活血止痛胶囊的高效液相指纹图谱建立、化学模式识别分析及3种成分的含量测定

目的:建立活血止痛胶囊的高效液相色谱(HPLC)指纹图谱及含量测定的方法,结合化学模式识别分析,为其质量评价提供依据.方法:采用Kromasil 100-5-C18(4.6mm×250 mm,5μm)色谱柱,乙腈-水为流动相,梯度洗脱,流速为1mL·min-1,柱温35℃,检测波长203 nm,测定其3种成分含量并建立...

Establishment of HPLC fingerprint,chemical pattern recognition analysis and content determination of three components in Huoxue Zhitong Capsules

OBJECTIVE To establish a method for the HPLC fingerprint and content determination of Huoxue Zhitong Capsules, and combine with chemical pattern recognition analysis to provide basis for its quality evaluation.METHODS The contents of three components were determined and HPLC fingerprint was established on a Kromasil 100-5-C₁₈(4.6 mm×250 mm, 5 μm) chromatographic column with acetonitrile-water as the mobile phase in a gradient elution manner. The flow rate was 1 mL·min^-1; the column temperature was 35 ℃; the detection wavelength was 203 nm. The similarity evaluation was carried out by using the Similarity Evaluation System of Chinese Medicine Chromatographic Fingerprint, and the common peaks were determined. SIMCA14.1 statistical software was used for chemical pattern recognition analysis, and the overall quality of Huoxue Zhitong Capsules was analyzed and evaluated.RESULTS The HPLC fingerprints of 21 batches of Huoxue Zhitong capsules were established, and 15 peaks were calibrated. The similarity between the fingerprint of each batch and the control spectrum was between 0.921 and 0.987. The results of cluster analysis and principal component analysis showed that the three different manufacturers were grouped into one category, and the orthogonal partial least square method was used to screen out 7 chromatographic peaks that caused the differences among the manufacturers. The linear ranges of notoginsenoside R₁, ginsenoside Rg₁ and ginsenoside Rb₁ in 21 batches of Huoxue Zhitong Capsules were 0.030 67-0.306 70 mg·mL^-1, 0.124 33-1.243 30 mg·mL^-1 and 0.132 33-1.323 30 mg·mL^-1, respectively.CONCLUSION The methods of HPLC content determination, fingerprint and chemical pattern recognition analysis established in this study are simple and feasible, and can be used for the quality control and evaluation of Huoxue Zhitong Capsules.