| 引用本文: | 栾妮,阮昊,石云峰,杨伟峰.图像数据化软件在仿制药体外溶出曲线一致性评价中的应用[J].中国现代应用药学,2017,34(1):78-80. |
| LUAN Ni,RUAN Hao,SHI Yunfeng,YANG Weifeng.Application of Graph Digitizer Software in the Consistency Evaluation of the Dissolution Curve of Generic Drugs in Vitro[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(1):78-80. |
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| 摘要: |
| 目的 利用图像数据化软件读取日本橙皮书中或FDA固体制剂溶出曲线数据库中溶出曲线数据，再用f2相似因子计算公式计算，用于国产仿制药与原研药的体外溶出曲线一致性评价的预试验。方法 按软件使用说明，设置坐标原点和纵坐标、横坐标最大值。利用截图软件获取参比制剂的溶出曲线图，保存为图像文件。确定溶出曲线上需要获取数据的点，经软件分析即可获得各个点的累积溶出量。再用f2相似因子计算公式计算，得到的f2值用于仿制药与参比制剂溶出曲线一致性判断。结果 以盐酸雷尼替丁片为例，通过图像分析软件可以获得日本橙皮书溶出数据库中参比制剂的累积溶出量数据，用于仿制药与参比制剂体外溶出曲线一致性评价的预试验。结论 图像分析软件可以通过数据化处理，得到文献上参比制剂的溶出量数据，用于仿制药体外溶出曲线一致性的预试验。 |
| 关键词: 一致性评价 溶出曲线 图像数据化软件 仿制药 f2相似因子 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.01.018 |
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| Application of Graph Digitizer Software in the Consistency Evaluation of the Dissolution Curve of Generic Drugs in Vitro |
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LUAN Ni1, RUAN Hao2, SHI Yunfeng2, YANG Weifeng1,2
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1.College of Chemical Engineering, Zhejiang University of Technology, Hangzhou 310014, China;2.Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
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| Abstract: |
| OBJECTIVE To get the data of dissolution curve in Japanese Orange Book or FDA solid oral dosage forms database by using the graph digitizer software. By similarity factor (f2) calculation, it can forecast consistency evaluation of dissolution curve between domestic generics and original research drug in vitro. METHODS According to the software instructions, set the value of the origin and the maximum value of the vertical coordinate and the horizontal coordinate. By screenshot software to obtain the figure of dissolution curve for reference preparation, saved as image files. The point on the dissolution curve was determined, then the cumulative dissolution data of each point could be obtained by software analysis. Calculate the f2 value using f2 similar factor calculation formula. The consistency of dissolution curve between generic drugs and reference preparation could be forecasted. RESULTS Through graph digitizer software to get dissolution data in Japanese orange book or FDA solid oral dosage forms database. Evaluate consistency of the dissolution curve in vitro between generic drugs and reference formulations. CONCLUSION The graph digitizer software can be used for data processing to get the dissolution curve data of the reference preparation in the literature, and it can be used to evaluate the consistency of the dissolution curve in vitro for generic drugs. |
| Key words: consistency evaluation dissolution curve graph digitizer software generic drugs similarity factor(f2) |
