本文選題：葉黃素酯 + 納米粒�。� 參考：《中草藥》2017年14期

【摘要】：目的優(yōu)化葉黃素酯(LE)納米粒(NPs)的制備工藝,并對(duì)其水溶性的改善程度進(jìn)行測(cè)試。方法以四氫呋喃為溶劑,去離子水為反溶劑,泊洛沙姆188作為表面活性劑,通過反溶劑法制備LE-NPs,采用單因素實(shí)驗(yàn)設(shè)計(jì)法優(yōu)化LE-NPs制備工藝。并綜合利用掃描電子顯微鏡、激光粒度儀、X射線衍射、差示掃描量熱法等分析方法對(duì)獲得的LE-NPs理化性質(zhì)進(jìn)行表征;采用氣相色譜(GC)進(jìn)行溶劑殘留測(cè)定;并進(jìn)行了體外溶出對(duì)比實(shí)驗(yàn)。結(jié)果 LE-NPs的最優(yōu)制備條件為沉積時(shí)間10 min,葉黃素酯質(zhì)量濃度50 mg/mL,溶劑反溶劑體積比為1∶7,泊洛沙姆188質(zhì)量分?jǐn)?shù)0.5%,攪拌速率950 r/min,沉積溫度25℃;所得LE-NPs為球形,平均粒徑為164 nm,其中四氫呋喃殘留量為344.3μg/g,低于人用藥物注冊(cè)技術(shù)要求國(guó)際協(xié)調(diào)會(huì)(ICH)要求的最低標(biāo)準(zhǔn)(0.780 mg/g);在人工胃液環(huán)境中LE-NPs的飽和溶解度和溶出速率分別是原藥的2.91倍和9.65倍。結(jié)論反溶劑法制備的LE-NPs具有較好水溶性,在口服制劑中具有潛在的用途。
[Abstract]:Objective to optimize the preparation process of lutein Ester (LEL) nanoparticles (NPs) and to test the improvement of its water solubility. Methods LE-NPs were prepared by using tetrahydrofuran as solvent, deionized water as antisolvent and Poloxamer 188 as surfactant. The preparation process of LE-NPs was optimized by single factor experimental design. The physical and chemical properties of LE-NPs were characterized by scanning electron microscope (SEM), laser particle size analyzer (LE-NPs), X-ray diffraction (XRD) and differential scanning calorimetry (DSC). A comparative experiment of dissolution in vitro was carried out. Results the optimum preparation conditions of LE-NPs were as follows: deposition time 10 min, lutein ester concentration 50 mg / mL, solvent antisolvent volume ratio 1: 7, Poloxamer 188 mass fraction 0.5, stirring rate 950 rpm, deposition temperature 25 鈩，

本文編號(hào)：2045187