目的 建立同时测定防风通圣丸中7种有效成分含量的HPLC, 研究不同厂家生产的防风通圣丸的质量。方法 采用Kromasil C₁₈(4.6 mm×250 mm, 5 μm );流动相:甲醇(A)-0.5%醋酸溶液(B) 梯度洗脱:0~10 min(15%A), 10~15 min(15%~30%A), 15~40 min(30%~40%A), 40~80 min(40%~70%A), 80~120 min(70%~90%A);柱温:25 ℃;流速:1.0 mL·min^-1;检测波长:280 nm。结果 测得黄芩苷、汉黄芩苷、黄芩素、汉黄芩素、白杨素、大黄素和大黄酚的回收率分别为101.3%, 98.6%, 99.7%, 96.4%, 102.7%, 100.2%和98.4%, 且在2.33~300.0, 0.407~120.0, 1.563~50.0, 0.625~40.0, 0.625~77.8, 1.563~100和1.625~120 μg·mL^-1内, 线性关系良好(r≥0.999 2)。结论 采用反相高效液相色谱法的梯度洗脱模式能有效分析防风通圣丸中的7种有效成分, 方法准确可靠, 重复性好, 结果稳定, 可作为该产品质量控制的方法。

OBJECTIVE To develop an HPLC method for simultaneous determination of seven components in traditional Chinese medicines Fangfengtongsheng pills from different factories. METHODS The chromatographic analyses were carried out on a kromasil C₁₈ column(4.6 mm×250 mm, 5 μm); and the mobile phase was methanol(A)-0.5 acetic acid at 1.0 mL·min^-1 in gradient elution mode which was 15% A from 0 to 10 min, 15%-30% A from 10 to 15 min, 30%-40% A from 15 to 40 min, 40%-70% A from 40 to 80 min, and 70%-90% A from 80-120 min; the column temperature and detection wavelength were set at 25 ℃ and 280 nm, respectively. RESULTS Seven components were determined by HPLC, including baicalin, wogonoside, baicalein, wogonin, chrysin, emodin, and chrysophanol. The recoveries were 101.3%, 98.6%, 99.7%, 96.4%, 102.7%, 100.2% and 98.4%, respectively, and the linearity were good(r≥0.999 2) in the concentration ranges of 2.33-300.0, 0.407-120.0, 1.563-50.0, 0.625-40.0, 0.625-77.8, 1.563-100, and 1.625-120 μg·mL^-1. CONCLUSION Seven components are analyzed in Fangfengtongsheng pills by RP-HPLC with gradient elution, and the method has good specificity, reproducibility and high sensitivity, which can be applied to control the quality of Fangfengtongsheng pills.