氯沙坦钾片仿制药与原研药溶出曲线的相似性评价

发布时间：2018-05-16 10:50

  本文选题：氯沙坦钾片 + 仿制药　； 参考：《中国药房》2017年30期

【摘要】：目的:考察氯沙坦钾片仿制药与原研药溶出曲线的相似性,为完善该制剂的质量评价提供参考。方法:采用桨法,以盐酸溶液(pH 3.0)、磷酸盐缓冲液(pH 4.5)、磷酸盐缓冲液(pH 6.8)、水为溶出介质,溶出介质体积为900 mL,转速为50 r/min,进行溶出试验,采用紫外-可见分光光度法,检测波长为256 nm,分别测定氯沙坦钾片仿制药与原研药的累积溶出度,并通过计算相似因子(f2)来评价其溶出曲线的相似性。结果:氯沙坦钾检测质量浓度线性范围为12.11~35.96μg/mL(r≥0.999 7);精密度、稳定性、重复性试验的RSD5.0%;4种溶出介质中的回收率分别为98.66%~100.84%(RSD=0.77%,n=9)、98.91%~100.59%(RSD=0.49%,n=9)、98.33%~101.39%(RSD=0.85%,n=9)、99.46%~101.32%(RSD=0.55%,n=9)。在4种溶出介质中,3批氯沙坦钾片仿制药与原研药溶出曲线的f2均70。结论:氯沙坦钾片仿制药与原研药的体外溶出曲线相似性较好。
[Abstract]:Objective: to investigate the similarity between the dissolution curve of losartan potassium tablets and the original drug, and to provide reference for improving the quality evaluation of losartan potassium tablets. Methods: the dissolution test was carried out with hydrochloric acid solution (pH 3.0), phosphate buffer solution (pH 4.5), phosphate buffer solution (pH 6.8), water as dissolution medium, volume of dissolution medium being 900 mL and rotational speed of 50 rmin. The dissolution test was carried out by UV-Vis spectrophotometry. The detection wavelength was 256 nm. The cumulative dissolution of Losartan potassium tablets was determined, and the similarity of dissolution curve was evaluated by calculating the similarity factor. Results: the linear range for the determination of Losartan potassium was 12.11 卤35.96 渭 g/mL(r 鈮，

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