| 左乙拉西坦缓释片的制备及稳定性研究 |
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| 引用本文： | 何凤娟,肖衍宇,操锋,孙敏捷,平其能. 左乙拉西坦缓释片的制备及稳定性研究[J]. 药学进展, 2011, 35(10): 472-477 |
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| 作者姓名： | 何凤娟 肖衍宇 操锋 孙敏捷 平其能 |
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| 作者单位： | 中国药科大学药剂学教研室,江苏,南京,210009 |
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| 基金项目： | 国家重大新药创制科技重大专项 |
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| 摘 要： | 目的：制备抗癫痫药物左乙拉西坦的水凝胶骨架缓释片，并对其稳定性进行考察。方法：以羟丙甲基纤维素型号、用量、片剂制备方法和片剂硬度为考察因素，对左乙拉西坦缓释片的制备工艺进行优化，并以外观、增重、左乙拉西坦含量和释放度为指标对片剂在高湿度、高温和强光下的稳定性进行考察。结果：以K15M为骨架材料，左乙拉西坦与K15M的质量比为3：1，采用湿法制粒工艺，片剂硬度控制为16～17kg。该自制片剂在不同pH的释放介质中均有较好且相近的释放行为，片剂在高湿度条件下不稳定，热稳定性和光稳定性较好。结论：左乙拉西坦缓释片制备工艺简单易行，质量可控，符合大规模生产要求。
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| 关 键 词： | 左乙拉西坦 羟丙甲基纤维素 缓释片 稳定性 |
Study on Preparation and Stability of Levetiracetam Sustained-Release Tablets |
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| HE Feng-juan,XIAO Yan-yu,CAO Feng,SUN Min-jie,PING Qi-neng. Study on Preparation and Stability of Levetiracetam Sustained-Release Tablets[J]. Progress in Pharmaceutical Sciences, 2011, 35(10): 472-477 |
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| Authors: | HE Feng-juan XIAO Yan-yu CAO Feng SUN Min-jie PING Qi-neng |
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| Affiliation: | HE Feng-juan,XIAO Yan-yu,CAO Feng,SUN Min-jie,PING Qi-neng(Department of Pharmaceutics,China Pharmaceutical University,Nanjing 210009,China) |
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| Abstract: | Objective:To prepare the hydrogel-matrix sustained-release tablets of the antiepileptic drug levetiracetam(LEV),and to investigate the stability of the tablets.Methods:The preparation process of LEV sustained-release tablets was optimized by investigating the type and amount of hydroxypropylmethyl cellulose(HPMC),preparing methods,as well as the hardness of the tablets.The stability of the tablets was studied under different conditions,such as high humidity,high temperature and strong light exposure,by taki... |
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| Keywords: | levetiracetam hydroxypropyl methylcellulose sustained-release tablet stability |
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