人参皂苷-Rg3微乳剂的制备及其质量评价

研究人参皂苷-Rg3微乳剂的制备方法及其质量评价.选用聚山梨醇酯(80)及大豆卵磷脂作为表面活性剂,乙醇、异丙醇和丙二醇作为助表面活性剂,大豆色拉油、十四酸异丙酯作为油相,在制备伪三元相图的基础上,考察微乳中各组分及其用量比例对人参皂苷-Rg3增溶量的影响,筛选较为适宜的伪三元相图单相微乳区并按其配方制备人参皂苷-Rg3微乳剂.采用RP-HPLC、透射电镜等检测技术对其微乳剂的主要质量指标进行测定.伪三元相图研究结果表明,在卵磷脂-异丙醇-十四酸异丙酯-水微乳体系中,当Km=3/1时,形成的微乳区面积最小;Km=2/1时,形成的微乳区面积最大;其它比例形成的微乳区面积无明显差异.在聚山梨醇酯(80)-异丙醇-十四酸异丙酯-水微乳体系中,所选的4个不同Km值形成的微乳区面积无明显差异.表面活性剂和助表面活性剂的种类及其用量比例对人参皂苷-Rg3增溶量均有一定程度的影响,按所筛选配方制备的人参皂苷-Rg3微乳剂的主要质量指标达到要求.

Study on the Preparation of Microemulsion Ginsenoside-Rg3 and Its Quality Evaluation

To study the preparation of microemulsion ginsenoside-Rg3 and its quality evaluation,Tween-80 and lecithin were selected as surfactants,using alcohol,iso-propyl alcohol and propylene glycol as cosurfactants,and soybean salad oil and iso-proyl myristate as oil phase.On the basis of the triangular phase diagrams,each component and proportion in microemulsion on the concentration of ginsenoside-Rg3 were investigated.RP-HPLC and TEM were chosen to determine the main quality indicators of microemulsion.The results show that the area of the microemulsion was the smallest when the Km value was three,the area of the microemulsion was the largest when the Km value was two,but in the areas of the microemulsion there was no significant difference compared with other forms of Km in lecithin/iso-Propylalcohol/IPM/water system.Four different Km value were chosen in Tween-80/iso-Propylalcohol/IPM/water.The areas of the microemulsion showed no significant difference.The type and amount of surfactant and cosurfactants all impacted the solubility of ginsenoside-Rg3.The main quality indicators of microemulsion ginsenoside-Rg3 met the requirements.The ginsenoside-Rg3 microemulsion delivery could be prepared using lecithin/iso-Propylalcohol/IPM/water system.A new formulation for ginsenoside-Rg3 was developed.