论文部分内容阅读
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f_2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f_2相似因子计算公式计算,得到的f_2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。
OBJECTIVE To calculate the dissolution curve of dissolution curve in Japanese Orange Book or FDA solid dosage form using image data software and then calculate the f_2 similarity factor formula to evaluate the in vitro dissolution curve of domestic generic drug and original drug Pre-test. Method According to the software instructions, set the coordinate origin and ordinate, abscissa maximum. Use the screenshot software to get the dissolution profile of the reference formulation and save it as an image file. Determine the dissolution curve of the need to obtain data point, the software analysis can be obtained at each point of the cumulative dissolution. Then f_2 similarity factor calculation formula, the f_2 value obtained for generic drug and reference preparation dissolution curve consistency judgment. Results Using Ranitidine Hydrochloride as an example, the cumulative dissolution data of reference preparations in Japanese Orange Book Dissolution Database can be obtained by image analysis software, which is used for the pre-test of in vitro dissolution profiles of generic drugs and reference preparations . Conclusion The image analysis software can obtain the reference sample dissolution data in the literature through data processing and is used for the pre-test of in vitro dissolution curve of generic drugs.