山菊降压胶囊多指标成分含量测定及量值传递分析菊花成分变化  

Multi-component determination of Shanjujiangya capsules and analysis of compositional change in Chrysanthemi Flos by quantity transfer

作　　者：赵振霞 耿韫 雷蓉 尹璇 刘永利 ZHAO Zhen-xia;GENG Yun;LEI Rong;YIN-Xuan;LIU Yong-li(Hebei Institute for Drug and Medical Device Control,Hebei Key Laboratory of Traditional Chinese Medicine Quality Evaluation and Standard Research,Shijiazhuang 050227,China)

机构地区：[1]河北省药品医疗器械检验研究院河北省中药质量评价与标准研究重点实验室,石家庄050227

出　　处：《药物分析杂志》2024年第5期796-805,共10页Chinese Journal of Pharmaceutical Analysis

基　　金：河北省重点研发计划项目“中药质量特征标识新技术研究与应用”(21372502D)。

摘　　要：目的:建立高效液相色谱法同时测定山菊降压胶囊中新绿原酸、绿原酸、隐绿原酸、洋蓟素、木犀草苷、异绿原酸B、异绿原酸A、异绿原酸C 8个成分的含量,并结合量值传递规律对菊花化学成分的变化进行分析。方法:采用Waters Symmetry C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸为流动相,梯度洗脱,流速1.0 mL·min^(-1),柱温30℃,检测波长328 nm。以上述8个成分的转移率为主要评价指标,进行从饮片到提取液的量值传递分析。结果:8个成分新绿原酸、绿原酸、隐绿原酸、洋蓟素、木犀草苷、异绿原酸B、异绿原酸A、异绿原酸C分别在各自质量浓度范围内线性关系良好(r=0.9999),平均加样回收率为98.3%~101.9%,RSD为0.066%~0.64%。3批山菊降压胶囊样品中测得的上述8个成分的含量范围分别为0.257~0.279、0.629~0.650、0.402~0.476、0.454~0.539、1.118~1.278、0.653~0.740、0.659~0.706、1.138~1.167 mg·g^(-1)。结论:该研究所建立的含量测定方法简单可行,重复性、稳定性良好。量值传递分析更为含量方法的建立及限度的制定提供数据支持,本研究可为山菊降压胶囊质量控制方法研究提供依据。Objective:To establish a method for simultaneous determination of neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,cynarin,galuteolin,isochlorogenic acid B,isochlorogenic acid A,isochlorogenic acid C in Shanjujiangya capsules by HPLC and analyze compositional change of Chrysanthemi Flos combined with law of quantity transfer.Methods:The analysis was performed on Waters Symmetry C_(18)column(250 mm×4.6 mm,5μm),with mobile phase composed of acetonitrile-0.1%phosphoric acid solution at a flow rate of 1.0 mL·min^(-1)in gradient elution mode.The column temperature was 30℃and the detection wavelength was328 nm.The transfer rates of the above eight components were used as the indexes for quality evaluation to study the quantity value of transfer rule from the decoction piece to the extracting solution.Results:The results showed that the determination of eight components manifested a good linear relationship in the range of mass concentration(r>0.9999),the average recoveries of neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid,cynarin,galuteolin,isochlorogenic acid B,isochlorogenic acid A,isochlorogenic acid C were 98.3%-101.9%,with RSDs of 0.066%-0.64%.The contents of the above 8 components in 3 samples were 0.257-0.279 mg·g^(-1),0.629-0.650 mg·g^(-1),0.402-0.476 mg·g^(-1),0.454-0.539 mg·g^(-1),1.118-1.278 mg·g^(-1),0.653-0.740 mg·g^(-1),0.659-0.706,1.138-1.167 mg·g^(-1),respectively.Conclusion:The HPLC method established in this study is simple,repeatable and stable.The analysis of quantity transfer provides data support for the establishment of content methods and the formulation of limits.This study can provide basis for quality control method of Shanjujiangya capsules.

关 键 词：山菊降压胶囊 高效液相色谱法 含量测定 菊花 新绿原酸 绿原酸 隐绿原酸 洋蓟素 木犀草苷 异绿原酸 量值传递 转移率 

分 类 号：R917[医药卫生—药物分析学]