本文選題：酒石酸美托洛爾片 + 溶出曲線��； 參考：《中國藥房》2017年09期

【摘要】：目的:建立酒石酸美托洛爾片的溶出度測定方法,并評價仿制藥與原研藥的質(zhì)量一致性。方法:采用槳法,轉(zhuǎn)速為50r/min,分別以p H 1.2鹽酸溶液、p H 4.5醋酸鹽緩沖液和p H 6.8磷酸鹽緩沖液為溶出介質(zhì),用光纖藥物溶出度實時測定儀以10 mm的測定光程,分別測定酒石酸美托洛爾片仿制藥與原研藥的溶出曲線,并采用相似因子(f~2)法評價二者溶出曲線的相似性。結(jié)果:在3種溶出介質(zhì)中,酒石酸美托洛爾片仿制藥與原研藥的f2分別為80.5、66.8、69.4,說明二者溶出曲線具有相似性。結(jié)論:所建立的實時溶出度過程分析方法適用于酒石酸美托洛爾片的溶出度測定;仿制藥與原研藥的體外溶出行為具有相似性,故其質(zhì)量一致性較好。
[Abstract]:Objective: to establish a method for determination of dissolution of metoprolol tartrate tablets and to evaluate the quality consistency between generic and original drugs. Methods: the propeller method was used, the rotation speed was 50 r / min, the pH 4.5 acetate buffer solution and the pH 6.8 phosphate buffer solution were used as the dissolution media, and the optical path was measured by 10 mm optical fiber real time instrument. The dissolution curves of metoprolol tartrate tablets were determined and the similarity of dissolution curves was evaluated by similarity factor (ff2) method. Results: the f2 values of metoprolol tartrate tablets in three kinds of dissolution media were 80.5 and 66.8% respectively, which indicated that the dissolution curves were similar between the two kinds of tablets. The results showed that the dissolution curve of metoprolol tartrate tablets was similar to that of metoprolol tartrate tablets. Conclusion: the established real-time dissolution process analysis method is suitable for the determination of dissolution of metoprolol tartrate tablets.
【作者單位】： 新疆生產(chǎn)建設(shè)兵團(tuán)醫(yī)院藥學(xué)部;新疆醫(yī)科大學(xué)中心實驗室;
【基金】：新疆生產(chǎn)建設(shè)兵團(tuán)衛(wèi)生局科技項目(No.兵衛(wèi)發(fā)〔2014〕58號)
【分類號】：R927.2

【參考文獻(xiàn)】

相關(guān)期刊論文 前4條

1 王淑靜;張國良;王剛;呂響;;酒石酸美托洛爾片溶出度曲線的研究[J];中國現(xiàn)代藥物應(yīng)用;2015年05期

2 張明s，

本文編號：2094635