目的: 将一测多评方法应用于肿节风注射液中新绿原酸、绿原酸、隐绿原酸、咖啡酸、异嗪皮啶、迷迭香酸6个成分的HPLC含量测定，并建立其方法学的考察模式。方法: 以乙腈(A)-0.1%甲酸(B)为流动性，梯度洗脱(0~8 min，8%A；8~60 min，8%A→30%A；60~75 min，8%A)，流速1.0 mL·min-1，柱温30℃，检测波长330 nm。在一定的线性范围内以异嗪皮啶为对照品，建立肿节风注射液中该成分与新绿原酸、绿原酸、隐绿原酸、咖啡酸、迷迭香酸的相对校正因子(分别为1.0657、1.0559、1.0621、1.8497、0.8797)，利用相对校正因子计算新绿原酸、绿原酸、隐绿原酸、咖啡酸、迷迭香酸的含量，同时用外标法测定6个成分的绝对含量；以验证一测多评的准确性和科学性。结果: 建立的校正因子经不同厂家的仪器及色谱柱在不同的实验室考察，重现性良好，肿节风注射液中采用校正因子计算的含量与外标法实测值之间没有明显差异(P>0.05)，且2种方法所得的含量值相对偏差都在3%以内。结论: 在对照品缺乏的情况下，该方法可以作为新模式用于中药制剂的多成分定量，为肿节风注射液的多指标质量评价及控制提供科学依据。
Objective: To establish a new quality evaluation method for Zhong-Jie-Feng injection using single marker (QAMS) of HPLC for determination of six components (neochlorogenic acid,chlorogenic acid,4-dicaffeoylquinic acid,caffeic acid,isofraxidin,rosmarinic acid).Methods: The mobile phase consisted of acetonitrile (A) and 0.1% methanoic acid solution (B) with gradient elution (0-8 min,8%A;8-60 min,8%A→30%A;60-75 min,8%A) at the flow rate of 1.0 mL·min-1;the column temperature was set at 30℃,and the UV detection wavelength was at 330 nm.In certain linear range,isofraxidin was selected as the internal reference substance,the relative correction factors (RFC) of neochlorogenic acid,chlorogenic acid,4-dicaffeoylquinic acid,caffeic acid and rosmarinic acid were calculated,the values of RFC were 1.0657,1.0559,1.0621,1.8497,0.8797 respectively.The contents of six components in samples were determined by both external standard method and QAMS.The validity of the QAMS method was evaluated by comparison of their quantitative results.Results: Good reproducibility of the RFC had verified by using instruments and chromatographic column of different manufacturers in different laboratories.No significant differences between the quantitative results of the above two methods were observed(P>0.05),deviation of the two methods of the content was within 3%.Conclusion: When standard substances are unavailable,the QAMS method can be used as a new quality assessment model for Zhong-Jie-Feng injection.
