015年21卷第13期页码：13-15
- 作者机构：
- 作者简介：
- 基金信息：
  
  省部中药速效片剂产学研结合创新平台项目(2012B090600024)
- DOI：10.13422/j.cnki.syfjx.2015130013
  中图分类号： R283.6
- 纸质出版日期：2015
- 稿件说明：
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刘志刚, 李雪玲, 李沙沙, 等. 星点设计-效应面法优化毛冬青分散片处方工艺[J]. 中国实验方剂学杂志, 2015,21(13):13-15.

LIU Zhi-gang, LI Xue-ling, LI Sha-sha, et al. Optimization of Preparation Technology of Maodongqing Dispersible Tablets by Central Composite Design-response Surface Methodology[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(13): 13-15.
刘志刚, 李雪玲, 李沙沙, 等. 星点设计-效应面法优化毛冬青分散片处方工艺[J]. 中国实验方剂学杂志, 2015,21(13):13-15. DOI： 10.13422/j.cnki.syfjx.2015130013.

LIU Zhi-gang, LI Xue-ling, LI Sha-sha, et al. Optimization of Preparation Technology of Maodongqing Dispersible Tablets by Central Composite Design-response Surface Methodology[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(13): 13-15. DOI： 10.13422/j.cnki.syfjx.2015130013.

摘要

目的: 优选毛冬青分散片的处方工艺

为毛冬青的临床应用提供新选择。方法: 选择毛冬青醇提物为原料

采用单因素试验筛选填充剂、崩解剂及润湿剂;以崩解时限为因变量

采用星点设计-效应面法考察微晶纤维素(MCC)、交联聚维酮(PVPP)及羧甲基淀粉钠(CMS-Na)用量对毛冬青分散片处方工艺的影响。结果: 最佳工艺条件为毛冬青醇提物40%

磷酸氢钙27%

18% MCC

9%PVPP

5%CMS-Na

0.2%三氯蔗糖

3%聚维酮

0.8%硬脂酸镁。崩解时限84.7 s

与预测值的偏差3.3%。结论: 毛冬青分散片制备工艺简单、崩解时限短、制剂稳定性好

适合工业化生产。

Abstract

Objective: To optimize preparation process of Maodongqing dispersible tablets. Method: Taking alcohol extract of Ilex pubescens as raw material

fillers

disintegrating and wetting agent were screened by single factor test.With disintegration time linited as index

central composite design-response surface methodology was adopted to optimize formulation process by taking amouts of microcrystalline cellulose (MCC)

cross-linked povidone (PVPP) and sodium carboxymethyl starch (CMS-Na) as factors. Result: The best preparation process was as following:alcohol extract of 40%

calcium hydrogen phosphate of 27%

MCC of 18%

PVPP of 9%

CMS-Na of 5%

PVP of 3%

sucralose of 0.2%

magnesium stearate of 0.8%.disintegration time limited was 84.7 s

whose deviation was 3.3% by comparing with the predictive value. Conclusion: Preparation process of Maodongqing dispersible tablets is simple with short disintegration time limited and good preparation stability

which is suitable for industrial production.

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