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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 and quality evaluation of the traditional Chinese medicine Xiongxiong microemulsion. Methods: The optimum formulation of pseudo-ternary phase diagram was drawn by titration. The stability, particle size distribution and other properties of Xiongxiong microemulsion were investigated. The contents of ligustrazine and ferulic acid in microemulsion were determined by high performance liquid chromatography. Results: Xiongxiong microemulsion was stable in nature with uniform particle size distribution with average particle diameter of 17.6 nm. The concentration of ligustrazine in microemulsion was 2.6 g.L-1, the recovery was 97.0% and the RSD was 1.5% (n = 6). The concentration of ferulic acid was 0.3 g.L-1, the recovery was 95.9% and RSD was 1.9% (n = 6). Conclusion: The quality of Xiong Bing microemulsion is stable, the detection method is sensitive, accurate and reproducible.