一测多评法同时测定损伤中期口服液中4个活性成分含量  

Simultaneous Content Determination of Four Active Constituents in Sunshang Zhongqi Oral Liquid by QAMS

作　　者：杨云芝 蒲立立 徐伟 何清华 赵薇 钟佰明 张明 雷果平 YANG Yunzhi;PU Lili;XU Wei;HE Qinghua;ZHAO Wei;ZHONG Baiming;ZHANG Ming;LEI Guoping(Traditional Chinese Medicine Preparation Center,Nanchong Hospital of Traditional Chinese Medicine,Nanchong 637000,China;Key Laboratory of Traditional Chinese Medicine for Prevention and Treatment of Skeletal Muscle Disease in Nanchong,Nanchong 637000,China;Nanchong Institute for Food and Drug Control,Nanchong 637000,China)

机构地区：[1]南充市中医医院,四川南充637000 [2]筋骨病中医药防治南充市重点实验室,四川南充637000 [3]南充市食品药品检验所,四川南充637000

出　　处：《中国现代中药》2025年第2期336-343,共8页Modern Chinese Medicine

基　　金：南充市科技计划项目(22ZXKTYJ0012,22YYJCYJ0062,23YYJCYJ0132);四川省科技计划项目(2021YFS0270)。

摘　　要：目的:建立一测多评法同时测定损伤中期口服液中4个活性成分的含量。方法:采用高效液相色谱法,Agilengt Zorbax SB-C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈(A)-0.2%磷酸水溶液(B),18%A等度洗脱,柱温为25℃,流速为1.0 m L·min^(–1),检测波长为284 nm,进样量为5μL。以柚皮苷为内标物,计算各成分的相对校正因子,并测定其含量,运用外标法(ESM)进行验证。结果:毛蕊异黄酮葡萄糖苷、柚皮苷、橙皮苷、新橙皮苷质量浓度分别为0.68~21.70、8.60~275.11、2.39~76.59、6.29~201.34μg·m L^(–1)时线性关系良好(r>0.999 5),平均加样回收率为96.5%~99.0%,精密度、稳定性、重复性的RSD均小于2.00%。以柚皮苷为内标物,毛蕊异黄酮葡萄糖苷、橙皮苷、新橙皮苷相对校正因子分别为0.984 8、1.074 0、0.969 2,且在不同条件下重复性良好,3个成分相对校正因子的RSD均小于4.00%,经ESM验证所测结果相对误差在±0.1%范围内;指标成分转移率分别为80.55%、47.72%、40.06%、57.17%。结论:该方法快速便捷、稳定可靠,可用于损伤中期口服液的质量控制。Objective:This paper aims to establish a quantitative analysis of multi-components by single-marker(QAMS)method for the simultaneous content determination of four active constituents in Sunshang Zhongqi Oral Liquid.Methods:The chromatographic column of Agilengt Zorbax SB-C_(18)(250 mm×4.6 mm,5μm)was used by high performance liquid chromatography(HPLC).The mobile phase was formed by acetonitrile(A)and 0.2%phosphoric acid solution(B),and 18%A isometric elution was performed.The column temperature was 25°C,and the flow rate was 1.0 mL·min–1.The detection wavelength was 284 nm,and the injection volume was 5μL.Naringin was used as an internal standard,and the relative correction factors of each constituent were calculated.The content was determined,and the external standard method was used for verification.Results:Galycosin 7-O-β-D-glucopyranoside,naringin,hesperidin,and neohesperidin had good linear relationships in the content range of 0.68-21.70,8.60-275.11,2.39-76.59,and 6.29-201.34μg·mL^(–1),respectively(r>0.9995).The average recoveries ranged from 96.5%to 99.0%,and the RSDs of precision,stability,and repeatability of the four constituents were all less than 2.00%.Naringin was used as the internal standard in the QAMS method,and the relative correction factors of galycosin 7-O-β-D-glucopyranoside,hesperidin,and neohesperidin were 0.9848,1.0740,and 0.9692 respectively.Moreover,the repeatability was good under different conditions,with RSDs of the three constituents less than 4.00%.The measured results were verified by the external standard method,with a relative error within±0.1%.The transfer rates of index components were 80.55%,47.72%,40.06%,and 57.17%,respectively.Conclusion:The method is rapid,convenient,stable,and reliable,and it can be used for the quality control of Sunshang Zhongqi Oral Liquid.

关 键 词：损伤中期口服液 一测多评法 相对校正因子 质量控制 

分 类 号：R286[医药卫生—中药学]