婴儿健脾散的高效液相色谱双波长指纹图谱研究

HPLC Dual-wavelength Chromatographic Fingerprint Analysis of Ying’er Jianpi Powder

目的 建立婴儿健脾散的高效液相色谱(HPLC)指纹图谱,为其质量控制提供依据。方法 采用HPLC法,色谱柱为Polypak C色谱柱(4.6 mm×250 mm,5μm);以0.1%甲酸溶液-乙腈为流动相,梯度洗脱;流速:1.0 mL·min;检测波长:245、285 nm;柱温:30℃;进样量:20μL。采用《中药色谱指纹图谱相似度评价系统(2004A版)》,结合聚类分析对13批不同企业的婴儿健脾散样品的指纹图谱进行评价。结果 13批婴儿健脾散HPLC双波长指纹图谱中有14个共有峰,并指认了木香烃内酯、去氢木香内酯、白术内酯Ⅰ3个成分;相似度评价结果显示,1批样品的相似度为0.578,4批样品的相似度在0.847~0.894之间,其余8批样品的相似度均在0.92以上。聚类分析可将13批样品聚为三大类。结论 建立的双波长指纹图谱方法简便可靠,可为婴儿健脾散的整体质量评价提供基础数据。

Objective To establish an HPLC fingerprint for Ying’er Jianpi Powder,and provide reference for its quality control. Methods The HPLC separation was performed on a Polypak Ccolumn(4.6 mm×250 mm,5 μm)by gradient elution of 0.1% formic acid-acetonitrile at a flow rate of 1.0 mL·min. The detection wavelength was245 nm and 285 nm. The column temperature was 30 ℃ and the injection volume was 20 μL. The similarity Evaluation System of Traditional Chinese Medicine Chromatographic Fingerprint(2004A edition) combined with cluster analysis was used to evaluate the HPLC chromatographic fingerprint of 13 batches of Ying’er Jianpi Powder from various manufacturers. Results There were 14 common peaks in the dual wavelength HPLC chromatographic fingerprints of 13 batches of Ying’er Jianpi Powder, and 3 components(costunolide, dehydrocostuslactone,atractylenolide Ⅰ)were identified. Similarity evaluation results showed that:the similarity of 1 batch of sample was0.578,4 batch of samples were between 0.847 and 0.896,and the others were above 0.92. The results of cluster analysis showed that 13 batches of samples could be grouped into three categories. Conclusion The established method of dual-wavelength chromatographic fingerprint is simple and reliable,and provides essential data for the overall quality evaluation of Ying’er Jianpi Powder.