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作 者:贾银芝 吴琦 杜月莹 许柯 张水红 JIA Yin-zhi;WU Qi;DU Yue-ying;XU Ke;ZHANG Shui-hong(Lianyungang Laboratory of Jiangsu Institute for Food and Drug Control,Lianyungang Jiangsu 222006;Lianyungang Food and Drug Inspection Center,Lianyungang Jiangsu 222006)
机构地区:[1]江苏省食品药品监督检验研究院连云港检验室,江苏连云港222006 [2]连云港市食品药品检验检测中心,江苏连云港222006
出 处:《中南药学》2024年第11期3026-3030,共5页Central South Pharmacy
摘 要:目的建立抗菌消炎片(胶囊)的高效液相色谱(HPLC)指纹图谱。方法采用CAPCELL PAK C18色谱柱(4.6 mm×250 mm,5μm),以0.1%甲酸乙腈溶液-0.1%甲酸溶液为流动相进行梯度洗脱,流速为1.0 mL·min^(-1),柱温为30℃,进样量为10μL,DAD检测器采集波长为254 nm,CAD检测器雾化温度为50℃,建立抗菌消炎片(胶囊)的HPLC-DADCAD指纹图谱,并采用“中药色谱指纹图谱相似度评价系统”(2012版)计算11批样品的相似度。结果11批次抗菌消炎片(胶囊)的DAD(254 nm)指纹图谱与对照指纹图谱的相似度在0.900~0.992,CAD指纹图谱与对照指纹图谱的相似度在0.831~0.985,在DAD(254 nm)和CAD下分别标定了34个和21个共有峰,通过对照品比对法指认了其中12个共有峰,分别为绿原酸、芒果苷、木犀草苷、3,5-O-二咖啡酰奎宁酸、4,5-O-二咖啡酰奎宁酸、黄芩苷、槲皮素、黄芩素、大黄酸、汉黄芩素、大黄素和知母皂苷BⅡ。结论建立的HPLC-DAD-CAD指纹图谱分析方法为更加全面、快捷、准确地评价抗菌消炎片(胶囊)的质量提供了强有力的工具。Objective To establish the HPLC fingerprint of Kangjun Xiaoyan tablets(capsules).Methods HPLC fingerprints were established on CAPCELL PAK C18(4.6 mm×250 mm,5μm)chromatographic column with 0.1% formic acid acetonitrile solution-0.1% formic acid solution as the mobile phase in a gradient elution manner.The flow rate was 1.0 mL·min^(-1),the column temperature was 30℃,the injection volume was 10μL,the detection wavelength of DAD was 254 nm and the atomization temperature of CAD was 50℃.The HPLC-DAD-CAD fingerprints of the 11 batches of Kangjun Xiaoyan tablets(capsules)were established,and their similarity was calculated by the“Chinese medicine chromatographic fingerprint similarity evaluation system”(2012 Edition).Results The similarity of DAD(254 nm)fingerprints of the 11 batches of Kangjun Xiaoyan tablets(capsules)ranges from 0.900 to 0.992,and the similarity of CAD fingerprints of the 11 batches of Kangjun Xiaoyan tablets(capsules)ranged from 0.831 to 0.985.Totally 34 and 21 common peaks were labeled under DAD(254 nm)and CAD,respectively.Totally 12 common peaks were identified by comparing with reference materials,including chlorogenic acid,mangiferin,luteolin-7-Oglucoside,3,5-O-dicaffeoylquinic acid,4,5-O-dicaffeoylquinic acid,baicalin,quercetin,baicalein,rhein,wogonin,emodin and timosaponin BⅡ.Conclusion The HPLC-DAD-CAD fingerprint can be used to evaluate the quality of Kangjun Xiaoyan tablets(capsules).
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