基于指纹图谱及多指标成分定量的通便灵胶囊质量评价  

Quality Evaluation of Tongbianling Capsules Based on Fingerprint and Quantitative Analysis of Multi-components

作　　者：蔡杨靖 潘云 Cai Yangjin;Pan Yun(The Second Affiliated Hospital of Hainan Medical College,Haikou 570100,China)

机构地区：[1]海南医学院第二附属医院,海口570100

出　　处：《中国药师》2019年第5期831-834,共4页China Pharmacist

摘　　要：目的:建立通便灵胶囊的HPLC指纹图谱和同时测定番泻叶苷A、番泻叶苷B、毛蕊花糖苷、松果菊苷及异毛蕊花糖苷含量的方法,为通便灵胶囊的质量控制提供可靠的参考。方法:采用SHIMADZU VP-ODS(250 mm×4. 6 mm,5μm)色谱柱,以乙腈-甲醇(1∶1)与0. 3%冰醋酸溶液作为流动相进行梯度洗脱,流速为0. 8 ml·min-1,柱温为30℃,切换波长270 nm及340 nm。建立通便灵胶囊指纹图谱,采用《中药色谱指纹图谱相似度评价系统》(2004A版)确定共有峰,计算相似度;并对番泻叶苷A、番泻叶苷B、毛蕊花糖苷、松果菊苷及异毛蕊花糖苷的含量测定方法进行方法学验证。结果:10批通便灵胶囊指纹图谱标定了共有峰16个,通过与混合对照品比较指认其中5个指标成分分别为番泻叶苷A、番泻叶苷B、毛蕊花糖苷、松果菊苷及异毛蕊花糖苷,利用相似度软件对10批样品指纹图谱进行分析,各批样品相似度均在0. 98以上。上述5个有效成分含量测定方法经验证,线性范围分别为3. 554～88. 850μg·ml^(-1),4. 268～106. 700μg·ml^(-1),6. 751～168. 700μg·ml^(-1),8. 966～224. 100μg·ml^(-1),7. 247～181. 100μg·ml^(-1),r≥0. 999 7;平均回收率分别为99. 3%(RSD=0. 5%)、100. 2%(RSD=0. 8%)、101. 1%(RSD=1. 0%)、100. 6%(RSD=0. 7%)和98. 9%(RSD=0. 4%)(n=6)。结论:本文所建立的通便灵胶囊HPLC指纹图谱及主要成分含量测定方法,能全面反映其内在质量,可用于通便灵胶囊的质量控制。Objective:To establish an HPLC fingerprint of Tongbianling capsules and simultaneously determine the contents of sennoside A,sennoside B,verbascoside,echinacoside and calycosin7-O-β-D-glucopyranoside,so as to provide reliable reference for the quality control of Tongbianling capsules.Methods:The analysis was carried out on an analytical column SHIMADZU VP-ODS(250 mm×4.6 mm,5μm)with gradient elution by acetonitrile methanol(1∶1)-0.3%glacial acetic acid solution at the detection wavelength of 270 nm and 340 nm with the flow rate of 0.8 ml·min^-1.The column temperature was 30℃.The fingerprint of Tongbianling capsules was established,the common peaks were determined by Similarity Evaluation System for Chromatographic Fingerprint of TCM(version 2004 A),and the similarity was calculated.The content determination methods for sennoside A,sennoside B,staminoside,echinarin and isostaminoside were validated.Results:There were 16 common peaks in the fingerprints of 10 batches of Tongbianling capsules,and 5 of them were identified by comparison with the references.The similar degrees of the 10 batches of samples were over 0.98.The linear range of sennoside A,sennoside B,verbascoside,echinacoside and calycosin7-O-β-D-glucopyranoside was3.554-88.850μg·ml^-1,4.268^-106.700μg·ml^-1,6.751^-168.700μg·ml^-1,8.966-224.100μg·ml^-1 and 7.247^-181.100μg·ml^-1(r≥0.999 7),respectively.The average recovery was 99.3%(RSD=0.5%),100.2%(RSD=0.8%),101.1%(RSD=1.0%),100.6%(RSD=0.7%)and 98.9%(RSD=0.4%)(n=6),respectively.Conclusion:The HPLC fingerprint of Tongbianling capsules by HPLC and the content determination methods for the main components can fully reflect their internal quality,which can be used for the quality control of Tongbianling capsules.

关 键 词：通便灵胶囊 番泻叶苷A 番泻叶苷B 毛蕊花糖苷 松果菊苷 异毛蕊花糖苷 指纹图谱 含量测定 高校液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]