Preparation of Ginkgolide Sustained-Release Tablets

JIN Miao-miao1; GUO Qing-ming2; JIANG Ming1; SU Xiao-feng2; CHEN Teng-fei1; XIAO Wei2

doi:10.13422/j.cnki.syfjx.2011.05.001

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Preparation of Ginkgolide Sustained-Release Tablets

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- Preparation of Ginkgolide Sustained-Release Tablets
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 17, Issue 5, Pages: 12-16(2011)
- 作者机构：
  
  1. 南京中医药大学
  2. 中药制药过程新技术国家重点实验室(筹)
  3. 江苏康缘药业股份有限公司
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.2011.05.001
  CLC： TQ461
- Published：2011
- 稿件说明：
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[1]晋苗苗,郭庆明,蒋鸣,苏晓峰,陈腾飞,萧伟.银杏内酯缓释片的制备工艺筛选及体外释放度评价[J].中国实验方剂学杂志,2011,17(05):12-16.

JIN Miao-miao1, GUO Qing-ming2, JIANG Ming1, et al. Preparation of Ginkgolide Sustained-Release Tablets[J]. Chinese journal of experimental traditional medical formulae, 2011, 17(5): 12-16.
[1]晋苗苗,郭庆明,蒋鸣,苏晓峰,陈腾飞,萧伟.银杏内酯缓释片的制备工艺筛选及体外释放度评价[J].中国实验方剂学杂志,2011,17(05):12-16. DOI： 10.13422/j.cnki.syfjx.2011.05.001.

JIN Miao-miao1, GUO Qing-ming2, JIANG Ming1, et al. Preparation of Ginkgolide Sustained-Release Tablets[J]. Chinese journal of experimental traditional medical formulae, 2011, 17(5): 12-16. DOI： 10.13422/j.cnki.syfjx.2011.05.001.

摘要

目的:研究银杏内酯缓释片的制备方法

并考察其体外释放特性。方法:以银杏内酯A（GA）和银杏内酯B（GB）释放度为考察指标

采用单因素试验法

考察了羟丙基甲基纤维素（HPMC）不同规格及用量

乳糖用量、低取代羟丙基纤维素（L-HPC）、羧甲基淀粉钠（CMS-Na）的用量对药物体外释放行为的影响

并采用正交设计实验对处方进行优化

确定最佳制备工艺条件。结果:以羟丙基甲基纤维素（HPMCK4M）为骨架材料

低取代羟丙基纤维素（L-HPC）为崩解剂

微晶纤维素和乳糖为填充剂

制备了每天给药1次的银杏内酯缓释片。该制剂2 h释放约30%

6 h释放约60%

12 h释放90%以上

满足缓释片释放要求。结论:本方法制备的银杏内酯缓释片外观及可压性良好

具有良好的释放性能。且工艺简单易行

生产成本低。

Abstract

Objective:To study the method of preparing ginkgolides sustained-release tablets and investigate its vitro release characteristics.Method:the release of ginkgolides A（GA） and ginkgolides B（GB） was used as indicators to evaluate and optimize the formulation.The effets of hydroxypropyl methyl cellulose（HPMC） type and amount

the lactose amount

low-substituted hydroxypropyl cellulose（L-HPC） amount and carboxymethyl starch sodium（CMS-Na） amount on release behavior in vitro were observed in single-factor testing method.Then the formula-tion was optimized by orthogonal design test to determine the best preparation technological conditions.Result:The sustained-release tablets which were taken once a day

were prepared with HPMCK4M as matrix

low-substituted hydroxypropyl cellulose as disintegrant

microcrystalline cellulose and lactose as fillers.The tablets released 30% in 2 h

60% in 6 h

and exceeding 90% in 12 h

meeting the requirements for sustained-release.Conclusion:Ginkgolides sustained-release tablets prepared in this method has good behavior of release characteristics.The shape of tablets and compressibility were good.The preparative technology is also simple with low producing cost.

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