葶苈生脉口服液的HPLC指纹图谱研究

Study on HPLC Fingerprints of Tingli Shengmai Oral Liquid

目的:建立葶苈生脉口服液的高效液相色谱(HPLC)指纹图谱。方法:采用HPLC法。色谱柱为YMC J’sphere ODS-H80,流动相为乙腈-0.1%磷酸溶液(梯度洗脱),流速为1.0 m L/min,检测波长为203、270 nm,柱温为30℃,进样量为30μL。以丹酚酸B为参照,绘制10批样品的HPLC图谱,采用《中药色谱指纹图谱相似度评价系统》(2004 A)进行相似度评价,确定共有峰。结果:10批样品的HPLC图谱在203 nm波长处有21个共有峰,在270 nm波长处有17个共有峰,相似度为0.981~0.999;经验证,10批样品的HPLC图谱与对照指纹图谱具有较好的一致性。结论:所建指纹图谱可为葶苈生脉口服液的质量控制提供参考。

OBJECTIVE:To establish HPLC fingerprints of Tingli shengmai oral liquid.METHODS:HPLC method was adopted.The determination was performed on YMC J’sphere ODS-H80 column with mobile phase consisted of acetonitrile-0.1%phosphoric acid solution(gradient elution)at the flow rate of 1.0 mL/min.The detection wavelengths were 203 nm and 270 nm,respectively.The column temperature was 30℃,and the sample size was 30μL.Using salvianolic acid B as reference,HPLC chromatograms of 10 batches of sample were established.TCM Chromatogram Fingerprint Similarity Evaluation System(2004 A)was used to evaluate the similarity so as to confirm common peak.RESULTS:There were 21 common peaks in HPLC chromatograms of 10 batches of samples at 203 nm,and 17 common peaks at 270 nm.The similarity was 0.981-0.999.After validation,HPLC chromatograms of 10 batches of sample were good in agreement with control fingerprint.CONCLUSIONS:Established fingerprints can provide reference for quality evaluation of Tingli shengmai oral liquid.