| 引用本文: | 任璐彤,周刚,高佳丽.呋塞米片原研药与仿制药溶出曲线的研究[J].中国现代应用药学,2020,37(14):1681-1686. |
| REN Lutong,ZHOU Gang,GAO Jiali.Research on Dissolution Curves of Generic and Original Furosemide Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(14):1681-1686. |
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| 摘要: |
| 目的 建立呋塞米体外溶出度曲线试验方法，进行原研药与仿制药的相似性评价，提高药品一致性。方法 绘制溶出度曲线研究原研药在不同溶出介质中的溶出情况，采用ƒ2因子法评价仿制药与原研药的相似性。结果 11种国产呋塞米片仿制药与参比制剂无法达到5条溶出曲线ƒ2因子均>50的要求。结论 呋塞米片仿制药与原研药5条溶出曲线相差甚多，不符合评价要求，提示国产仿制药在处方或工艺上亟需改进。 |
| 关键词: 呋塞米片 仿制药 原研药 溶出曲线 ƒ2因子 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.14.003 |
| 分类号:R927.1 |
| 基金项目:国家食品药品监督管理总局仿制药一致性评价研究项目（食药监办药化管[2013]38号） |
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| Research on Dissolution Curves of Generic and Original Furosemide Tablets |
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REN Lutong1, ZHOU Gang2, GAO Jiali3
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1.Inner Mongolia People's Hospital, Hohhot 010000, China;2.Inner Mongolia Institute of Pharmaceutical Inspection, Hohhot 010000, China;3.The Affiliated Hospital of Inner Mongolia Medical University, Hohhot 010000, China
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| Abstract: |
| OBJECTIVE To establish a method for the dissolution curves in vitro, evaluate the similarity between original and generic drugs, improve the consistency and the level of medical service. METHODS Draw the dissolution curve of the original drug research different dissolution conditions of medium. Used ƒ2factor method to evaluate generic and original drugs similarity. RESULTS Eleven domestic furosemide tablets and reference preparations could not meet the requirements of ƒ2 factors in 5 dissolution curves, all of which were >50. CONCLUSION There is a big difference between the dissolution curves of generic and the original furosemide tablets, which does not conform to evaluation requirements, suggesting that the formulation and production process of generic furosemide need to be improved. |
| Key words: furosemide tablets generics original dissolution curve ƒ2 factor |
