基于HPLC-UV特征图谱与主成分分析的蔓荆子配方颗粒的质量控制研究

Quality evaluation of Viticis Fructus formula granules based on HPLC-UV characteristic spectrum and principal component analysis

[目的]通过对蔓荆子配方颗粒中原儿茶酸、对羟基苯甲酸和蔓荆子黄素的含量测定与指纹图谱的研究,结合主成分分析研究不同产地蔓荆子的配方颗粒的质量。[方法]采用高效液相色谱-紫外检测器(HPLC-UV)对蔓荆子配方颗粒中原儿茶酸、对羟基苯甲酸和蔓荆子黄素进行含量测定,及其指纹图谱的绘制。色谱柱为Agilent ZOBRAX Plus C18(4.6 mm×250 mm,5μm),以0.1%磷酸水(A)-乙腈(B)为流动相进行梯度洗脱,流速1.0 m L/min,检测波长为程序波长,柱温35℃。采用SIMCA 14.1软件对指纹图谱特征峰进行主成分分析。[结果] 10批蔓荆子配方颗粒中的原儿茶酸、对羟基苯甲酸、蔓荆子黄素的含量最大相差分别为2.0倍、2.8倍、8.6倍,其中江西产地蔓荆子的配方颗粒3种活性成分含量均较高。不同产地蔓荆子的配方颗粒相似度在0.914~0.993之间,表明颗粒剂中的化学成分总体稳定。综合含量测定、指纹图谱与主成分分析的结果,可区分出江西产地蔓荆子的配方颗粒质量最佳,均一性良好。[结论]基于HPLC-UV法的含量测定结合指纹图谱分析与主成分分析的评价方法,在一定程度上可表征蔓荆子配方颗粒在化学成分方面的共性与差异,可以为蔓荆子配方颗粒甄选原药材、质量控制和评价提供相应的依据。

[Objective] Through the determination of protocatechuic acid,p-hydroxybenzoic acid and viticin content in Viticis Fructus formula granules and the study of fingerprint,and principal component analysis was used to evaluate the quality of Viticis Fructus formula granules from different origins.[Methods] High performance liquid chromatography-ultraviolet detector(HPLC-UV) and Agilent ZOBRAX Plus C18 chromatographyic column(4.6 mm ×250 mm,5 μm) was employed,the separation was performed with the mobile phase consisting of 0.1% phosphoric acid(A) and acetonitrile(B) solution,the flow rate was 1.0 m L/min,and the detection wavelength was set the programmed wavelength with 35 ℃ of column temperature to establish the HPLC content determination and fingerprint. The software of SIMCA 14.1 was for principal component analysis.[Results] The maximume content difference of protocatechuic acid,parahydroxybenzoic acid and viticin was 2.0 times,2.8 times and 8.6 times in the 10 batches of Viticis Fructus formula granules,respectively. The content of three active components in the formula granules prepared by Viticis Fructus of Jiangxi province was higher.The fingerprint similarity of formula granules from different origins is between 0.914 and 0.993,the chemical composition of formula granules is generally stable. The comprehensive results of content determination,fingerprint and principal component analysis showed that the formula granules prepared by Viticis Fructus of Jiangxi province have good quality and uniformity.[Conclusion] The content combined with fingerprint analysis and principal component analysis based on HPLC-UV method can characterize the commonalities and differences in the chemical composition of Viticis Fructus formula granules. It can provide some basis for selecting the original medicinal materials,quality control and evaluation for the Viticis Fructus formula granules.