穿心莲药材及其制剂中6个内酯类成分的含量分析

目的: 建立RP-HPLC法同时测定穿心莲药材及其制剂中6个主要内酯成分(穿心莲内酯、异穿心莲内酯、新穿心莲内酯、去氧穿心莲内酯、脱水穿心莲内酯和穿心莲宁)的含量。 方法: 采用Kromasil RP-C₁₈(4.6 mm×250 mm,5 μm)色谱柱,以乙腈-水为流动相,采用二元梯度洗脱,流速1.0 mL·min^-1,检测波长226 nm,柱温25 ℃。 结果: 穿心莲内酯、异穿心莲内酯、新穿心莲内酯、去氧穿心莲内酯、脱水穿心莲内酯和穿心莲宁的线性范围分别为0.17~6.72 μg(r=0.9970),0.04~1.67 μg(r=0.9967),0.11~4.32 μg(r=0.9964),0.11~4.32 μg(r=0.9969),0.19~7.60 μg(r=0.9965),0.03~1.24 μg(r=0.9972);穿心莲药材平均加样回收率(n=6)分别为100.5%(RSD=2.3%),100.7%(RSD=2.9%),99.3%(RSD=2.1%),100.8%(RSD=3.0%),100.9%(RSD=3.0%),101.3%(RSD=2.7%)。 结论: 所建立的含量测定方法简便可行,重复性良好,可用于穿心莲药材及含穿心莲制剂的质量监控,也为提高穿心莲的质量标准和指导工艺改进提供新的试验依据。

Objective: To develop an RP-HPLC method for determination of andrographolide,homodroandrographolide,neoandrographolide,deoxyandrographolide,dehydroandrographolide,ninandrographolide in materials and related patent medicines of Andrographis paniculata. Methods: The samples were separated on a Kromasil RP-C₁₈(4.6 mm×250 mm,5 μm) column with the gradient elution of acetonitrile-water at a flow rate of 1.0 mL·min^-1.The wavelength was set at 226 nm and the column temperature was 25 ℃.In gradient elution program the volume fraction of acetonitrile in mobile phase was as follows:0-10 min,30%;10-20 min,30%→40%;20-25 min,40%;25-40 min,40%→50%;40-70 min,50%→65%. Results: The standard calibration curves of andrographolide,homodroandrographolide,neoandrographolide,deoxyandrographolide,dehydroandrographolide and ninandrographolide were linear in the ranges of 0.17-6.72 μg(r=0.9970),0.04-1.67 μg(r=0.9967),0.11-4.32 μg(r=0.9964),0.11-4.32 μg(r=0.9969),0.19-7.60 μg(r=0.9965),0.03-1.24 μg(r=0.9972),respectively;The average recoveries of the method of Andrographis paniculata materials were 100.5%(RSD=2.3%),100.7%(RSD=2.9%),99.3%(RSD=2.1%),100.8%(RSD=3.0%),100.9%(RSD=3.0%),101.3%(RSD=2.7%),respectively. Conclusion: The method established was successfully applied to quantify the six lactones in Andrographis paniculata collected in different places,which is helpful to control the quality and technonical improvement of Andrographis paniculata and its related products.