[关键词]
[摘要]
目的 建立15批经典名方养胃汤基准样品UPLC指纹图谱及其7种成分的定量分析方法,为养胃汤质量控制提供科学依据。方法 采用UPLC法,建立15批养胃汤基准样品UPLC指纹图谱。采用“中药色谱指纹图谱相似度评价系统”对15批养胃汤基准样品指纹图谱进行相似度评价。采用超高效液相联合二极管阵列检测器及蒸发光散射检测器,建立人参皂苷Rg1、Re、Rb1和橙皮苷、和厚朴酚、厚朴酚及甘草酸7个成分的含量测定方法。结果 15批养胃汤基准样品UPLC指纹图谱相似度均大于0.9。经与对照品比对指认出奎宁酸、腺苷、鸟苷、新绿原酸、苍术苷A、绿原酸、隐绿原酸、儿茶素、甘草苷、芹糖甘草苷、柚皮苷、橙皮苷、毛蕊花糖苷、甘草酸、6-姜辣素、川陈皮素、橘皮素、和厚朴酚、广藿香酮、厚朴酚20个色谱峰。15批养胃汤基准样品人参皂苷Rg1、Re、Rb1和橙皮苷、和厚朴酚+厚朴酚、甘草酸的质量分数均值的±30%范围分别为0.084~0.155、0.065~0.120、0.246~0.457、4.911~9.120、0.971~1.804、0.990~1.838 mg/g。结论 建立的养胃汤基准样品UPLC指纹图谱和7种指标性成分的含量测定方法专属性强、灵敏度高、重复性好,可用于养胃汤基准样品的质量评价,为其后续制剂开发和质量控制研究提供参考。
[Key word]
[Abstract]
Objective To establish UPLC fingerprint of 15 batches classic prescription Yangwei Decoction benchmark samples and quantitative analysis method of seven components to provide scientific basis for quality control of Yangwei Decoction. Methods UPLC fingerprint of 15 batches of benchmark samples was obtained by UPLC. The fingerprint similarity of 15 batches of benchmark samples was evaluated by the method of traditional Chinese medicine chromatographic fingerprint similarity evaluation system. The content determination method of ginsenoside Rg1, Re, Rb1, and hesperidin, honokiol, magnolol and glycyrrhizic acid was established by means of ultra-high performance liquid phase combined diode array detector and evaporative light scattering detector. Results The similarity of UPLC fingerprint of 15 batches of benchmark samples was greater than 0.9. After comparison with the reference, a total of 20 chromatographic peaks of quinic acid; adenosine, guanosine, neochlorogenic acid, atractyloside A, chlorogenic acid, cryptochlorogenic acid, catechin, liquiritin, liquiritin apioside, naringin, hesperidin, verbascoside, glycyrrhizinic acid, 6-gingerol, nobiletin, tangeritin, honokiol, pogostone, magnolol were identified. The mean content of ginsenoside Rg1, Re, Rb1, and hesperidin, honokiol and magnolol and glycyrrhizic acid ± 30% was 0.084 − 0.155, 0.065 − 0.120, 0.246 − 0.457, 4.911 − 9.120, 0.971 − 1.804, 0.990 − 1.838 mg/g, respectively. Conclusion The established UPLC fingerprint of Yangwei Decoction benchmark sample and the content determination method of seven index components have high specificity, high sensitivity and good repeatability, which can be used for the quality evaluation of Yangwei Decoction and provide reference for its subsequent preparation development and quality control research.
[中图分类号]
[基金项目]
2019年广东省佛山市核心技术攻关项目(1920001000378);2022年广东省联合培养研究生示范基地项目“国药集团广东环球制药有限公司”;2023年佛山基地联合培养扶持项目“经典名方复方制剂基准样品质量控制方法研究”