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.
作者
米振清
Mi Zhenqing(Taian Food and Drug Inspection Center,Shandong Taian 271099,China)
出处
《中国药师》
CAS
2020年第5期950-954,共5页
China Pharmacist
