| 盐酸青藤碱单室单层渗透泵型控释片的制备及释放考察 |
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| 引用本文： | 辛伟,张志宏,白敏,梁敏,杨敏. 盐酸青藤碱单室单层渗透泵型控释片的制备及释放考察[J]. 中国药学杂志, 2011, 46(19): 1500-1505 |
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| 作者姓名： | 辛伟 张志宏 白敏 梁敏 杨敏 |
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| 作者单位： | 石药集团中奇制药技术(石家庄)有限公司; |
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| 基金项目： | 科技部“十一五”重大新药创制项目(2009zx09503-026); 中国药物技术创新及产业化战略联盟,科技部“十一五”重大新药创制(2010ZX09401-402) |
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| 摘 要： | 目的 研制盐酸青藤碱单室渗透泵型控释片，并考察体外释药行为。方法 采用湿法制粒制备片芯，包衣后激光打孔制备渗透泵片。考察不同辅料种类及用量、助溶剂及包衣增重等因素对药物释放的影响。考察优选处方在不同溶出条件下的释药行为。结果 渗透泵片片芯采用质量百分比为60% 的甘露醇-乳糖（2∶1）为渗透促进剂，10%酒石酸为酸性助溶剂；包衣膜采用醋酸纤维素为控释材料，聚乙二醇为增塑剂，包衣增重4%。所得控释片可体外控制释药16 h，药物释放曲线符合零级释药模型。结论 所研制的盐酸青藤碱控释片释药过程达到了预期的控释目的。
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| 关 键 词： | 盐酸青藤碱 单室单层渗透泵片 |
| 收稿时间： | 2012-01-01; |
Preparation of Monolithic Sinomenine Hydrochloride Osmotic Pump Tablets and Dissolution Test |
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| XIN Wei,ZHANG Zhi-hong,BAI Min,LIANG Min,YANG Min Shijiazhuang co.,LTD,Shijiazhuang ,China. Preparation of Monolithic Sinomenine Hydrochloride Osmotic Pump Tablets and Dissolution Test[J]. Chinese Pharmaceutical Journal, 2011, 46(19): 1500-1505 |
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| Authors: | XIN Wei ZHANG Zhi-hong BAI Min LIANG Min YANG Min Shijiazhuang co. LTD Shijiazhuang China |
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| Affiliation: | XIN Wei,ZHANG Zhi-hong,BAI Min,LIANG Min,YANG Min Shijiazhuang co.,LTD,Shijiazhuang 050051,China |
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| Abstract: | OBJECTIVE To develope monolithic sinomenine hydrochloride osmotic pump tablets and study the drug release behavior.METHODS Sinomenine hydrochloride and core excipients were mixed well,and granules were prepared using wet-granulation method.Then the granules were compressed into tablets and coated by pan coating.Orifice was formed by laser.The influence of different types and amount of excipients,solubilizers and coating amounts on drug release were studied.The dissolution of optimized formulation in differe... |
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| Keywords: | sinomenine hydrochloride monolithic osmotic pump tablet controlled release orthogonal design |
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