CAJ | 학술논문

采用 HPLC法建立甘露聚糖肽口服液中氨基酸指纹图谱。色谱条件为 Diamonsil C18柱（250 mm×4．6 mm，5μm），流动相：A相为乙腈-水（4∶1），B相为0．1 mol/L醋酸钠-乙腈（93∶7，pH6．4）；梯度洗脱；流速1．0 mL/min；检测波长254 nm。以异硫氰酸苯酯为衍生化试剂，对来自3个厂家共10批次产品进行色谱分析，建立甘露聚糖肽口服液指纹图谱。精密度、重现性、稳定性试验 RSD均不大于3％。未水解甘露聚糖肽口服液指纹图谱共有11个峰，水解后指纹图谱共有11个峰，样品相似度均在0．90以上。研究结果表明，本方法稳定、准确，可为控制甘露聚糖肽口服液的质量提供参考。
채용 HPLC법건립감로취당태구복액중안기산지문도보。색보조건위 Diamonsil C18주（250 mm×4．6 mm，5μm），류동상：A상위을정-수（4∶1），B상위0．1 mol/L작산납-을정（93∶7，pH6．4）；제도세탈；류속1．0 mL/min；검측파장254 nm。이이류청산분지위연생화시제，대래자3개엄가공10비차산품진행색보분석，건립감로취당태구복액지문도보。정밀도、중현성、은정성시험 RSD균불대우3％。미수해감로취당태구복액지문도보공유11개봉，수해후지문도보공유11개봉，양품상사도균재0．90이상。연구결과표명，본방법은정、준학，가위공제감로취당태구복액적질량제공삼고。
Determination of fingerprint and technical parameter of amino acids in mannatide oral solution were conducted with high performance liquid chromatography method.Chromatographic conditions:Separa-tions were performed on a Diamonsil C18 column (250 mm×4.6 mm,5μm),Mobile phase A:acetonitrile-water(4∶1),mobile phase B:0.1 mol/L acetate-acetonitrile(93∶7,pH6.4);gradient elution;flow rate:1.0 mL/min;detection wavelength:254 nm.With phenylisothiocyanate as derivative agent,ten samples from different mannatide oral solution of three factory were analyzed and evaluated,the fingerprint of ami-no acids in mannatide oral solutions were determinated.The relative standard deviation (RSD)of precision and reproducibility was not more than 3%.There were 1 1 cornmorl peaks in non-hydrolyzed sample of fin-gerprint,1 1 conllnon peaks in hydrolyzed sample of fingerprint.The similarity of samples was all above 0.90.The result showed that the method is accurate,convenient,stable,and the chromatographic finger-prints can be served as a powerful tool for the further quality control of mannatide oral solution.