CAJ | 학술논문

目的：建立金乌骨通胶囊的高效液相色谱指纹图谱分析方法，为金乌骨通胶囊药品质量评价积累数据。方法：采用反相高效液相色谱方法，以安捷伦Eclipse plus C18色谱柱（4．6mm ×250mm，5μm）；流动相为乙腈（A）－1％冰醋酸水溶液（B），梯度洗脱程序为：0～15min，9～10％A，流速1．0ml／min；15～65min，10～40％A，流速1．0ml／min；65～115min，40～70％A，流速1．5ml／min；115～125min，70％A，流速1．5ml／min；检测波长为0～60min 为254nm，60～85min 为380nm，85～125min 为254nm；洗脱总时间为125min；柱温30℃；进样量20μl，进行指纹图谱研究。结果：建立金乌骨通胶囊高效液相指纹图谱，以淫羊藿苷色谱峰为参照峰，确定13个共有峰，共测定29批样品，样品指纹图谱的相似度均大于0．985。结论：本方法分离效果好，精密度、稳定性、重现性等指标均良好，可用于金乌骨通胶囊的产品质量控制及市场真伪品鉴别。
목적：건립금오골통효낭적고효액상색보지문도보분석방법，위금오골통효낭약품질량평개적루수거。방법：채용반상고효액상색보방법，이안첩륜Eclipse plus C18색보주（4．6mm ×250mm，5μm）；류동상위을정（A）－1％빙작산수용액（B），제도세탈정서위：0～15min，9～10％A，류속1．0ml／min；15～65min，10～40％A，류속1．0ml／min；65～115min，40～70％A，류속1．5ml／min；115～125min，70％A，류속1．5ml／min；검측파장위0～60min 위254nm，60～85min 위380nm，85～125min 위254nm；세탈총시간위125min；주온30℃；진양량20μl，진행지문도보연구。결과：건립금오골통효낭고효액상지문도보，이음양곽감색보봉위삼조봉，학정13개공유봉，공측정29비양품，양품지문도보적상사도균대우0．985。결론：본방법분리효과호，정밀도、은정성、중현성등지표균량호，가용우금오골통효낭적산품질량공제급시장진위품감별。
Objective To establish the HPLC fingerprint of Jingwugutong Capsules and accumulate data for evaluation of its quali-ty.Methods The chromatographic fingerprints were determined with RP-HPLC on Agilent Eclipse plus C18 (4. 6mm ×250mm, 5μm)and with the gradient solvent system consisting of acetonitrile (A)and 1% AcOH solution (B),0 ~15min,9 ~10%A, flow rate 1. 0ml/min;15 ~65min,10 ~40%A,flow rate 1. 0ml/min;65 ~115min,40 ~70%A,flow rate 1. 5ml/min;115 ~125min,70%A,flow rate 1. 5ml/min;the detection wavelength was set at:0 ~60min 254nm,60 ~85min 380nm,85 ~125min 254nm,and the column temperature was maintained at 30℃.Results Based on the peaks of icariin as reference peak,measured val-ue of twenty nine batches revealed that there were thirteen common peaks and high similarity between samples of fingerprints.Conclu-sion It is easy to handle for this method and has good separation effect,reproducibility,stability,precision,and can be applied to the quality control and the authenticity identification of Jingwugutong Capsules.