| 多条溶出曲线评价缬沙坦氨氯地平片的质量 |
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| 引用本文： | 陆步实,孙磊,周立新,董萱,孙川,卢定强.多条溶出曲线评价缬沙坦氨氯地平片的质量[J].中国医院药学杂志,2012(9):704-707. |
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| 作者姓名： | 陆步实 孙磊 周立新 董萱 孙川 卢定强 |
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| 作者单位： | 南京工业大学江苏省药物研究所有限公司;南京工业大学生物与制药工程学院;南京中医药大学药学院 |
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| 摘 要： | 目的:以国外上市的缬沙坦氨氯地平片作为参比制剂,考察自研制剂和参比制剂在不同pH的溶出介质中体外溶出行为的相似性。方法:通过测定2种制剂中氨氯地平和缬沙坦的溶出曲线,采用f2相似因子对溶出曲线的相似度进行评价。结果:在不同pH的溶出介质中,自研制剂中氨氯地平和缬沙坦的溶出曲线与参比制剂比较,f2相似因子均大于50。结论:自研制剂和参比制剂在不同pH的溶出介质中的体外溶出行为相似。
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| 关 键 词： | 缬沙坦 氨氯地平 溶出曲线 f2相似因子 |
Evaluation of the quality of valsartan and amlodipine tablets by dissolution curve in different mediums |
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| LU Bu-shi,SUN Lei,ZHOU Li-xin,DONG Xuan,SUN Chuan,LU Ding-qiang.Evaluation of the quality of valsartan and amlodipine tablets by dissolution curve in different mediums[J].Chinese Journal of Hospital Pharmacy,2012(9):704-707. |
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| Authors: | LU Bu-shi SUN Lei ZHOU Li-xin DONG Xuan SUN Chuan LU Ding-qiang |
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| Institution: | 1(1.Jiangsu Provincial Institute of Material Medica,Nanjing University of Technology,Jiangsu Nanjing 210009,China;2.School of Biotechnology and Pharmaceutical Engineering,Nanjing University of Technology,Jiangsu Nanjing 210009,China;3.Nanjing University of Chinese Medicine,Jiangsu Nanjing 210046,China) |
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| Abstract: | OBJECTIVE To investigate the dissolution behavior similarity between the reference preparation tablets(the listed in abroad valsartan and amlodipine tablets) and self-prepared(domestic) preparation in dissolution mediums with different pH.METHODS Through determining the dissolution curve of two preparations,then f2 similarity factor was used to evaluate the similarity of dissolution curves.RESULTS In different dissolution mediums,the dissolution curves of valsartan and amlodipine from self-prepared preparation compared with reference preparation,the similar factor(f2) were all more than 50.CONCLUSION The dissolution behavior of self-prepared preparation and reference preparation were similar in dissolution mediums with different pH. |
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| Keywords: | valsartan amlodipine dissolution curve f2 similarity factor |
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