ABSTRACT
OBJECTIVE:To study the effect of hydrophilic/hydrophobic nano-silica with different adding amount on the stabili-ty 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. RE-SULTS:The spherical structure was Glycyrrhetinic acid lipo-emulsion in the electron microscopy,the substance wrapping its sur-face 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%.
ABSTRACT
OBJECTIVE:To provide reference indexs for the quality evaluation of Glycyrrhetinic acid lipo-emul. METHODS:Croy-TEM was used to detect the morphology of Glycyrrhetinic acid lipo-emul,laser nano-particle size analyzer was used to deter-mine the particle size,polydispersity index(PDI)and the zeta potential;UPLC was used to determine the drug loading of its ac-tive ingredient glycyrrhetinic acid;placing 10 d in 30 ℃,then stability was detected. RESULTS:Prepared Glycyrrhetinic acid li-po-emul was clear outline,structural integrity,roundlike and arranged closely;the mean particle size was(245.2±4.29)nm,PDI was (0.054 ± 0.01) and the mean zeta potential was (-6.25 ± 0.54) mV;the average drug loading of glycyrrhetinic acid was (1.25±0.09)mg/mL;the sample with mass concentration of 0.82 mg/mL showed good stability in within 10 d. CONCLUSIONS:Particle size,zeta potential,drug loading and stability can be used as the evaluation index of Glycyrrhetinic acid lipo-emul.