高效液相色谱法测定消银胶囊中苦参碱和牛蒡苷的含量

摘要

目的:探讨高效液相色谱法测定消银胶囊中苦参碱和牛蒡苷的含量,阐释中药合理配伍的科学内涵.方法:精密量取10 μL的样品进样量或对照品溶液,采用250 mm×4.6 mm,5 μm的色谱柱,选择流动相的条件是在乙腈和0.1%磷酸(12:88)的中以1 mL/min的流速开展实验,柱温为30 ℃,检测波长为230 nm,根据高效液相色谱法(HPLC)指纹图谱的梯度洗脱程序进行试验,并在LCsolution色谱工作站上进行指纹图谱分析消银胶囊中苦参碱和牛蒡苷的含量.结果:通过HPLC指纹图谱分析,牛蒡苷和苦参碱对照品分别于供试品溶液的色谱峰保留时间一致,且阴性对照溶液未对其造成干扰影响.牛蒡苷此在0.14~3.5 μg范围内线性关系良好;苦参碱在0.1~2.0 μg范围内线性关系良好.牛蒡苷加样回收率试验结果中平均回收率为99.80%,RSD 为2.01%;苦参碱加样回收率试验结果中平均回收率为108.24%,RSD 为1.97%.不同批次消银胶囊中牛蒡苷和苦参碱的含量差异无统计学意义(P>0.05),平均每粒消银胶囊中牛蒡苷含量为0.817 mg,苦参碱为0.437 mg.结论:高效液相色谱法可用于消银胶囊中苦参碱和牛蒡苷含量测定,进而对该药物进行质量控制.%Objective:To establish a HPLC method for determination of the content of matrine and Arctium lappa in Xiaoyin cap-suler,and to explain the scientific connotation of the rational compatibility of Chinese medicine.Methods:The precise amount of 10 μL sample or standard solution was obtained,using 250 mm×4.6 mm,5 μm chromatographic column.Mobile phase condition was in acetonitrile and 0.1% phosphoric acid(12:88)in a 1 mL/min flow to carry out the experiment,and the column tempera-ture was 30 ℃.The detection wavelength was 230 nm, according to the high performance liquid phase(HPLC)test fingerprint gradient elution program,and the content of matrine and elimination of arctiin in Xiaoyin capsule fingerprint was analyzed in LCso -lution chromatography workstation.Results:1)By HPLC fingerprint analysis, the retention time of the chromatographic peaks in the sample solution was consistent,and the negative control solution did not interfere with it.2)It had good internal relations in the range of 0.14 ~3.5 g, and the internal relations of matrine were good in the range of 0.1-2 g.3)The average recovery was 99.80%,and RSD was 2.01% in arctiin sample recovery test.The average recovery was 108.24% and RSD was 1.97% in ma-trine sample recovery test.4)There was no significant difference between the content of arctiin and matrine in different batches of Xiaoyin capsule(P>0.05).The average content of arctiin in each capsule was 0.817 mg,and matrine was 0.437 mg.Conclu-sion:HPLC can be used to determine the content of matrine and arctiin in Xiaoyin capsule,and then to control the quality of the drug.