| 降糖片质量标准研究 |
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| 引用本文： | 吴志. 降糖片质量标准研究[J]. 辽宁中医药大学学报, 2012, 0(6): 220-221 |
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| 作者姓名： | 吴志 |
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| 作者单位： | 辽宁省人民医院 |
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| 摘 要： | 目的:建立降糖片质量控制标准。方法:采用高效液相法测定瑞格列奈的含量、含量均匀度和溶出度。结果:瑞格列奈质量浓度在0.0125~0.0625mg.mL-1,r=0.9998,范围内与峰面积呈良好线性关系,回收率为99.2%,RSD为1.6%(n=9),最低检测限为5.0ng,最低定量限为10.0ng,含量均匀度为5.56,45min累积溶出度为99.79%。结论:所建立降糖片的质量标准,符合相关要求。
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| 关 键 词： | 降糖片 HPLC 含量测定 质量标准 |
Preparation and Quality Standard of Jiangtang Tablets |
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| WU Zhi. Preparation and Quality Standard of Jiangtang Tablets[J]. Journal of Liaoning University of Traditional Chinese Medicine, 2012, 0(6): 220-221 |
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| Authors: | WU Zhi |
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| Affiliation: | WU Zhi(Liaoning Province People’s Hospital,Shenyang 110016,Liaoning,China) |
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| Abstract: | Objective:Establish the quality standard of Jiangtang tablets.Methods:HPLC method was established to measure content,content uniformity and dissolution rate.Results:A good linear relationship was obtained in the range of 0.0125~0.0625mg·mL-1,r=0.9998.The average recovery was 99.2%,with RSD 1.6%(n=9).The LOD was 5.0ng and the LOQ was10.0ng,content uniform was 5.56,and dissolution was 99.79%.Conclusion:The quality standard of Jiangtang tablets met the requirements. |
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| Keywords: | Jiangtang tablets HPLC content determination quality standard |
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