芎冰微乳的制备及质量评价

Preparation of Xiongbing microemulsion and its quality evaluation

目的:研究中药复方芎冰微乳的制备和质量评价方法。方法:采用滴定法绘制伪三元相图优选处方;考察芎冰微乳的稳定性、粒径分布等特性;高效液相色谱法测定微乳中川芎嗪、阿魏酸的含量。结果:芎冰微乳性质稳定,粒径分布均匀,平均粒径17.6 nm。微乳中川芎嗪质量浓度2.6 g.L-1,回收率97.0%,RSD 1.5%(n=6);阿魏酸质量浓度0.3 g.L-1,回收率95.9%,RSD 1.9%(n=6)。结论:芎冰微乳质量稳定,检测方法灵敏,准确,重复性好。

Objective： To study the preparation of XIONG-BING microemulsion（XB ME）and its quality evaluation.Method： XB ME was prepared by using the methods of titration to prepare the Pseudo-ternary phase diagram.The stability and size distribution of XB ME were tested.The contents of TMP and FA in ME were determined by HPLC method.Result： The character of XB ME was stable.The average diameter was 17.6 nm,and a uniform distribution of particle size were achieved.The solubility of TMP in ME was 2.6 g·L^-1,the methodological average recovery was 97.0% with RSD of 1.5%（n=6）;The solubility of FA in ME was 0.3 g·L^-1,the methodological average recovery was 95.9% with RSD of 1.9%（n=6）.Conclusion： The results indicated that the quality of XB ME was stable.The method to determine the contents of TMP and FA was accurate and reliable.