柴胡注射液有效成分的含量测定及指纹图谱模式识别的研究

Determination of active components and the pattern recognition of the fingerprint of Bupleuri Radix injection

目的 采用HPLC法测定柴胡注射液中柴胡皂苷A的含量,建立柴胡注射液的指纹图谱识别模式。方法 采用Swell Chromplus C18色谱柱（250 mm×4.6 mm,5μm）,流动相为乙腈-水,梯度洗脱,流速1.0 m L·min^（-1）,进样量25μL,检测波长204 nm,柱温35℃;采用相似度评价软件来评价相似度,运用主成分分析和聚类分析对指纹图谱进行模式识别研究。结果10批样品中柴胡皂苷A的含量为7.198~7.406μg·m L^（-1）;通过测定27批样品的指纹图谱,确定了15个共有峰（相似度均大于0.8）,主成分分析法提取出4个主成分,占总变异的85%以上,由聚类分析得出S20~27这8个样品在三维图中的分布相对集中。结论 所用方法简便、准确、重复性好,可为柴胡注射液的质量控制提供依据。

OBJECTIVE To determine the active compound of Bupleuri Radix injection（BILl） and its fingerprint pattern recognition by RP - HPLC method. METHODS The HPLC method was carried out on Swell chromplusTM - Ci8 （ 250 mm× 4.6 mm, 5 μm） using water（A） - acetonitrile （ B ） as the mobile phase. Flow rate was 1.0 mL min -1, sampling volume was 25 μL, column temperature was 35 ℃, and detection wavelength was 204 nm. The fingerprint recognition pattern was established by using principle component analysis and clustering analysis based on the results from 27 batches of BILl. And the similarity evaluation software was used to evaluate the similarity. RESULTS The content of saikosaponin A was 7. 198 - 7. 406 μg mL-1 for 10 batches of BRJ. And there were 15 common peaks in the fingerprint of 27 batches of BRJ （ similarity 〉 0. 8 ）. Four principle components were extracted by principle component analysis（ 85% of total variant）. Clustering analysis of S20 -27 suggested that the distribution of the samples in the three - dimensional map were relatively centered. CONCLUSON The method is simple, accurate and reproducible, and it can be used in quality control of BRJ.