本文選題：硫辛酸 + 緩釋固體分散體��； 參考：《中國(guó)新藥雜志》2017年14期

【摘要】：目的:制備硫辛酸緩釋固體分散體,延長(zhǎng)藥物的釋放時(shí)間,提高其生物利用度。方法:利用機(jī)械化學(xué)技術(shù),結(jié)合微環(huán)境pH調(diào)控技術(shù),制備出硫辛酸緩釋固體分散體;并對(duì)制備條件及其體外釋放度的影響進(jìn)行分析,采用X射線衍射(XRD)技術(shù)對(duì)緩釋固體分散體進(jìn)行表征。結(jié)果:不同型號(hào)的乙基纖維素及其用量對(duì)緩釋固體分散體的釋放度有一定的影響,綜合考慮,乙基纖維素-N50(EC-N50)的效果較好;羥丙基甲基纖維素E3(HPMC-E3)對(duì)釋放度的調(diào)節(jié)效果最好;加入不同的堿化劑做作為pH調(diào)節(jié)劑對(duì)釋放度的影響也不盡相同,其中Na_2CO_3能使得釋放度在12 h內(nèi)釋放95%以上,藥物基本呈一級(jí)釋放。對(duì)機(jī)械球磨工藝進(jìn)行優(yōu)化,確定最佳的球磨工藝為球磨轉(zhuǎn)速100 r·min~(-1),球磨時(shí)間1 h。XRD技術(shù)證明固體分散體的形成。結(jié)論:以乙基纖維素為載體,采用固體分散技術(shù)結(jié)合微環(huán)境p H調(diào)控技術(shù)制備的硫辛酸緩釋固體分散體的緩釋效果明顯。
[Abstract]:Aim: to prepare the sustained-release solid dispersion of lipoic acid, prolong the release time and improve its bioavailability. Methods: the sustained release solid dispersion of lipoic acid was prepared by using mechanochemical technology and microenvironment pH control technique, and the effects of preparation conditions and in vitro release rate were analyzed. The sustained release solid dispersion was characterized by X ray diffraction (XRD). Results: different types of ethyl cellulose and its dosage had certain influence on the release rate of sustained release solid dispersion. Considering synthetically, the effect of ethyl cellulose-N50 EC-N50) was better than that of hydroxypropyl methyl cellulose E3HPMC-E3), and the effect of E3HPMC-E3) was the best. The effect of adding different alkali agent as pH regulator on the release was different. Na_2CO_3 could release more than 95% of the release within 12 h, and the drug was basically first-order release. The mechanical ball milling process was optimized. The optimum ball milling technology was determined to be the ball milling speed of 100r / min ~ (-1) and the milling time of 1 h.XRD to prove the formation of the solid dispersion. Conclusion: using ethyl cellulose as carrier and solid dispersion technology combined with microenvironment pH regulation technology, the sustained release effect of lipoic acid slow-release solid dispersion is obvious.
【作者單位】： 浙江工業(yè)大學(xué)藥學(xué)院;長(zhǎng)三角綠色制藥協(xié)同中心;
【分類號(hào)】：R943

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本文編號(hào)：1965373