双黄连粉针剂超声雾化前后3种成分的质量分析

Quality Analysis of Three Components in Shuanghuanglian Powder for Injection Before and After Ultrasonic Atomization

目的建立双黄连粉针剂超声雾化液中绿原酸、连翘苷、黄芩苷反向-高效液相色谱（ RP-HPLC）同步测定的新方法。方法色谱柱 Hypersil ODS2 C18（250 mm±4.6 mm,5μm）,流动相为甲醇-0.2%磷酸水溶液（4060）,流速1.0 mL·min-1,进样量5μL,柱温30℃,检测波长0-10 min为324 nm,10-25 min为277 nm。结果绿原酸、连翘苷、黄芩苷分别在进样量范围内与峰面积线性关系良好,r≥0.9997,精密度、重复性、稳定性均RSD〈2%,回收率98.50%-101.12%（n=6）。结论该方法快速、准确、重复性好、分离度高,可同时测定3种成分的含量。双黄连粉针剂超声雾化前后3种成分变化不大。

Objective To establish a new RP-HPLC method for simultaneous determination of chlorogenic acid,forsythin, and baicalin in shuanghuanglian powder for injection after ultrasonic atomization. Methods Hypersil ODS2 C18（250 mm±4. 6 mm,5 μm） was used as the chromatographic column. The mobile phase was methanol-0. 2% phosphate acid solution （4060）. Flow rate was 1. 0 mL·min-1 . Sample volume was 5μL. Column temperature was 30℃. Detection wavelength was 324 nm at 0-10 min and 277 nm at 10-25 min. Results Contents of chlorogenic acid,forsythin, and baicalin had good linear relationship with the respective peak area （r≥0. 999 7） within the scope of the sample volume. The RSD was〈2% for precision, reproducibility, and stability. Recovery rate was 98. 50%-101. 12% （n=6）. Conclusion The method is rapid, accurate and reproducible, with high resolution. It can determine the content of three kinds of components at the same time. The three components in shuanghuanglian powder for injection did not change significantly before and after ultrasonic atomization.