| 盐酸曲马多缓释微丸的制备及处方工艺考察 |
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| 引用本文： | 李霞,刘晓军,马桂芝,鲁燕侠. 盐酸曲马多缓释微丸的制备及处方工艺考察[J]. 解放军药学学报, 2007, 23(3): 187-190 |
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| 作者姓名： | 李霞 刘晓军 马桂芝 鲁燕侠 |
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| 作者单位： | 武警总医院,药剂科,北京,100039;解放军第325医院,妇产科,青海,西宁,810008 |
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| 摘 要： | 目的 制备日服2次的盐酸曲马多缓释微丸.方法 选用Eudragit NE 30D作为包衣缓释材料,采用Glatt流化床底喷溶液上药法制备载药微丸,并进行缓释包衣.结果 所制得的缓释微丸在1、4、8 h的释放率分别为标示量的30%～33%,60%～66%和80%～83%,药物的释放行为符合中国药典2005版对该缓释制剂释放度的相关规定.结论 本研究工艺简便,重现性良好,有望进行工业化生产.
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| 关 键 词： | 盐酸曲马多 Eudragit NE 30D 缓释微丸 释放度 |
| 文章编号： | 1008-9926（2007）03-0187-04 |
| 修稿时间： | 2007-04-192007-05-09 |
Preparation of Tramadol Hydrochloride Sustained Release Pellets |
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| LI Xia,LIU Xiao-Jun,MA Gui-Zi,LU Yan-Xia. Preparation of Tramadol Hydrochloride Sustained Release Pellets[J]. Pharmaceutical Journal of Chinese People's Liberation Army, 2007, 23(3): 187-190 |
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| Authors: | LI Xia LIU Xiao-Jun MA Gui-Zi LU Yan-Xia |
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| Affiliation: | 1.Pharmacy Department General Hospital of Armed Police, Beijing 100039 China;2.Department of obstetrice and gynecology, the Hospital 325 of PLA Xinin 810008, Qinghai China |
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| Abstract: | Aim To prepare twice-daily Tramadol hydrochloride sustained release pellets. Methods Eudragit NE 30D was chosen as the sustained coating material and GPCG 1 fluid bed with the Wurster insert was adopted to layer water solutions of the model drug and the sustained coating formula on MCC pellets in succession. Results At the predetermined time intervals, the accumulated release percent of the pellets was as 30% - 33 % ,60% -66% , 80% -83% and above 83% respectively, which met the related requirements of the release percentage in the Chinese Pharmacopeias 2005 edition. Conclusion The established process and formula were simple and reproducible, which was promising for scale-up production. |
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| Keywords: | Tramadol hydrochloride Eudragit NE 30D Sustained release pellets Release percent |
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