【摘要】：目的:建立益心舒片的HPLC指紋圖譜,為益心舒片的質(zhì)量評價提供方法。方法:樣品經(jīng)75%甲醇提取后,采用Waters Symmetry ShieildTMC18色譜柱(4.6 mm×250 mm,5μm)進(jìn)行檢測,以乙腈-0.5%甲酸水為流動相,梯度洗脫,流速1.0 m L·min~(-1),檢測波長260 nm,柱溫30℃。采用國家藥典委員會出版的"中藥色譜指紋圖譜相似度評價系統(tǒng)"(2012年版),對10批不同批次的益心舒片化學(xué)成分指紋圖譜進(jìn)行相似度計(jì)算,并且通過對照品比對及高效液相與質(zhì)譜聯(lián)用技術(shù)(HPLC-MS)對主要共有峰進(jìn)行指認(rèn)。結(jié)果:10批益心舒片指紋圖譜中有29個共有峰,各峰分離度良好,各批次間共有峰的相對保留時間RSD均1.0%,樣品間相似度均0.9,共指認(rèn)出12個峰。結(jié)論:該方法具有良好的精密度、重復(fù)性、穩(wěn)定性,各共有峰間分離度高,可用于益心舒片的質(zhì)量綜合評價。
[Abstract]:Objective: to establish the HPLC fingerprint of Yixinshu tablets and to provide a method for the quality evaluation of Yixinshu tablets. Methods: the samples were extracted with 75% methanol and detected on a Waters Symmetry ShieildTMC18 column (4.6 mm 脳 250 mm,5 渭 m). Acetonitrile-0.5% formic acid water was used as mobile phase, gradient elution was used, flow rate was 1.0 mL min~ (-1). The detection wavelength was 260 nm, and the column temperature was 30 鈩，

本文編號：2421021