灯盏花素缓释包衣微丸的制备工艺研究
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云南省药物研究所,云南昆明650111

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R2836

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基金项目:云南省科技厅新药研究开发专项计划(NO:2000XY10)收稿日期:2011—03—18修回日期:2011—07—07作者简介:孙敏(1971~),男,云南昆明人,工程师。研究方向:制剂工艺研究。△通讯作者:王京昆,Tel:0871-8411937-8003,E-mail:wjkyimm@163com。


Preparation of Breviscapine in Sustained-release Pellets
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Yunnan Institute of Materia Medica, Yunnan Kunming 650111,China

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    摘要:

    目的:制备灯盏花素缓释微丸,并对其体外释药情况进行研究。方法:以圆整度、收率、外观硬度为考察指标,筛选出灯盏花素载药丸芯适宜的充填剂辅料为微晶纤维素和乳糖,以L9(34)正交表筛选出最佳载药丸芯制备工艺,并在流化床内采用缓释包衣液对其进行包衣,制备灯盏花素缓释微丸。结果:筛选出的最佳工艺条件为A3B3C3,即30%的微晶纤维素、3min的滚圆时间、800rpm的滚圆机转速频率,采用以乙基纤维素(EC)为阻滞剂的缓释包衣液对微丸进行缓释膜控包衣,成功地制备了灯盏花素缓释微丸。结论:本工艺科学合理,制剂稳定,灯盏花素缓释微丸体外释药缓慢、持续、平稳。

    Abstract:

    Objective: To prepare breviscapine sustained-release pellets, and test its in vitro release. Methods: According to the spherical degree, yield, appearance hardness of the indexes, the microcrystalline cellulose and lactose were slected as the appropriate accessories of breviscapine drug-loaded pills, and L9 (34) orthogonal table was used to optimize the best drug-loaded pills preparation process.Then the pills were coated in liquid fluidized bed with sustained-release coating liquid. Breviscapine Sustained-release pellets were prepared. Results: The optimum conditions were screened out as A3B3C3, which was microcrystalline cellulose(30%), spheronization time(3minutes) and spheronization machine frequency (800rpm). The pellets were coated with sustained-release coating liquid in which ethyl cellulose (EC) was used as a blocker. Breviscapine Sustained-release pellets were successfully prepared. Conclusion: The process was scientific and rational.The preparation was stabale and in vitro release of breviscapine sustained-release pellets was slow, continuous and smooth.

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