雷公藤制剂UPLC指纹图谱研究及4种效应成分的含量测定

Fingerprints and Content Determinations of Four Active Components of Tripterygium Preparations by UPLC

为建立不同厂家雷公藤制剂的UPLC指纹图谱,并同时测定制剂中4种效应成分的含量,为雷公藤制剂的质量控制提供参考和快速的检测方法。采用超高效液相色谱(UPLC)法进行分析,色谱柱:BEH Shield RP18(2.1 mm×100 mm,1.7μm),乙腈-水为流动相梯度洗脱,流速:0.25 m L/min,柱温35℃,在220 nm波长下进行测定;分别从定性和定量2个方面对不同厂家雷公藤制剂的UPLC指纹图谱进行相似性评价。结果显示不同厂家雷公藤制剂的指纹图谱明显不同,4种效应成分的含量差异显著。表明采用UPLC法测定雷公藤制剂指纹图谱专属性强,检测速度快,分离度好,可结合4种效应成分的含量测定全面控制雷公藤制剂的质量,确保临床用药安全与有效。

To establish fingerprints of Tripterygium preparations from different manufacturers, and to simultaneously determine the contents of four active components by ultra performance liquid chromatogra-phy （UPLC）,providing a rapid detection method for quality control of Tripterygium preparations.UPLC separation was performed on a BEH Shield RP 18 column （2.1 mm ×100 mm,1.7 μm）with a mobile phase of acetonitrile-water under gradient elution,the flow rate was 0.25 mL/min and the column tem-perature was 35 ℃,the detection wavelength was set at 220 nm.The similarity of UPLC fingerprints was evaluated by qualitative and quantitative analysis,respectively.The results showed that the fingerprints of Tripterygium preparations from different manufacturers were found to be in great diverse,while the contents of four active components were significantly different.So,this method is specific,fast,and with good resolution for the determination of UPLC fingerprint of Tripterygium preparations.The simulta-neous determination of contents of four active components can be used for the quality control of Tripterygi-um preparations to ensure the safety and utility in clinical medication.