| 8种格列美脲片剂的质量比较 |
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| 引用本文： | 朱全刚,潘勇华,樊毅,尤本明,刘继勇,高申.8种格列美脲片剂的质量比较[J].中国临床药学杂志,2012(1):33-37. |
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| 作者姓名： | 朱全刚 潘勇华 樊毅 尤本明 刘继勇 高申 |
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| 作者单位： | [1]第二军医大学长海医院药学部,上海200433 [2]新疆军区乌鲁木齐综合仓库,乌鲁木齐830002 |
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| 摘 要： | 目的比较8种格列美脲片之间的质量差异,为临床用药提供参考。方法依据2010版《中华人民共和国药典(二部)》附录中方法对不同厂家片剂的重量差异、崩解时限、含量均匀度、溶出度以及有关物质等进行检查,采用HPLC法测定格列美脲及其有关物质格列美脲磺酰胺、格列美脲氨基甲酸酯的含量。结果 8种格列美脲片剂的重量差异均在±4%内,崩解时限均<15 min,有关物质与含量均匀度均符合质量标准规定,但溶出度差异存在统计学意义。结论不同厂家格列美脲片剂质量之间存在一定的差异。
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| 关 键 词： | 格列美脲 质量 反相高效液相色谱法 |
Comparison of the quality of eight glimepiride tablets |
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| ZHU Quangang,PAN Yonghua,FAN Yi,YOU Benming,LIU Jiyong,GAO Shen.Comparison of the quality of eight glimepiride tablets[J].Chinese Journal of Clinical Pharmacy,2012(1):33-37. |
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| Authors: | ZHU Quangang PAN Yonghua FAN Yi YOU Benming LIU Jiyong GAO Shen |
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| Institution: | 1 Department of Pharmacy, Changhai Hospital, The Second Military Medical University, Shanghai 200433, China ; 2 Urumqi General Warehouse, Xinjiang Military District, Urumqi 830002, China) |
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| Abstract: | AIM To compare the quality of eight glimepiride tablets for clinical reference in drug choice. METHODS According to the methods in the appendix of Chinese Pharmacopoeia 2010 （Part II ）, weight variation,disintegration time, content uniformity, dissolution and related substance of glimepiride tablets from different manufactures were in- spected. The contents of glimepiride and its related substances glimepiride sulfonamide and carbamate glimepiride were determined by RP-HPLC. RESULTS Weight variation of eight glimepiride tablets were within ±4%, disintegration time were less than 15 min, related substance and content uniformity were conformable to quality standards. However, dissolution of glimepiride tablets from different manufactures showed more significant differences. CONCLUSION There are certain differences in qualities of glimepiride tablets from different manufactures. |
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| Keywords: | glimepiride quality RP-HPLC |
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