| 引用本文: | 柳晓蕊,章正赞,贺周扬,潘昕,吴传斌.克拉霉素缓释包衣微丸的制备及体外释放度研究[J].中国现代应用药学,2013,30(2):143-147. |
| LIU Xiaorui,ZHANG Zhengzan,HE Zhouyang,PAN Xin,WU Chuanbin.Preparation and in Vitro Release Study of Sustained-release Coated Pellets Containing Clarithromycin[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(2):143-147. |
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| 克拉霉素缓释包衣微丸的制备及体外释放度研究 |
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柳晓蕊1,2,3, 章正赞1,2, 贺周扬1,2, 潘昕1,2, 吴传斌1,2
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1.中山大学药学院，广州 510006;2.广东省创新药物制剂工程技术研究中心，广州 510006;3.广州医学院附属肿瘤医院，广州 510095
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| 摘要: |
| 目的 制备克拉霉素缓释包衣微丸，并对其体外释放度进行考察。方法 采用挤出滚圆技术制备克拉霉素含药微丸。以优化的丙烯酸树脂类Eudragit NE30D和Eudragit L30D-55混和水分散体为包衣材料，采用流化床包衣技术，制备缓释包衣微丸。考察自制缓释微丸的体外释药速率，并与市售的克拉霉素缓释胶囊进行比较。结果 通过释药行为的评价，得到优化的包衣处方为5∶1的Eudragit NE30D和Eudragit L30D-55混和包衣材料，其体外释放行为在不同的pH溶出介质中与市售制剂产品没有明显差异，体外释药过程符合一级释放模型。结论 采用挤出滚圆和流化床技术，以及优化的Eudragit NE30D和Eudragit L30D-55混和水分散体包衣材料，成功制备了克拉霉素缓释包衣微丸。 |
| 关键词: 克拉霉素 挤出滚圆 流化床 丙烯酸树脂 缓释包衣微丸 |
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| 基金项目:广东省创新药物制剂工程技术研究开发中心(2011B080100019) |
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| Preparation and in Vitro Release Study of Sustained-release Coated Pellets Containing Clarithromycin |
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LIU Xiaorui1,2,3, ZHANG Zhengzan1,2, HE Zhouyang1,2, PAN Xin1,2, WU Chuanbin1,2
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1.School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou 510006, China;2.Guangdong Research Center for Drug Delivery Systems, Guangzhou 510006, China;3.Guangzhou Medical University Cancer Institute and Hospital, Guangzhou 510095, China
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| Abstract: |
| OBJECTIVE To prepare sustained-release coated pellet containing clarithromycin, and to investigate its in vitro drug release behavior. METHODS Extrusion-spheronization technology was used to prepare clarithromycin-containing pellets. The drug contained pellets were coated with the optimized polymeric combination of Eudragit NE30D and Eudragit L30D-55 by using fluid-bed technology. In vitro drug release behavior of the coated pellets was studied and compared with the commercially available sustained-release capsules of clarithromycin. RESULTS There were no significant differences in different pH dissolution medium between the coated pellets and commercial products in drug release behavior, with optimized coating material as Eudragit NE30D and Eudragit L30D-55 at ratio of 5∶1. The drug release mechanism of coated pellets was in accordance with first-order release model. CONCLUSIONS With extrusion- spheronization and fluid-bed technology, the sustained-release coated pellets containing clarithromycin are successfully prepared by using the mixture aqueous dispersion of Eudragit NE30D and Eudragit L30D-55 as coating material. |
| Key words: clarithromycin extrusion-spheronization fluid-bed Eudragit sustained-release coated pellets |
