超临界二氧化碳萃取联合色谱法测定益母草注射液中的总生物碱

目的构建超临界二氧化碳（CO2）苹取益母草注射液中总生物碱的方法，定量分析其盐酸水苏碱含量，为建立益母草注射液质量标准提供依据。方法应用超临界CO2萃取益母草注射液中总生物碱，以Spherisorb SCX色谱法定量测定益母草沌射液中盐酸水苏碱含量，色谱条件，Spherisorb SCX（250mm×4．6mm）色谱柱，以磷酸二氢钠溶液0．01mol／L（pH值为5．5）为流动相，柱温25℃，检测波长192mm，流速1．0ml／min，进样量为20μl。结果盐酸水苏碱进样量范围存0．6～5．0μg内，具有显著的线性关系，r=0．870，样品加样平均同收率为101．5％（n=8）。RDS=1．16％。结论超临界CO2萃取法简便稳定，结果可靠，可重复性强，是控制该制剂质量的优良方法。

Extraction of hydrochloric stachydrine in Leonurus heterophyllus injection by supercritical CO2 fluid extraction method and chromatography

Objective To establish a method to extract the total alkaloid in the Leonurus heterophyllus injection by supercritical CO2 fluid （SFE-CO2） extraction method and Spherisorb SCX and analyze quantitatively the hydrochloric stachydrine therein so as to provide a basis to establish the quality standard ofLeonurus heterophyllus injection. Methods Samples ofL. heterophyllus injection were studied on a Kromasil C18 column （5 μm, 250 mm×4.6 ram） using CH3CN-0.01 mol/L KDP （pH 5.5） as mobile phase under the flow-rate of 1.0 mL/min with the oven temperature of 25 ℃ and the detection wavelength of 192 nm. Results Hydrochloric stachydrine was well separated from other impurities. The method was validated for a linear range of 0.6 -5.0 μg for stachydrine （r=0.870）,the average recovery rate of hydrochloric stachydrine was 101.5% （n = 8） with a relative standard deviation of 1.16%. Conclusion Stable, simple, convenient, reliable, and sensitive, the supercritical CO2 fluid extraction method can be used for the quality control of L. heterophyllus injection.