桂龙咳喘宁胶囊HPLC指纹图谱研究及7个活性成分的测定  

HPLC Fingerprint of Guilong Kechuanning Capsules and Content Determination of Seven Main Components

作　　者：米振清 Mi Zhenqing(Taian Food and Drug Inspection Center,Shandong Taian 271099,China)

机构地区：[1]泰安市食品药品检验检测中心,山东泰安271099

出　　处：《中国药师》2020年第5期950-954,共5页China Pharmacist

摘　　要：目的:建立桂龙咳喘宁胶囊的指纹图谱,并进行多成分定量分析,为评价其质量提供依据。方法:采用Kromasil C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速为1.0 ml·min-1,检测波长为235 nm(芍药内酯苷、甘草苷、芍药苷)、275 nm(肉桂酸、甘草素、桂皮醛、甘草酸铵),柱温为30℃。通过相似度对12批次桂龙咳喘宁胶囊指纹图谱进行质量评价,并对指认的7个指标成分进行定量测定研究。结果:12批桂龙咳喘宁胶囊指纹图谱标定了共有峰21个,通过与混合对照品比较指认了其中7个指标成分,利用相似度软件对12批样品指纹图谱进行分析,各批样品相似度均在0.99以上。芍药内酯苷、芍药苷、甘草苷、肉桂酸、甘草素、桂皮醛和甘草酸铵线性范围分别为2.020~40.400μg·ml-1(r=0.9994)、62.024~1240.480μg·ml-1(r=0.9998)、7.244~144.880μg·ml-1(r=0.9986)、1.206~24.120μg·ml-1(r=0.9992)、1.050~21.000μg·ml-1(r=0.9986)、0.100~2.000μg·ml-1(r=0.9990)、15.064~301.280μg·ml-1(r=0.9998)。结论:所建立的方法灵敏度高,专属性强,可用于桂龙咳喘宁胶囊的质量控制。Objective:To establish an HPLC fingerprint and determine 7 compounds of Guilong Kechuanning capsules to provide reference for the effective quality control.Methods:The analysis was carried out on a Kromasil C18(250 mm×4.6 mm,5μm)column with gradient elution by acetonitrile(A)-0.1%phosphoric acid solution(B)at the detection wavelengths of 235 nm(albiflorin,liquiritin and paeoniflorin)and 275 nm(cinnamic acid,liquiritigenin,cinnamaldehyde and ammonium glycyrrhetate).The flow rate was 1.0 ml·min-1.The column temperature was 30℃.Similarity was used to evaluate the fingerprints of 12 batches of Guilong Kechuanning capsules,and 7 marker components were quantified.Results:There were 21 common peaks in the fingerprints of the 12 batches of Guilong Kechuanning capsules,and 7 of them were identified by comparison with the references.The similar degrees of the 12 batches of samples were over 0.99.The linear range of albiflorin,paeoniflorin,liquiritin,liquiritigenin,cinnamic acid,cinnamaldehyde and ammonium glycyrrhetate was 2.020-40.400μg·ml-1(r=0.9994),62.024-1240.480μg·ml-1(r=0.9998),7.244-144.880μg·ml-1(r=0.9986),1.206-24.120μg·ml-1(r=0.9992),1.050-21.000μg·ml-1(r=0.9986),0.100-2.000μg·ml-1(r=0.9990)and 15.064-301.280μg·ml-1(r=0.9998),respectively.Conclusion:The established method has high sensitivity and specificity,and can be used for the quality control of Guilong Kechuanning capsules.

关 键 词：桂龙咳喘宁胶囊 高效液相色谱法 指纹图谱 相似度分析 含量测定 

分 类 号：TQ460.7[化学工程—制药化工]