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[摘要]
目的 建立雷公藤多苷片的高效液相指纹图谱,考察不同生产厂家的雷公藤多苷片的一致性,为更好的完善该制剂的质量评价奠定基础。方法 采用高效液相色谱法,Agilent C18色谱柱(250 mm×4.6 mm,5 μm),流动相为乙腈-水,梯度洗脱(0~70 min,35∶65→100∶0);体积流量1.0 mL/min;柱温30℃;检测波长218 nm;进样量20 μL。结果 测定了7个厂家的指纹图谱,色谱图差距较大,提示不同厂家的雷公藤多苷片的化学成分不同或同成分但含量差别较大。确定了22个峰为雷公藤多苷片的共有峰,并利用主成分分析法(PCA)对指纹图谱进行处理,不同厂家的雷公藤多苷片可明显区分。结论 市售雷公藤多苷片的质量参差不齐,不同生产厂家雷公藤多苷片HPLC指纹图谱差异较大,该方法为更好地控制雷公藤多苷片的内在质量提供了有益的参考。
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[Abstract]
Objective To establish an HPLC fingerprint method of Tripterygium Glycosides Tablets (TGT), and to apply this method to determining the consistency of TGT fromdifferent manufacturers and supporting the foundation of quality control. Methods An HPLC analysis was performed on C18 column with water-acetonitrile gradient elution, flow-rate of 1.0 mL/min, column temperature of 30℃, detecting wavelength of 218 nm. Results HPLC fingerprints were obviously different among the seven manufacturers, which indicated that there were different chemical compositions or the same composition with different contents. Twenty-two common peaks were named as characteristic fingerprint peaks. Significant differences were observed among different manufacturers in the principal components analysis score plot. Conclusion Significant differences of quality in tripterygium glycosides tablets on the market are observed. The HPLC fingerprint of TGT is established which provides useful reference for quality control.
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