目的 建立疏血通注射液中游離氨基酸的UPLC指紋圖譜分析方法。方法 采用異硫氰酸苯酯（PITC）衍生化方法，使用Waters Acquity超高效液相色譜儀，以CORTECS^® C₁₈柱（150 mm×2.1 mm，1.6 μm），乙腈-0.1%甲酸水進(jìn)行梯度洗脫，體積流量為0.1 mL/min，柱溫為25℃，進(jìn)樣量為2 μL，檢測(cè)波長(zhǎng)為254 nm。結(jié)果 33批不同批次疏血通注射液中有28個(gè)共有峰，其中有15個(gè)已知峰，分別為組氨酸（His）、精氨酸（Arg）、絲氨酸（Ser）、甘氨酸（Gly）、谷氨酸（Glu）、天冬氨酸（Asp）、蘇氨酸（Thr）、脯氨酸（Pro）、丙氨酸（Ala）、酪氨酸（Tyr）、甲硫氨酸（Met）、纈氨酸（Val）、亮氨酸（Leu）、賴氨酸（Lys）、苯丙氨酸（Phe），不同批次的樣品與標(biāo)準(zhǔn)指紋圖譜相似度均在0.994以上。結(jié)論 本實(shí)驗(yàn)建立的UPLC指紋圖譜分析方法穩(wěn)定、精密度高，可應(yīng)用于疏血通注射液的質(zhì)量控制和評(píng)價(jià)。

Objective To establish a UPLC fingerprint analysis method for free amino acids in Shuxuetong Injection.Methods Using phenyl isothiocyanate (PITC) derivatization method, using a Waters Acquity ultra performance liquid chromatograph, gradient elution with CORTECS^® C₁₈ column (150 mm×2.1 mm, 1.6 μm) in acetonitrile-0.1% formic acid water, the flow rate is 0.1 mL/min, column temperature is 25℃, the injection volume is 2 μL, and the detection wavelength is 254 nm.Results There are 28 common peaks in 33 batches of different batches of Shuxuetong Injection, including 15 known peaks, namely histidine (His), arginine (Arg), serine (Ser), glycine (Gly), glutamic acid (Glu), aspartic acid (Asp), threonine (Thr), proline (Pro), alanine (Ala), tyrosine (Tyr), methionine (Met), valine (Val), leucine (Leu), lysine (Lys), phenylalanine (Phe), the similarity of samples and standard fingerprints of different batches are above 0.994.Conclusion The UPLC fingerprint analysis method established in this experiment is stable and has high precision. It can be applied to the quality control and evaluation of Shuxuetong Injection.

國家自然基金項(xiàng)目（81673824，81503457）