本文選題：中藥復(fù)方制劑　切入點：牛黃鎮(zhèn)驚丸　出處：《分析試驗室》2017年12期

【摘要】：建立牛黃鎮(zhèn)驚丸指紋圖譜分析方法以評價該制劑質(zhì)量。采用C18(4.6 mm×250 mm,5μm)為色譜柱,乙腈-0.2%甲酸為流動相梯度洗脫,采用HPLC-DAD-ELSD聯(lián)用法建立UV254 nm與ELSD雙通道指紋圖譜。對2家生產(chǎn)企業(yè)的8批牛黃鎮(zhèn)驚丸進行相似度評價,并對部分色譜峰進行鑒定。在選定的色譜條件下,相似度評價結(jié)果表明不同企業(yè)產(chǎn)品間存在一定差異,通過對照品比對確認了指紋圖譜中15個色譜峰(天麻素、對羥基苯甲醇、升麻素苷、甘草苷、升麻素、5-O-甲基維斯阿米醇、廣防風(fēng)苷A、亥茅酚苷、牛磺膽酸、甘氨膽酸、甘草酸銨、膽酸、豬去氧膽酸、鵝去氧膽酸和去氧膽酸)。建立的牛黃鎮(zhèn)驚丸HPLC-DAD-ELSD指紋圖譜分析方法為進一步提高本品質(zhì)量標準提供了科學(xué)依據(jù)。
[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.
【作者單位】： 中國食品藥品檢定研究院;
【基金】：國家十二五“重大新藥創(chuàng)制”專項(2014ZX09304307-002)資助
【分類號】：O657.72;R286.0
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本文編號：1675044