乐儿康糖浆的质量控制

Quality Control of Le'erkang Syrup

目的建立高效液相色谱(HPLC)多指标成分定量测定与化学计量学相结合的乐儿康糖浆质量评价方法。方法采用Agilent TC-C_(18)色谱柱(250 mm×4.6 mm,5μm),柱温25℃;流动相乙腈-0.1%磷酸溶液,梯度洗脱,流速0.8 mL·min^(-1);检测波长203 nm(检测太子参环肽B)、305 nm(检测桑皮苷A、桑辛素M和二氢桑色素)和254 nm(检测毛蕊异黄酮葡萄糖苷、芒柄花苷、芒柄花素和桑辛素);基于多指标成分含量测定结果,采用聚类分析、主成分分析等化学计量学方法对不同企业生产的乐儿康糖浆进行质量评价。结果太子参环肽B、桑皮苷A、桑辛素M、二氢桑色素、毛蕊异黄酮葡萄糖苷、芒柄花苷、芒柄花素和桑辛素分别在0.86~17.20,2.19~43.80,1.87~37.40,0.76~15.20,2.64~52.80,1.71~34.20,4.97~99.40,1.18~23.60μg·mL^(-1)范围内线性关系良好(r≥0.9991);平均加样回收率分别为98.51%,99.38%,97.72%,96.96%,98.70%,97.91%,100.08%和99.03%,RSD分别为1.15%,0.92%,1.36%,1.25%,1.47%,1.12%,0.76%和0.83%;10批乐儿康糖浆供试品聚为2类,主成分分析结果表明主成分1—2是影响乐儿康糖浆质量评价的主要因子。结论该方法操作简便、重复性好,可用于乐儿康糖浆的质量控制。

Objective To establish a quality control method of Le'erkang syrup based on HPLC multi-index components and chemometrics analysis.Methods The analysis was performed on an Agilent TC-C_(18) column(250 mm×4.6 mm,5μm);and the column temperature was 25℃.The mobile phase was the acetonitrile-0.1%phosphoric acid aqueous solution at a flow rate of 0.8 mL·min^(-1) in a gradient elution manner.The detector wavelength was set at 203 nm for heterophyllin B,305 nm for mulberroside A,moracin M and dihydromorin,and 254 nm for calycosin 7-O-β-D-glucopyranoside,ononin,formononetin and morusin.The chemometrics methods such as cluster analysis and principal component analysis were used to evaluate the quality of Le'erkang syrup from different manufacturers based on the results of multi-index components content determination.Results Heterophyllin B,mulberroside A,moracin M,dihydromorin,calycosin 7-O-β-D-glucopyranoside,ononin,formononetin and morusin showed good linear relationships within the ranges of 0.86-17.20,2.19-43.80,1.87-37.40,0.76-15.20,2.64-52.80,1.71-34.20,4.97-99.40,1.18-23.60μg·mL^(-1)(r≥0.9991),whose average recoveries were 98.51%,99.38%,97.72%,96.96%,98.70%,97.91%,100.08%and 99.03%with the RSDs of 1.15%,0.92%,1.36%,1.25%,1.47%,1.12%,0.76%and 0.83%,respectively.The cluster analysis results showed that 10 batches of Le'erkang syrup were clustered into two groups,and the results of principal component analysis showed that the principal component 1-2 was the main factor affecting the quality evaluation of Le'erkang syrup.Conclusion The method is easy to operate and repeatable,which can be valued as a quality control method for Le'erkang syrup.