积贝消肿胶囊指纹图谱及其含量测定的研究  

Study on Chromatography Fingerprint and Determination of Jibei Xiaozhong Capsules

作　　者：陆强[1] 李万红[1] 胡世强[2] 

机构地区：[1]宁夏医科大学总医院,宁夏银川750004 [2]广州市药品检验所,广东广州510160

出　　处：《中药新药与临床药理》2015年第3期369-372,共4页Traditional Chinese Drug Research and Clinical Pharmacology

摘　　要：目的建立积贝消肿胶囊指纹图谱及其含量测定的方法。方法样品经过甲醇超声提取后,过滤、进液相色谱仪测定,采用Alltech C18色谱柱分离;梯度洗脱;流速：1.0 m L·min-1;检测波长：205 nm;柱温：30℃。结果在指纹图谱中标示了15个共有峰,以5号峰为参照峰,2、3、6号峰面积接近或大于总峰面积的10%。并对色谱峰中主要的皂苷类成分进行了含量测定,在0.160~0.800 mg·L^-1浓度范围内,线性相关系数r〉0.9996,回收率均〉98%,方法学考察结果符合建立指纹图谱的技术要求及含量测定要求。结论应用HPLC指纹图谱结合主要皂苷类成分含量测定可以更好地控制积贝消肿胶囊制剂的质量。Objective To study the chromatography fingerprint and the determination of Jibei Xiaozhong Capsule.Methods The liquid phase chromatography was carried out after the samples were treated with methanol ultrasound extraction and filtration. The separation was performed on an Alltech C18 column with gradient elution. The flow rate was1.0 m L·min-1. UV detecting wavelength was at 205 nm,and column temperature was at 30 ℃. Results There were 15 common peaks shown in the HPLC fingerprint. Peak 5 was selected as the control peak,and the area of peak 2,3,6was close to or higher than 10 % of the total peak area. The linear range of the saponins was between 0.160 and0.800 mg·L^-1,r 0.9996. The recoveries were above 98 %. The results of method validation met the technical standard of fingerprints and content determination. Conclusion The HPLC fingerprinting combined with determination of the main saponins can be used to control the quality of Jibei Xiaozhong Capsule better.

关 键 词：积贝消肿胶囊 指纹图谱 含量测定 

分 类 号：R284.1[医药卫生—中药学]