Optimization of Formulation Process of Ginkgo Folium Bi-layer Osmotic Pump Controlled-release Tablets by Central Composite Design-response Surface Methodology

CHEN Yan; GUO Ying-xin; YANG Xing-gang

doi:10.13422/j.cnki.syfjx.2015050020

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Optimization of Formulation Process of Ginkgo Folium Bi-layer Osmotic Pump Controlled-release Tablets by Central Composite Design-response Surface Methodology

更新时间：2024-01-04

- Optimization of Formulation Process of Ginkgo Folium Bi-layer Osmotic Pump Controlled-release Tablets by Central Composite Design-response Surface Methodology
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 21, Issue 5, Pages: 20-24(2015)
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- DOI：10.13422/j.cnki.syfjx.2015050020
  CLC： R283.6
- Published：2015
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CHEN Yan, GUO Ying-xin, YANG Xing-gang. Optimization of Formulation Process of Ginkgo Folium Bi-layer Osmotic Pump Controlled-release Tablets by Central Composite Design-response Surface Methodology[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(5): 20-24.
DOI：

CHEN Yan, GUO Ying-xin, YANG Xing-gang. Optimization of Formulation Process of Ginkgo Folium Bi-layer Osmotic Pump Controlled-release Tablets by Central Composite Design-response Surface Methodology[J]. Chinese journal of experimental traditional medical formulae, 2015, 21(5): 20-24. DOI： 10.13422/j.cnki.syfjx.2015050020.

摘要

目的: 优选银杏叶双层渗透泵控释片的处方工艺

为改善该制剂的临床用药安全性和有效性提供参考。方法: 以总黄酮醇苷的累积释放率为评价指标

通过单因素试验筛选含药层、助推层和包衣液处方

利用f2相似因子法进行相似性判断。选择包衣液中PEG4000用量、包衣增重及助推层PEO用量为自变量

药物释放曲线的相关系数和16 h内累积释放率为因变量

采用星点设计-效应面法优选银杏叶双层渗透泵控释片的处方。结果: 最优处方为助推层中聚氧乙烯120 mg

包衣液聚乙二醇4000用量1.5 g

包衣增重11%;16 h内累积释放率>90%。结论: 制备的渗透泵控释制剂释放曲线符合要求

线性良好(r=0.996 4)。优选的处方工艺稳定可行

可推广于银杏叶双层渗透泵控释片的工业化生产。

Abstract

Objective: To optimize formulation of Ginkgo Folium bi-layer osmotic pump controlled-release tablets. Method: With accumulative release rate of total flavonol glycosides as index

single-factor tests were adopted to screen formulations of drug-layer

push-layer and coating solution

drug release behavior was evaluated by similarity factor method.Taking the amount of PEG4000 in coating solution

coating weight and the amount of polyoxyethylene in push-layer as independent variables

linearity of release curve and accumulative drug release in 16 h as dependent variables

central composite design-response surface methodology was applied to optimize formulation. Result: Optimum formula was as follows:polyoxyethylene amount of 120 mg

the amount of PEG4000 of 1.5 g

coating weight of 11%;accumulative release of total flavonol glycosides in 16 h was above 90%. Conclusion: Release curve of this preparation meets requirements with correlation coefficient of 0.996 4.This optimized formulation is stable and suitable for industrial production of Ginkgo Folium bi-layer osmotic pump controlled-release tablets.

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