三草安神胶囊的质量标准

Quality Standard for Sancao Anshen Capsules

目的:建立三草安神胶囊的质量标准。方法:采用TLC法对三草安神胶囊中缬草、夏枯草、黄芩、黄连进行定性鉴别;采用HPLC法对三草安神胶囊中的迷迭香酸进行定量分析。色谱柱:Hypersil ODS2 C18(250 mm×4.6 mm,5μm),流动相为乙腈(A)-0.1%三氟乙酸(B)(30∶70),等度洗脱,流速:1.0 ml·min^(-1),柱温:25℃,检测波长:330 nm,进样量:20μl。结果:TLC鉴别色谱中斑点清晰,阴性无干扰;迷迭香酸进样量在0.105~2.104μg(r=0.999 3)范围内线性关系良好,平均回收率为99.5%,RSD为0.80%(n=6)。结论:该方法简便、准确、可靠,可用于三草安神胶囊的质量控制。

Objective： To establish the quality standard for Sancao Anshen capsules. Methods： Valerian, Spica Prunellae, Radix Scutellariae and Rhizoma Coptidis were indentified by TLC. The content of rosmarinic acid was determined by HPLC. The column was Hypersil ODS2 C18 with mobile phase of acetonitrile-0.1% trifluoroacetic acid （30： 70, V/V） at a flow rate of 1.0 ml·min^-1, the column temperature was 25℃ ,the detection wavelength was 330 nm, and the sample size was 20 μl. Results： The characteristic spots could be detected by TLC with good reproducibility. The linear range of rosmarinic acid was 0. 105-2. 104 μg·ml^-1 （r =0.999 3）. The average recovery was 99.5% and the RSD was 0.80% （ n=6）. Conclusion： The developed method is simple and accurate, and suitable for the quality control of Saneao Ansben capsules.