| 阿仑膦酸钠肠溶片的质量和稳定性研究 |
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| 引用本文： | 曹雯,张育,孙勇兵,刘艳,孙进,何仲贵.阿仑膦酸钠肠溶片的质量和稳定性研究[J].中国医药导报,2010,7(21):53-56. |
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| 作者姓名： | 曹雯 张育 孙勇兵 刘艳 孙进 何仲贵 |
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| 作者单位： | 1. 沈阳药科大学药学院,辽宁沈阳,110016
2. 石药集团欧意药业有限公司,河北石家庄,050051 |
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| 基金项目： | 国家"重大新药创制"石药集团创新药物研制产学研联盟建设项目 |
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| 摘 要： | 目的：对阿仑膦酸钠肠溶片进行质量和稳定性研究。方法：采用比色法测定阿仑膦酸钠,对阿仑膦酸钠肠溶片中主药含量、释放度和稳定性进行了考察。结果：阿仑膦酸钠肠溶片在模拟胃液中2h不释放,在模拟肠液（pH=6.8）中45min释放度大于标示量的80%,且同一批次内和不同批次间的释放度均一性良好,药物含量符合《中国药典》规定,稳定性实验表明样品质量均未见明显改变,暂定本品有效期为2年。结论：阿仑膦酸钠肠溶片的含量均匀,释放度重现性良好且产品稳定性好。
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| 关 键 词： | 阿仑膦酸钠 肠溶片 质量研究 稳定性 |
Quality control and stability research of Enteric-coated alendronate sodium Tablets |
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| CAO Wen,ZHANG yu,SUN Yongbing,LIU Yan,SUN Jin,HE Zhonggui.Quality control and stability research of Enteric-coated alendronate sodium Tablets[J].China Medical Herald,2010,7(21):53-56. |
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| Authors: | CAO Wen ZHANG yu SUN Yongbing LIU Yan SUN Jin HE Zhonggui |
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| Institution: | 1.School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;2.Shiyao Ouyi Pharmacutical Co.,Ltd.,Shijiazhuang 050051,China) |
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| Abstract: | Objective：To study the quality and stability of Enteric-coated alendronate sodium Tablets.Methods：The colorimetric method was used to determine the quality of the Tablets,including the contents,the release percentage and the stability.Results：The Enteric-coated alendronate sodium Tablets（70 mg/tablet） did not release in simulated gastric fluid for 2 h and the cumulative release was beyond 80% in simulated intestinal juice for 45 min.Homogeneity of release in a same batch or between different batches was fine.Meanwhile,the drug content met the pharmacopoeia requirements too.The results of stability experiment showed that the drug was stable in 2 years.Conclusion：The content uniformity,the reproducibility of release and the stability of the Enteric-coated alendronate sodium Tablets is well. |
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| Keywords: | Alendronate sodium Enteric-coated Tablets Quality research Stability |
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