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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
纸质出版日期:2011
移动端阅览
[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.
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。
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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