| 基于相似系统理论的溶出曲线相似性评价方法 |
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| 引用本文： | 邓祖磊,洪秋菊,崔田,刘大护.基于相似系统理论的溶出曲线相似性评价方法[J].中国医药工业杂志,2020(3):393-395. |
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| 作者姓名： | 邓祖磊 洪秋菊 崔田 刘大护 |
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| 作者单位： | 蚌埠市食品药品检验中心;兰州职业技术学院生物工程系;甘肃西北医药有限公司 |
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| 摘 要： | 本研究将相似系统理论应用于固体制剂溶出曲线的相似性评价,提出以再次改良的程度相似度(Q')作为仿制制剂和参比制剂溶出曲线相似性评价的指标,并推荐判断为相似的标准为Q'值不小于85。分别采用本法对文献数据进行计算,并与报道的相似因子(similarity factor,?2)法比较。结果表明,2种方法的评价结果一致,因此本法可用于评价固体制剂溶出曲线的相似性,并且本法可避免相似因子法的一些不足之处。
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| 关 键 词： | 相似理论 固体制剂 溶出曲线 程度相似度 相似性评价 |
Evaluation Method of Dissolution Similarity Based on Similarity System Theory |
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| Authors: | DENG Zulei HONG Qiuju CUI Tian LIU Dahu |
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| Affiliation: | (The Food and Drug Inspection Center of Bengbu,Bengbu 233000;Dept.of Bio-engineering,Lanzhou Vocational Technical College,Lanzhou 730070;Gansu Northwest Medical&Parmaceutical Co.,Ltd.,Lanzhou 730070) |
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| Abstract: | A method for evaluating dissolution similarity of solid preparations was established based on the similarity system theory.A re-improved extent similarity(Q')was calculated as an index to evaluate the similarity of dissolution curves between the genetic and reference preparations,and the judgment criterion for similarity was recommended that the value of Q'should be no less than 85.This method was used to calculate Q'values based on the literature data and compared with the reported similarity factor(?2)method.The results showed that the evaluation results of both methods were consistent,indicating the feasibility of this method for similarity evaluation.Moreover,this method could avoid some of the shortcomings of the similarity factor method. |
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| Keywords: | similarity system theory solid preparation dissolution curve extent similarity similarity evaluation |
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