护肝宁制剂HPLC指纹图谱及化学模式识别研究  

Studies on the HPLC Fingerprint and Chemical Pattern Recognition of Huganning Preparation

作　　者：吴琦 王秋实 陈乃江 Wu Qi;Wang Qiushi;Chen Naijiang(Lianyungang Food and Drug Inspection Center,Jiangsu Lianyungang 222006,China)

机构地区：[1]连云港市食品药品检验检测中心,江苏连云港222006

出　　处：《中国药师》2020年第2期273-276,共4页China Pharmacist

摘　　要：目的:采用HPLC法建立护肝宁的指纹图谱,并结合化学模式识别对其质量进行分析评价。方法:采用CAPCELL PAK C18MGⅡ(200 mm×4.6 mm,5μm)色谱柱,以乙腈-0.1%磷酸溶液为流动相进行梯度洗脱,流速为1.0 ml·min^-1,检测波长为280nm,柱温为30℃,建立11批护肝宁制剂的指纹图谱,通过相似度分析并结合聚类分析(CA)、主成分分析(PCA)及正交偏最小二乘法判别分析(OPLS-DA)等模式识别技术对护肝宁制剂的质量进行分析评价。结果:建立的指纹图谱共标定27个共有峰,通过对照品保留时间和紫外吸收光谱确定5个共有峰,11批护肝宁样品指纹图谱的相似度均大于0.86,表明该药物总体质量较为稳定,但通过CA及PCA均发现不同厂家不同批次药物之间仍存在差异,通过OPLS-DA筛选出对药物质量差异影响最大的4个共有峰。结论:建立的分析方法简便、准确、可靠,指纹图谱结合化学模式识别分析可更好地评价护肝宁制剂的质量,为该制剂的质量控制提供科学依据。Objective:To establish an HPLC fingerprint of Huganning and to assess the quality by chemical pattern recognition.Methods:A CAPCELL PAK C18 MGⅡ(200 mm×4.6 mm,5μm)chromatographic column was employed,the separation was performed with the mobile phase consisting of acetonitrile and 0.1%phosphoric acid aqueous solution at a flow rate of 1.0 ml·min^-1,the detection wavelength was 280 nm and the column temperature was 25℃to establish the HPLC fingerprint of Huganning.And then,the further drug quality assessment was carried out by similarity evaluation,cluster analysis(CA),principal component analysis(PCA)and orthogonal partial least squares discriminant analysis(OPLS-DA).Results:Totally 27 peaks were recognized as the common peaks in the fingerprint,and among them,5 peaks were identified using the standard references.The similarity value was all above0.86,indicating relatively stable quality of the drug.Difference was discovered between the batches from different manufacturers by CA and PCA.Finally,4 peaks were recognized as the quality markers by OPLS-DA.Conclusion:The analysis method established in this study is simple,accurate and reliable.The combination of fingerprint with chemical pattern recognition can evaluate the quality of Huganning well and provide scientific basis for the quality control of the preparation.

关 键 词：护肝宁制剂 高效液相色谱法 指纹图谱 化学模式识别 

分 类 号：TQ460.72[医药卫生—药物分析学]