一测多评法同时测定金参化湿胶囊中5种活性成分含量OA
Simultaneous Determination of Five Active Components in Jinshen Huashi Capsules by QAMS
目的 建立同时测定金参化湿胶囊中升麻素苷、芍药苷、5-O-甲基维斯阿米醇苷、木香烃内酯、去氢木香烃内酯的一测多评(QAMS)法.方法 色谱柱为依利特BDS HypersilTM C18 柱(250 mm×4.6 mm,5 μm),流动相为乙腈-0.05%磷酸水溶液(梯度洗脱),流速为 1.0 mL/min,检测波长为 225 nm,柱温为 30℃,进样量为 10 μL.以芍药苷为内标物,计算其他 4 种成分的相对校正因子(RCF),分别以QAMS法测定含量,通过QAMS法和外标法的Pearson系数(r)验证结果的可靠性.结果 上述 5 种成分质量浓度分别在 5.58～55.81 μg/mL、18.78～187.83 μg/mL、7.39～73.91 μg/mL、4.78～47.81 μg/mL、4.99～49.98 μg/mL范围内与峰面积线性关系良好(r≥0.9997,n=6);检测限为 0.15～0.63 μg/mL;精密度、稳定性、重复性试验结果的RSD均小于 4.0%;平均加样回收率为 97.52%～99.22%,RSD为 0.72%～2.14%(n=6).升麻素苷、5-O-甲基维斯阿米醇苷、木香烃内酯、去氢木香烃内酯相对于芍药苷的RCF分别为 0.491,0.491,0.796,0.946,两种方法上述 4 种成分的r均≥0.997.结论 建立的QAMS法可为金参化湿胶囊的质量控制提供参考.
Objective To establish a quantitative analysis of multi-components by single-marker(QAMS)method for simultaneous determination of prim-O-glucosylcimifugin,paeoniflorin,5-O-methylvisammioside,costunolide and dehydrocostus lactone in Jinshen Huashi Capsules.Methods The chromatographic column was BDS HypersilTM C18 column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.05%phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 225 nm,the column temperature was 30 ℃,and the injection volume was 10 μL.Paeoniflorin was used as the internal standard to calculate the relative correction factor(RCF)of the other four components,and the content was determined by QAMS method.The reliability of the results was verified by the pearson correlation cofficient(r)between QAMS method and the external standard method.Results The linear range of the above five components were 5.58-55.81 μg/mL,18.78-187.83 μg/mL,7.39-73.91 μg/mL,4.78-47.81 μg/mL,4.99-49.98 μg/mL,respectively(r≥0.999 7,n=6),and the limit of detection was 0.15-0.63 μg/mL;the RSDs of precision,stability,and repeatability test results were all lower than 4.0%;the average recovery rate was 97.52%-99.22%,with RSDs of 0.72%-2.14%(n=6).The RCFs of prim-O-glucosylcimifugin,5-O-methylvisammioside,costunolide and dehydrocostus lactone relative to paeoniflorin were 0.491,0.491,0.796 and 0.946,respectively.The r of the above four components by the two methods were all≥0.997.Conclusion The established QAMS method can provide reference for the quality control of Jinshen Huashi Capsules.
许庆;朱正华;荀秀彪;肖植国;李涛会
云南省曲靖市检验检测认证院,云南 曲靖 655000云南省曲靖市检验检测认证院,云南 曲靖 655000云南省曲靖市检验检测认证院,云南 曲靖 655000云南省曲靖市检验检测认证院,云南 曲靖 655000云南省曲靖市妇幼保健院,云南 曲靖 655000
医药卫生
金参化湿胶囊一测多评法相对校正因子多组分定量测定
Jinshen Huashi Capsulequantitative analysis multi-components by single-markerrelative correction factormulti-componentquantitative determination
《中国药业》 2026 (4)
109-113,5
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