安神温胆丸质量标准的研究

Quality standard for Anshen Wendan Pill

目的:建立安神温胆丸(制半夏、陈皮、茯苓、人参等)的质量控制标准。方法:采用薄层色谱法对制剂中的陈皮、五味子、人参、甘草进行鉴别,用高效液相色谱法测定安神温胆丸中五味子醇甲和橙皮苷的含量。用滴定法测定朱砂中的硫化汞(HgS)含量。结果:在薄层色谱法中能够鉴别出陈皮、五味子、人参、甘草。五味子醇甲的进样量在0.017～0.52μg范围内成良好的线性,r=1.0000(n=5),平均回收率为99.83%,RSD=0.86%(n=6)。橙皮苷的进样量在0.506～2.53μg范围内成良好的线性,r=1.0000(n=5),平均回收率为100.43%,RSD=1.39%,(n=6)。朱砂的平均回收率为98.30%,RSD=1.06%,(n=6)。结论:该方法操作简便,准确可靠,重现性好,可用于控制安神温胆丸的质量。

AIM： To establish a quality standard for Anshen Wendan Pill（Rhizoma Pinelliae Praeparata, Pericarpium Citri reticulatae, Poria, Radix et Rhizoma Ginseng, etc. ）. METHODS： Pericarpium Citri Reticulatae, Fructus Schisandrae Chinensis, Radix et Rhizoma Ginseng, and Radix et Rhizoma Glycyrrhizae were identified by TLC, and the contents of schisandrin and hesperidin were determined by HPLC. The content of cinnabaris was determined by titration. RESULTS： Pericarpium Citri reticulatae, Fructus Schisandrae Chinensis, Radix et Rhizoma Ginseng, and Radix et Rhizoma Glycyrrhizae could be identified by TLC. The calibration curve of schisandrin was linear in the range of 0. 017-0.52 μg with the correlation coefficient of 1. 000 0 （ n = 5 ）. The average recovery of schisandrin was 99.83% （ RSD = 0.86%, n = 6 ）. The calibration curve of hesperidin was linear in the range 0. 506-2.53 μg, with the correlation coefficient of 1. 000 0 （ n = 5 ）. The average recovery hesperidin was 100.43% （RSD= 1. 39%, n = 6）. The average recovery of cinnabaris was 98. 30% （RSD = 1. 06%, n = 6）. CONCLUSION： The methods are simple, accurate and reproducible. They are suitable for the quality control of Anshen Wendan Pill.