牛黄镇惊丸HPLC-DAD-ELSD指纹图谱研究

发布时间：2018-03-28 06:02

  本文选题：中药复方制剂　切入点：牛黄镇惊丸　出处：《分析试验室》2017年12期

【摘要】：建立牛黄镇惊丸指纹图谱分析方法以评价该制剂质量。采用C18(4.6 mm×250 mm,5μm)为色谱柱,乙腈-0.2%甲酸为流动相梯度洗脱,采用HPLC-DAD-ELSD联用法建立UV254 nm与ELSD双通道指纹图谱。对2家生产企业的8批牛黄镇惊丸进行相似度评价,并对部分色谱峰进行鉴定。在选定的色谱条件下,相似度评价结果表明不同企业产品间存在一定差异,通过对照品比对确认了指纹图谱中15个色谱峰(天麻素、对羟基苯甲醇、升麻素苷、甘草苷、升麻素、5-O-甲基维斯阿米醇、广防风苷A、亥茅酚苷、牛磺胆酸、甘氨胆酸、甘草酸铵、胆酸、猪去氧胆酸、鹅去氧胆酸和去氧胆酸)。建立的牛黄镇惊丸HPLC-DAD-ELSD指纹图谱分析方法为进一步提高本品质量标准提供了科学依据。
[Abstract]:A fingerprint analysis method was established to evaluate the quality of Niuhuang Zhenjing Pill. The chromatographic column was C184.6mm 脳 250mm ~ 5 渭 m, and acetonitrile-0.2% formic acid was used as mobile phase gradient elution. The two-channel fingerprints of UV254 nm and ELSD were established by HPLC-DAD-ELSD method. The similarity of 8 batches of Niuhuang Zhenjingwan from two manufacturing enterprises was evaluated, and some chromatographic peaks were identified. Under the selected chromatographic conditions, The results of similarity evaluation showed that there were some differences among products of different enterprises, and the 15 chromatographic peaks (Gastrodin, p-hydroxybenzyl methanol, glucoside, glycyrrhizin, pentasin 5-O- methyl Vasamitol) were confirmed by comparison of reference substances. Fangfangfangfanglein A, Helafenoside, taurocholic acid, glycyrrhizic acid, cholic acid, glycyrrhizic acid, cholic acid, porcine deoxycholic acid, The HPLC-DAD-ELSD fingerprint analysis method of chenodeoxycholic acid and deoxycholic acid provided scientific basis for further improving the quality standard of this product.
【作者单位】： 中国食品药品检定研究院;
【基金】：国家十二五“重大新药创制”专项(2014ZX09304307-002)资助
【分类号】：O657.72;R286.0
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本文编号：1675044