本文選題：氯沙坦鉀片 + 仿制藥　； 參考：《中國藥房》2017年30期

【摘要】：目的:考察氯沙坦鉀片仿制藥與原研藥溶出曲線的相似性,為完善該制劑的質量評價提供參考。方法:采用槳法,以鹽酸溶液(pH 3.0)、磷酸鹽緩沖液(pH 4.5)、磷酸鹽緩沖液(pH 6.8)、水為溶出介質,溶出介質體積為900 mL,轉速為50 r/min,進行溶出試驗,采用紫外-可見分光光度法,檢測波長為256 nm,分別測定氯沙坦鉀片仿制藥與原研藥的累積溶出度,并通過計算相似因子(f2)來評價其溶出曲線的相似性。結果:氯沙坦鉀檢測質量濃度線性范圍為12.11~35.96μg/mL(r≥0.999 7);精密度、穩(wěn)定性、重復性試驗的RSD5.0%;4種溶出介質中的回收率分別為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種溶出介質中,3批氯沙坦鉀片仿制藥與原研藥溶出曲線的f2均70。結論:氯沙坦鉀片仿制藥與原研藥的體外溶出曲線相似性較好。
[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 鹵35.96 渭 g/mL(r 鈮，

本文編號：1896540