本文關(guān)鍵詞： HH-V-01片 質(zhì)量研究 質(zhì)量標(biāo)準(zhǔn) 生物等效性　出處：《浙江大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

【摘要】：本課題建立和驗(yàn)證了 HH-V-01片質(zhì)量研究分析方法,并用于自研HH-V-01片和原研DIOVAN片的比較研究,完成了兩者的藥學(xué)一致性和生物等效評(píng)價(jià)。1..HH-V-01片分析方法的開發(fā)與驗(yàn)證為了研究HH-V-01片的質(zhì)量,建立并驗(yàn)證了其溶出度試驗(yàn)、雜質(zhì)檢查和含量測(cè)定的分析方法。溶出度檢查:采用1000mL溶出介質(zhì),漿法75rpm轉(zhuǎn)速,經(jīng)30min時(shí),從每個(gè)溶出杯中通過自動(dòng)取樣器抽取10mL的供試品溶液,將該供試品溶液用10μm的過濾頭過濾,取續(xù)濾液采用紫外分光光度法(UV),于250nm進(jìn)行測(cè)定。有關(guān)物質(zhì)檢查:HPLC流動(dòng)相:乙腈:純化水:乙酸=450:550:1.1,十八烷基鍵合硅膠為填充劑,流速1.OmL/min,柱溫30℃,UV檢測(cè)器檢測(cè)波長(zhǎng)230 nm,進(jìn)樣量50μL。含量測(cè)定:HPLC條件與"有關(guān)物質(zhì)檢查"相同,UV檢測(cè)器檢測(cè)波長(zhǎng)250 nm,進(jìn)樣量20μL。2.HH-V-01片的質(zhì)量研究采用建立的分析方法,通過與原料藥和原研產(chǎn)品外觀性狀、溶出曲線和有關(guān)物質(zhì)的對(duì)照分析,對(duì)自研產(chǎn)品物理化學(xué)性質(zhì)和質(zhì)量進(jìn)行了全面研究。確定采用pH4.5醋酸鹽介質(zhì)作為本品的質(zhì)控介質(zhì)(溶出介質(zhì)體積1000mL,漿法75rpm,限度為30min溶出不得小于75%)。自研產(chǎn)品在制劑過程中原料藥晶型沒有改變,無(wú)特殊的降解產(chǎn)物,與原研產(chǎn)品具有藥學(xué)等效性。3.HH-V-01片規(guī)�；a(chǎn)樣品的質(zhì)量研究對(duì)中試驗(yàn)證樣品進(jìn)行了全分析,通過性狀、含量、有關(guān)物質(zhì)、溶出曲線考察、刻痕試驗(yàn),全面證明了 HH-V-01片與原研產(chǎn)品DIOVAN的質(zhì)量一致性。在空腹?fàn)顟B(tài)下,采用隨機(jī)開放、兩治療組、雙序列、雙周期、單次給藥雙交叉設(shè)計(jì)的方法在健康成人受試者中,口服等劑量HH-V-01片和DIOVAN進(jìn)行生物等效性試驗(yàn),結(jié)果顯示:自研HH-V-01片的藥物代謝動(dòng)力學(xué)參數(shù)Cmax、AUC0-t和AUC0-INF的90%置信區(qū)間在生物等效性可接受范圍80.00～125.00%內(nèi),即兩者具有生物等效性。
[Abstract]:This paper establishes and verifies the method of quality research and analysis of HH-V-01, and applies it to the comparative study of self-made HH-V-01 and original DIOVAN. In order to study the quality of HH-V-01 tablets, the dissolution test was established and verified. Determination of impurity and determination of content. Dissolution test: 1 000 mL dissolution medium, 75 rpm rotational speed of slurry method, after 30 min. 10 mL sample solution was extracted from each dissolution cup by automatic sampler. The sample solution was filtered with a filter head of 10 渭 m, and the continuous filtrate was extracted by UV spectrophotometry (UV). The related substances were determined at 250nm. The mobile phase consisted of acetonitrile: purified water: acetic acid 450: 550: 1.1, 18 alkyl bonded silica gel as filler. The flow rate was 1. OmL / min, the detection wavelength of UV detector was 230 nm at 30 鈩，

本文編號(hào)：1480587