今日药学

2017, v.27(03) 153-157

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复方盐酸二甲双胍格列美脲双释胶囊的研制
Preparation of Metformin Hydrochloride/Glimepiride Double Release Capsules

刘秀,可成友
LIU Xiu,KE Chengyou

摘要(Abstract):

目的制备盐酸二甲双胍肠溶缓释微丸和格列美脲速释颗粒,并研制复方双释胶囊,考查其溶出行为。方法挤出滚圆法制备盐酸二甲双胍丸芯,采用薄膜包衣法对丸芯进行包衣,固体分散体技术制备格列美脲速释颗粒,分别考查两种药物制剂的溶出行为。结果盐酸二甲双胍肠溶缓释微丸在酸中2 h几乎不释放,溶出度小于5%,而且在p H6.8的介质中释放缓慢,12 h释放基本完全;格列美脲速释颗粒在20 min可释放完全。结论复方盐酸二甲双胍格列美脲胶囊具有双释放效果,使两种药物产生协同作用,提高患者的顺应性。
OBJECTIVE To prepare metformin hydrochloride enteric sustained-release pellets and glimepiride quick release particles. To develop compound double release capsules and evaluate the dissolution behaviors. METHODS Metformin hydrochloride sustained-release pellets were prepared by extrusion-spheronisation and the method of thin film coating was used. Glimepiride quick release granules were prepared by solid dispersions techniques. The dissolution was investigated respectively. RESULTS The metformin hydrochloride enteric sustained-release pellets were almost not release in the acid after 2 h,and the dissolution was less than5%. The pellets released slowly and released completely after 12 h in the medium of p H6. 8. Glimepiride particles were released completely in 20 min. CONCLUSION Metformin hydrochloride/glimepiride compound capsules have double release effect. The capsules showed synergistic effect and the patients' compliance can be improved.

关键词(KeyWords): 盐酸二甲双胍;格列美脲;固体分散体;挤出滚圆;薄膜包衣
metformin hydrochloride;glimepiride;solid dispersions;extrusion-spheronisation;thin film coating

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作者(Author): 刘秀,可成友
LIU Xiu,KE Chengyou

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