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目的:建立贞芪扶正颗粒的高效液相色谱(HPLC)指纹图谱。方法:采用高效液相色谱-蒸发光散射检测法(HPLC-ELSD)。色谱柱为Agilent Zorbax Eclipse XDB-C18,流动相为乙腈-水(梯度洗脱),流速为1.0 mL/min,柱温为40 ℃,检测器蒸发光温度为50 ℃,进样量为10 μL。以特女贞苷为参照,测定7批贞芪扶正颗粒的HPLC图谱,采用《中药色谱指纹图谱相似度评价系统》(2004 A)版进行共有峰指认和相似度评价。结果:7批贞芪扶正颗粒的HPLC图谱有13个共有峰。经验证,7批样品HPLC图谱中有3批样品相似度>0.9,与对照指纹图谱具有较好一致性;4批样品相似度<0.9,与对照指纹图谱一致性较差。结论:该研究所建指纹图谱可为贞芪扶正颗粒的质量评价提供参考。
OBJECTIVE: To establish HPLC fingerprint of Zhenqi fuzheng granules. METHODS: HPLC-ELSD method was adopted. The determination was performed on Agilent Zorbax Eclipse XDB-C18 column with mobile phase consisted of acetonitrile-water (gradient elution) at the flow rate of 1.0 mL/min with column temperature of 40 ℃. The detector evaporation temperature was 50 ℃, and sample size was 10 μL. Using specnuezhenide as reference, HPLC chromatograms of 7 batches of Zhenqi fuzheng granules were determined. The identification and similarity evaluation of common peaks were conducted by using the TCM Chromatographic Fingerprint Similarity Evaluation System (2004 A edition). RESULTS: There were 13 common peaks in HPLC chromatograms of 7 batches of samples. After validated, the similarity of 3 batches of samples in HPLC chromatograms of 7 batches of samples were higher than 0.9, which were in good agreement with control fingerprints. The similarity of 4 batches of samples were <0.9,which were poorly same to control fingerprint. CONCLUSIONS: Established fingerprint can provide reference for quality evaluation of Zhenqi fuzheng granules.
贞芪扶正颗粒高效液相色谱-蒸发光散射检测法指纹图谱质量标准
Zhenqi?fuzheng?granulesHPLC-ELSDFingerprintQuality standard
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