本文選題：馬來酸羅托沙敏　切入點(diǎn)：緩釋混懸液　出處：《中國藥房》2017年07期 　論文類型：期刊論文

【摘要】：目的:制備馬來酸羅托沙敏緩釋混懸液并評(píng)價(jià)其質(zhì)量。方法:以馬來酸羅托沙敏為原料,采用陽離子交換樹脂制備載藥樹脂;并通過表面包衣法,以Eudragit RS100為包衣材料制備緩釋微粒,最終制成緩釋混懸液。采用高效液相色譜法測定馬來酸羅托沙敏的含量,計(jì)算載藥量,比較原研制劑與自制混懸液的釋放度。結(jié)果:載藥樹脂制備時(shí)藥物用量為2%、反應(yīng)溫度為25℃、反應(yīng)時(shí)間為4 h,表面包衣時(shí)載藥量為35%、包衣材料的用量為10%、反應(yīng)溫度為40℃。緩釋微粒包衣前、后的載藥量分別為35.23%和32.72%,收率為96.82%;所制緩釋混懸液中馬來酸羅托沙敏占標(biāo)示量的98.76%,10 h的累積釋放度達(dá)80%左右,與原研制劑比較的相似因子f2為65.73。結(jié)論:成功制得馬來酸羅托沙敏緩釋混懸液,其釋放特性與原研制劑相似。
[Abstract]:Objective: to prepare rotorsalamine maleate sustained-release suspension and evaluate its quality. Methods: using rotorsalamine maleate as raw material, cationic exchange resin was used to prepare drug-carrying resin, and drug carrying resin was prepared by surface coating method. Eudragit RS100 was used as coating material to prepare slow-release particles, and finally sustained release suspension was prepared. The content of rotosamine maleate was determined by high performance liquid chromatography (HPLC), and the amount of drug loaded was calculated. Results: the amount of drug used in the preparation of drug-loaded resin was 2%, and the reaction temperature was 25 鈩，

本文編號(hào)：1628534