雙氯芬酸鈉淀粉微球的制備及其質(zhì)量評(píng)價(jià)
發(fā)布時(shí)間:2018-05-03 19:29
本文選題:雙氯芬酸鈉 + 淀粉微球 ; 參考:《中國(guó)藥學(xué)雜志》2016年07期
【摘要】:目的以可溶性淀粉為原料,N,N'-亞甲基雙丙烯酰胺為交聯(lián)劑,雙氯芬酸鈉為主藥,通過反相乳化交聯(lián)法制備雙氯芬酸鈉載藥淀粉微球。方法以微球平均粒徑和包封率為指標(biāo),采用單因素及正交實(shí)驗(yàn)優(yōu)化微球的處方和制備工藝。采用光學(xué)顯微鏡、透射電鏡、紅外光譜儀及差熱分析儀對(duì)所獲微球的外觀和結(jié)構(gòu)進(jìn)行表征,并通過透析法對(duì)載藥微球的體外釋藥情況進(jìn)行考察。結(jié)果經(jīng)正交實(shí)驗(yàn)優(yōu)化后的制備條件為:淀粉濃度10%,交聯(lián)溫度55℃,交聯(lián)劑用量0.2 g,油水體積比5∶1,乳化劑用量5 m L,交聯(lián)時(shí)間60 min,此條件制得的淀粉微球平均粒徑為9μm,形狀近球形,包封率為67.52%。紅外光譜和差熱分析表明淀粉已發(fā)生交聯(lián)。結(jié)論載藥淀粉微球具有較好的緩釋作用,藥物的體外釋放符合Weibull方程。
[Abstract]:Objective to prepare diclofenac sodium loaded starch microspheres by reverse phase emulsification and crosslinking with soluble starch as raw material and diclofenac sodium as crosslinking agent and diclofenac sodium as crosslinking agent. Methods the formulation and preparation process of the microspheres were optimized by single factor and orthogonal experiment, based on the average particle size and encapsulation efficiency of the microspheres. The appearance and structure of the microspheres were characterized by optical microscope, transmission electron microscope, infrared spectrometer and differential thermal analyzer, and the drug release in vitro was investigated by dialysis. Results the optimized preparation conditions were as follows: starch concentration was 10, crosslinking temperature was 55 鈩,
本文編號(hào):1839784
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