2)法對釋放曲線的相似性進(jìn)行評價(jià)。結(jié)果 當(dāng)托拉塞米質(zhì)量濃度在1.0~12.0 μg/mL時(shí),其質(zhì)量濃度與峰面積呈現(xiàn)良好的線性關(guān)系(r=0.999 5);精密度試驗(yàn)、溶液穩(wěn)定性試驗(yàn)良好,供試液色譜峰峰面積的相對標(biāo)準(zhǔn)偏差均小于2.0%;準(zhǔn)確度試驗(yàn)平均回收率為100.04%,相對標(biāo)準(zhǔn)偏差為0.54%(n=12);自制片的批內(nèi)均一性符合技術(shù)要求,6個(gè)溶出杯內(nèi)各取樣點(diǎn)的相對標(biāo)準(zhǔn)偏差均<10%;托拉塞米緩釋自制片與原研制劑在5種不同的釋放介質(zhì)中f2因子分別為72、60、77、66、60。結(jié)論 本文所建立方法可用于托拉塞米緩釋片釋放度的檢測,托拉塞米緩釋片自制產(chǎn)品與原研產(chǎn)品體外釋放行為一致。;Objective To establish a method for determining the dissolution of torasemide sustained-release tablet in vitro and study the methodology of the determination. The consistency of the in vitro release behavior between self-prepared torasemide sustained-release tablet and original preparation were evaluated by constructed method.Methods HPLC method was applied to detect the cumulative release percentage of self-prepared torasemide sustained-release tablet and original preparation in five kinds of release media (water, 0.1 mol/L hydrochloric acid solution, pH 4.5 acetate buffer, pH 6.8 phosphate buffer, and 0.1 mol/L hydrochloric acid solution turn to pH 6.8 phosphate buffer). Similarity factor (f2) was used to evaluate the similarity of release curves.Results There was a good linear relationship between the quality concentration of torasemide and peak area in the range of 1.0-12.0 μg/mL (r=0.999 5).Results of precision and stability tests were good, and the RSDs for probational liquid were all lower than 2.0%. The average recovery of accuracy test was 100.04%, and RSD was 0.54% (n=12). The homogeneity of within group of self-prepared preparation met the technical requirement, RSDs of each sampling points in six Dissolution Vessels were lower than 10.0%. The f2 factors of self-prepared torasemide sustained-release tablet and original preparation were 72, 60, 77, 66, and 60 in five kinds of release media.Conclusion The method in the paper is suitable for the release test of torasemide, meanwhile, the self-prepared tablet shows consistent in vitro release behavior with that of the original preparation."/>

醉酒后少妇被疯狂内射视频,一本色道久久综合一,在线天堂新版资源www在线下载,中文字幕乱人伦高清视频,中字幕视频在线永久在线观看免费

首頁 > 過刊瀏覽>2017年第40卷第2期 >2017,40(2):174-178. DOI:10.7501/j.issn.1674-6376.2017.02.006
上一篇 | 下一篇

自制與原研托拉塞米緩釋片體外釋放行為的一致性評價(jià)

Study on in vitro release consistency between self-prepared Torasemide Sustained-Release Tablet and original preparation

發(fā)布日期:2017-02-17
您是第位訪問者
藥物評價(jià)研究 ® 2025 版權(quán)所有
技術(shù)支持:北京勤云科技發(fā)展有限公司
津備案:津ICP備13000267號 互聯(lián)網(wǎng)藥品信息服務(wù)資格證書編號:(津)-非經(jīng)營性-2015-0031