| 利培酮口溶膜剂的制备及质量评价 |
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| 引用本文： | 吴小玉,常娱,常学军. 利培酮口溶膜剂的制备及质量评价[J]. 中国医院药学杂志, 2017, 37(22): 2251-2254. DOI: 10.13286/j.cnki.chinhosppharmacyj.2017.22.09 |
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| 作者姓名： | 吴小玉 常娱 常学军 |
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| 作者单位： | 1. 武汉华夏理工学院, 湖北 武汉 430223;2. 湖北唯森制药有限公司, 湖北 鄂州 436070 |
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| 摘 要： | 目的：制备利培酮口溶膜剂，并评价其质量。方法：采用流延法制备利培酮口溶膜，以成膜性、外观形状、溶化时限为指标，筛选优化处方。结果：以枸橼酸为稳定剂、羟丙甲基纤维素E15为成膜材料、微晶纤维素和麦芽糊精为填充剂的膜剂可在30 s内溶化，与国外上市产品Risperidon Sandoz® Solufilm的溶化时限一致，自制样品与国外上市产品在体外4种介质中的溶出行为基本一致，5 min内基本释放完全。结论：利培酮可溶膜处方工艺合理。
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| 关 键 词： | 利培酮 口溶膜剂 流延法 处方工艺 溶出度 |
| 收稿时间： | 2016-12-15 |
Preparation and quality evaluation of risperidone oral soluble films |
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| WU Xiao-yu,CHANG Yu,CHANG Xue-jun. Preparation and quality evaluation of risperidone oral soluble films[J]. Chinese Journal of Hospital Pharmacy, 2017, 37(22): 2251-2254. DOI: 10.13286/j.cnki.chinhosppharmacyj.2017.22.09 |
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| Authors: | WU Xiao-yu CHANG Yu CHANG Xue-jun |
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| Affiliation: | 1. Wuhan Huaxia College of Technology, Hubei Wuhan 430223, China;2. Hubei Weisen Pharmaceutical Co., Ltd., Hubei Ezhou 436070, China |
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| Abstract: | OBJECTIVE To prepare risperidone oral soluble films and evaluate its quality.METHODS Risperidone oral soluble films were prepared by solvent casting technique. The formulation was optimized with films forming, appearance shape and melting time.RESULTS The product was prepared with citric acid as stabilizer, hydroxypropyl methyl cellulose E15 as membrane material, microcrystalline cellulose and maltodextrin as fillers. The test films could dissolve within 30 seconds and showed similar dissolution behaviors as those of imported Risperidon Sandoz® Solufil in 4 media in vitro. The basic release of the test sample was complete in 5 minutes.CONCLUSION The formulation and preparation of risperidone oral soluble films are reasonable. |
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