电导率-含水量曲线法研究以肉桂油为模型药物的O/W型微乳

Study on O/W-type microemulsion using cinnamon oil as model drug by conductivity-water content curve

目的采用电导率-含水量曲线法研究以肉桂油为模型药物的O/W型微乳。方法选取15个空白微乳处方建立电导率-含水量曲线,与目测法对比后,选取其中4个处方,分别建立以肉桂油为模型药物的O/W型微乳的电导率-含水量曲线,并进行方法学考察及质量评价。结果电导率-含水量曲线的顶点均为O/W型微乳成型的临界点,其值显著高于目测法测定的临界值,目测法所测定的O/W型微乳的临界值不准确,在双连续区域内,方法学试验的RSD均<1%,以肉桂油为模型药物与空白O/W型微乳的电导率-含水量曲线确定的临界含水量值进行比较,无统计学意义,4个含药微乳的平均粒径为46.22 nm,多分散系数为0.615,分布较均匀。结论所用方法精确、易量化、重复性好,能准确地反映微乳的相行为以及结构的变化。

OBJECTIVE To establish a conductivity-water content curve of O/W microemulsion using cinnamon oil as model drug.METHODS 15 prescriptions of blank microemulsion were used to establish the conductivity-water content curve.4 prescription of them were chosen out by comparision of visual method and conductivity-water content curves were established respectively.Meanwhile,methodological evaluation and quality assessment were conducted.RESULTS All the vertexes of conductivity-water content curves were critical points of O/W microemulsion forming,whose values were significantly higher than those determined by visual method.The critical points evaluated by visual method were not accurate,and the RSD were all less than 1% in double row area.It was not statistically significant in critical points tested with conductivity-water content curves established by cinnamon oil and blank O/W microemulsion.The average size of 4 drug-containing microemulsions was 46.22 nm with PDI of 0.615.The distribution of particles was uniform.CONCLUSION The method was quantitative,accurate and reproducible.It has both theoretical and practical feasibility.It can also accurately reflect the phase behavior and structural changes of microemulsion.