| 苯磺酸氨氯地平口腔崩解片的工艺优选与含量测定 |
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| 引用本文： | 凌志敏,李娟,郭英球,曾翠梅.苯磺酸氨氯地平口腔崩解片的工艺优选与含量测定[J].中国医院药学杂志,2010(3). |
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| 作者姓名： | 凌志敏 李娟 郭英球 曾翠梅 |
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| 作者单位： | 广州中医药大学第三附属医院药剂科;湖南医药工业研究所; |
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| 摘 要： | 目的:优选苯磺酸氨氯地平口腔崩解片最佳制备工艺,并建立其含量测定方法。方法:以口感、崩解时限及溶出度为参数,采用正交设计法优化包衣颗粒与片芯处方,并采用HPLC法测定所制备样品的含量。结果:最佳处方为苯磺酸氨氯地平原料5.0g,甘露醇160g,聚维酮K301.0g,乙基纤维素20g,交联聚乙烯吡咯烷酮6.0g,阿斯巴甜2.0g,微粉硅胶2.0g,香橙香精2g,硬脂酸镁2g(制成1 000片)。苯磺酸氨氯地平进样量(μg)在0.203 6~2.036μg范围内与峰面积线性关系良好,平均回收率为99.16%,RSD为0.45%(n=9)。结论:处方设计合理,测定方法操作方便,结果准确,重复性好。
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| 关 键 词： | 苯磺酸氨氯地平 口腔崩解片 正交试验 崩解时限 含量测定 |
Preparation and quality control of amlodipine besylate oral rapidly disintegrating tablets |
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| LIN Zhi-min,LI Juan,GUO Ying-qiu,ZEN Cui-mei.Preparation and quality control of amlodipine besylate oral rapidly disintegrating tablets[J].Chinese Journal of Hospital Pharmacy,2010(3). |
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| Authors: | LIN Zhi-min LI Juan GUO Ying-qiu ZEN Cui-mei |
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| Institution: | LIN Zhi-min1,LI Juan2,GUO Ying-qiu2,ZEN Cui-mei1(1.The Third Affiliated Hospital to Guangzhou University of Traditional Chinese Medicine,Guangdong Guangzhou 510360,China,2.Hunan Institute of Pharmaceutical Industry,Guangdong Changsha 410014,China) |
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| Abstract: | OBJECTIVE To study the formula optimization and the content determination of amlodipine besylate oral disintegrating tablets.METHODS Based on the taste,disintegration time and dissolution of the product,to sieve the optimal formula and preparation procedure.The quantitative determination of amlodipine besylate was performed with HPLC method.RESULTS The optimal formula was as follows: amlodipine besylate 5.0 g,mannitol 160 g,povidone k30 1.0 g,ethyl cellulose 20 g,pvpp 6.0 g,aspartame 2.0 g,SiO2 2.0 g,orange... |
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| Keywords: | amlodipine besylate oral rapidly disintegrating tablets orthogonal design disintegration time content determination |
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