三波长HPLC指纹图谱和7组分测定评价银黄片质量

Quality Evaluation of Yinhuang Tablets via Digitized and Quantified Fingerprints by High Performance Liquid Chromatography and Seven Components Detection

目的建立银黄片三波长高效液相色谱(HPLC)指纹图谱和7组分测定评价方法,为全面评价不同厂家银黄片质量提供依据。方法采用反相高效液相色谱(RP-HPLC)法,Agilent Poroshell 120 SB C18色谱柱(4.6 mm×150 mm,2.7μm),0.2%磷酸溶液-甲醇为流动相,线性梯度洗脱,流速为0.5 m L·min-1,柱温(35.00±0.15)℃,紫外检测波长为214,278,326 nm,进样量5μL,并用中药色谱指纹图谱超信息特征数字化评价系统4.0版软件对13批银黄片进行质量等级评价。以绿原酸、咖啡酸、黄芩苷、汉黄芩苷、黄芩素、汉黄芩素和野黄芩苷的含量作为评价指标,比较5个不同厂家银黄片的质量差异。结果以黄芩苷为参照物峰,分别确定28(214 nm)、29(278 nm)和26(326 nm)个共有指纹峰,建立了银黄片高效液相色谱三波长指纹图谱。系统指纹定量法评价发现5个厂家的银黄片化学指纹含量差异较大。结论不同厂家生产的银黄片质量差异较大,有必要建立多波长和多指标定量控制方法。该法为银黄片质量控制提供了新参考。

Objective To establish the quality control of Yinhuang tablet （YHT） by using sever ingredients determina-tion and tri-wavelength fingerprint analysis technologies. Methods The chromatographic fingerprints were developed by using Agilent Poroshell 120 SB C18（4. 6 mm×150 mm, 2. 7 μm） as the separation column and 0. 2% H3 PO4-methanol as the mobile phase. The flow rate was 0. 5 mL·min^-1 , the UV absorbance was monitored at 214, 278 and 326 nm by injecting 5 μL of the sample solution and the column temperature was maintained at （35. 00±0. 15） ℃ . The chromatographic fingerprints were charac-teristically evaluated for quality ranking of 13 batches of YHT by the 4. 0 software of the digitized evaluation system of traditional chinese medicine fingerprint with the super information characteristics. Seven marker compounds including chlorogenic acid, caf-feic acid, baicalin, wogonoside, baicalein, wogonin and scutellarin were simultaneously determined to compare the variation a-mong five different manufacturers. Results The tri-wavelength fingerprint high performance liquid chromatography method was established. A total of 28（214 nm）,29（278 nm）and 26（326 nm）common peaks were identified at respective wavelengths, using baicalin （BCL） as the referential peak. The software was applied to evaluate the YHT-HPLC fingerprints and identify the quality of 13 batches of YHT by systematically quantified fingerprint method （SQFM）. The results showed that the content from the dif-ferent manufacturers varied greatly. Conclusion The quality of YHT varies between different makers, and is necessary to es-tablish the criterion for quality control. This method can provide a new reference for the quality control of YHT.