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目的:建立高效液相色谱-质谱法同时测定中药复方制剂红竹海狗丸中人参皂苷Rg1、淫羊藿苷、补骨脂素和异补骨脂素的含量。方法:固定相为Agilent Tc-C18(4.6 mm×250 mm,5μm),流动相为0.1%醋酸和乙腈,梯度洗脱,流速为1.0 mL.min-1;ESI+,选择性监测(SIM)质荷比(m/z)为209,321,677,823的离子对,内标为劳拉西泮。结果:人参皂苷Rg1、淫羊藿苷、补骨脂素和异补骨脂素分别在2.02～12.12,2.0～12.0,0.53～1.86,0.4～1.4μg.mL-1浓度范围内线性关系良好。红竹海狗丸每丸分别含人参皂苷Rg1(232.6±0.64)μg、淫羊藿苷(669.0±14.51)μg、补骨脂素(564±34.71)μg和异补骨脂素(428±20.17)μg。结论:所建立的方法方便、快捷、稳定,可同时测定红竹海狗丸多种成分含量。结果准确可靠,可用于红竹海狗丸的制剂质量控制,为其人体药动学研究提供依据。
Objective: To establish a HPLC-MS method for the simultaneous determination of ginsenoside Rg1, icariin, psoralen and isopsoralen in Hongzhu Haigou Pills. Methods: The stationary phase was Agilent Tc-C18 (4.6 mm×250 mm, 5 μm), the mobile phase was 0.1% acetic acid and acetonitrile, gradient elution, flow rate was 1.0 mL.min-1; ESI+, selective monitoring (SIM) quality The charge ratio (m/z) is 209,321,677,823 ion pairs and the internal standard is lorazepam. Results: The ginsenoside Rg1, icariin, psoralen and isopsoralen had good linearity in the concentration range of 2.02-12.12, 2.0-12.0, 0.53-1.86, 0.4-1.4 μg.mL-1, respectively. Each pill of Hongzhu Haima Pill contained ginsenoside Rg1 (232.6±0.64) μg, icariin (669.0±14.51) μg, psoralen (564±34.71) μg, and isopsoralen (428±20.17). )μg. Conclusion: The established method is convenient, rapid and stable. It can simultaneously determine the contents of various components of Hongzhu Haima Pill. The results are accurate and reliable, and can be used to control the quality of preparations of Hongzhu Haigou Pills, and provide basis for the study of pharmacokinetics of the human body.