黄芪注射液中初生成分的鉴定及氨基酸类成分的含量测定

Identification of primary components and assay of amino acids in Astragalus injections

目的 鉴定黄芪注射液中的初生成分,并以氨基酸类成分含量为指标,评价不同来源黄芪注射液的质量差异。方法 采用液相二级质谱(LC-MS/MS)法,以0.1%甲酸乙腈-0.1%甲酸水为流动相,采用梯度洗脱检测黄芪注射液中初生成分。采用LC-MS/MS法,以10%甲醇水(含0.1%甲酸)和50%甲醇水(含0.1%甲酸)为流动相,采用梯度洗脱测定黄芪注射液中各氨基酸的含量,并采用主成分分析评价不同厂家黄芪注射液中氨基酸的含量差别。结果 不同厂家黄芪注射液中均检测到255个初生成分,主要为氨基酸类、有机酸类、糖类和含N类化合物。4个厂家黄芪注射液中氨基酸含量得分分别为-0.23,-1.77,-0.35,2.36。结论 不同厂家黄芪注射液中初生成分的种类一样,但含量不同;不同厂家黄芪注射液中氨基酸的含量差异较大。

Objective To identify the primary components in Astragalus injection and evaluate the quality differences of Astragalus injections from different manufacturers based on the contents of amino acids.Methods The primary components in Astragalus injection were detected by gradient elution using 0.1%acetonitrile formate and 0.1%formic acid water as mobile phase by LC-MS/MS method.With 10%methanol water(containing 0.1%formic acid)and 50%methanol water(containing 0.1%formic acid)as mobile phases,the content of each amino acid was determined after gradient elution,and the quality difference of amino acids in the primary components of Astragalus injections from different manufacturers was evaluated by principal component analysis.Results A total of 255 primary components were detected in all Astragalus injections from different manufacturers,including amino acids,organic acids,sugars and N-containing compounds.And the score of amino acid content in four manufacturers was-0.23,-1.77,-0.35,2.36,respectively.Conclusion The types of primary components in Astragalus injection from different manufacturers are the same,but the contents of primary components are different.The contents of amino acids in Astragalus injections from different manufacturers vary greatly.