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目的:研究不同加入量亲水性/疏水性纳米二氧化硅(nSiO2)对甘草次酸脂化乳稳定性的影响。方法:取甘草次酸脂化乳4 mL,分别加入0.5%、1.0%、1.5%(m/m,下同)亲水性nSiO2和0.4%、0.7%、1.0% 疏水性nSiO2,30 ℃水浴孵育2 h,同时以同批次甘草次酸脂化乳为空白对照。处理后在电镜下观察形态,并测定吸光度值,根据吸光度值计算稳定参数(KE);根据KE值对nSiO2的加入量进行优化,制备3批制剂进行验证试验。结果:电镜下观察,球形结构为甘草次酸脂化乳,包裹在其表面的白色环状(包裹完全)或半环状结构(未包裹完全)为nSiO2。加入0.5%、1.0%、1.5%亲水性nSiO2的产品KE分别为4.66%、5.01%、-2.08%,加入0.4%、0.7%、1.0% 疏水性nSiO2的产品KE分别为3.02%、4.51%、7.24%;优化的加入量为亲水性nSiO2 0.2%、0.3%、0.4%,疏水性nSiO2 0.1%、0.2%、0.3%,KE依次为6.19%、3.05%、7.84%,8.42%、2.41%、2.93%。最优加入量为0.3%亲水性nSiO2、0.2%疏水性nSiO2;验证试验中3批制剂均在此加入量时稳定性最佳。结论:亲水性或疏水性nSiO2均可提高甘草次酸脂化乳的稳定性,且以0.3%、0.2%加入量为佳。
OBJECTIVE: To study the effect of hydrophilic/hydrophobic nano-silica with different adding amount on the stability of lipo-emulsion. METHODS: Glycyrrhetinic acid lipo-emulsion 4 mL was taken, respectively adding into 0.5%, 1.0%, 1.5% (m/m, the same below) hydrophilic nSiO2, and 0.4%, 0.75, 1.0% hydrophobic nSiO2, incubating 2 h in 30 ℃ water; the same batch of Glycyrrhetinic acid lipo-emulsion was treated as blank control. The forms were observed under electron microscopy after treatment, absorbance value was determined, the stability parameter (KE) was calculated according to the absorbance value, then the adding amount of nSiO2 was optimized, 3 batches of preparations was prepared, and the verification test was conducted. RESULTS: The spherical structure was Glycyrrhetinic acid lipo-emulsion in the electron microscopy, the substance wrapping its surface white ring (fully wrapped) or semi-circular structure (not fully wrapped) was nSiO2. KE of hydrophilic nSiO2 were 4.66%, 5.01% and -2.08%, and KE of hydrophobic nSiO2 were 3.02%, 4.51% and 7.24%. The optimized adding amount of hydrophilic nSiO2 was 0.2%, 0.3% and 0.4%, hydrophobic nSiO2 was 0.1%, 0.2% and 0.3%; KE were 6.19%, 3.05%, 7.84%, 8.42%, 2.41%, 2.93%, respectively. The optimal adding amount was 0.3% hydrophilic nSiO2 and 0.2% hydrophobic nSiO2; the 3 batches of preparation showed the optimum stability in its own adding amount. CONCLUSIONS: Both hydrophilic and hydrophobic nSiO2 can improve the stability of Glycyrrhetinic acid lipo-emulsion, and preferably 0.3%, 0.2%.
纳米二氧化硅甘草次酸脂化乳稳定性亲水性疏水性
Nano-silicaLipo-emulsionStabilityHydrophilicityHydrophobicity
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