| 引用本文: | 辛伟,张素娟,杨丽霞,梁敏,张志宏.伏立康唑片的制备及其质量评价[J].中国现代应用药学,2013,30(2):151-154. |
| XIN Wei,ZHANG Sujuan,YANG Lixia,LIANG Min,ZHANG Zhihong.Preparation and Evaluation of Voriconazole Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(2):151-154. |
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| 摘要: |
| 目的 制备并评价伏立康唑片。方法 采用预胶化淀粉、一水乳糖、交联羧甲基纤维素钠、聚维酮、硬脂酸镁制备伏立康唑片，并对其进行薄膜包衣。采用正交设计法确定最佳处方。对其硬度、脆碎度和溶出度进行考察并与市售伏立康唑片比较。结果 预胶化淀粉、一水乳糖、交联羧甲基纤维素钠、硬脂酸镁的用量分别为片重的40%，21%，3%和1%，采用5%聚维酮K90水溶液做黏合剂，片芯硬度为15 kg·cm-2，包衣厚度为4%左右时，伏立康唑片的溶出度接近原研产品。结论 伏立康唑片的制备工艺简单，重现性好，药物的溶出行为达到预期目的。 |
| 关键词: 伏立康唑片 制备工艺 正交设计 溶出度 |
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| 基金项目:科技部“十一五”重大新药创制(2011ZX09401-306) |
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| Preparation and Evaluation of Voriconazole Tablets |
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XIN Wei, ZHANG Sujuan, YANG Lixia, LIANG Min, ZHANG Zhihong
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CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co.,LTD, Shijiazhuang 050035, China
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| Abstract: |
| OBJECTIVE To prepare and evaluate voriconazole tablets. METHODS The inactive ingredients of voriconazole tablets include pregelatinized starch, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate. The tablets were film coated. The formulation of the tablets was optimized by an orthogonal design. The hardness, friability and dissolution behavior of the voriconazole tablets was examined and compared with the commercial products. RESULTS The voriconazole tablets contained 40% pregelatinized starch, 21% lactose monohydrate, 3% croscarmellose sodium and 1% magnesium stearate with 5% PVP K90 solution as binder. The hardness was about 15 kg·cm-2 and the coating level was 4%. The dissolution behavior of the voriconazole tablets was similar to the original products. CONCLUSION The process of preparation is feasible. The in vitro dissolution property of the voriconazole tablets was satisfactory. |
| Key words: voriconazole tablets process of preparation orthogonal design dissolution |
