一测多评法同时测定瓜蒌皮注射液中6种有效成分含量

Determination of Six Active Ingredients in Gualoupi Injection by Quantitative Analysis of Multi-components by Single Marker

目的:建立一测多评法(QAMS)测定瓜蒌皮注射液中6种有效成分含量。方法:采用HPLC法,色谱柱为Waters Sunfire ODS C_(18)柱(250 mm×4. 6mm,5μm),流动相为甲醇(A)-0. 2%冰乙酸水溶液(B)梯度洗脱,流速为1. 0 ml·min^(-1),检测波长为254 nm,柱温为30℃,进样量为20μl。以3,29-二苯甲酰基栝楼仁三醇为参照物,应用QAMS测定3,29-二苯甲酰基栝楼仁二醇、香草酸、腺苷、槲皮苷、木犀草苷相对较正因子并计算含量,同时与外标法测定结果进行比校。结果:3,29-二苯甲酰基栝楼仁二醇、香草酸、腺苷、槲皮苷、木犀草苷5种有效成分一测多评法计算值与外标法测定值差异无统计学意义(P>0. 05)。结论:一测多评法可用于瓜蒌皮注射液6种有效成分的含量测定,且结果准确、方法简单、有效。

Objective： To develop a method of quantitative analysis of multi-components by single marker（ QAMS） for six active ingredients in Gualoupi injection. Methods： An HPLC method was used with a Waters Sunfire ODS C18 column（ 250 mm × 4. 6 mm,2. 5 μm）,the mobile phase was methanol（ A）-0. 2% glacial acetic acid solution（ B） with gradient elution,the flow rate was 1. 0 ml·min^-1,the detection wavelength was 254 nm,the column temperature was 30℃ and the injection volume was 20 μl. Using 3,29-dibenzoyl rarounitriol as a reference,the relative correction factors among karounidiol,vanillic acid,adenosine,quercitrin and cynaroside were detected by QAMS and their contents were calculated,and the results were compared with those of the external standard method. Results： The differences were not statistically significant between the calculated values of karounidiol,vanillic acid,adenosine,quercitrin and cynaroside and those measured by the external standard method（ P〉 0. 05）. Conclusion： QAMS can be used for the determination of 6 effective components in Gualoupi injection,and the result is accurate,simple and effective.