目的 建立冠心苏合丸（Guanxin Suhe Pill，GXSHP）HPLC内标定量指纹图谱，用内标定量指纹图谱法选出冠心苏合丸对照制剂，为冠心苏合丸的质量控制提供对照制剂控制法。方法 采用Agilent Poroshell 120 SB C₁₈色谱柱（150 mm×4.6 mm，2.7 μm），流动相为水-甲醇（均含0.2%醋酸），梯度洗脱，体积流量0.5 mL/min，柱温（25.00±0.15）℃，紫外检测波长为275 nm，进样量5 μL。采用内标定量指纹法整体鉴定12批次GXSHP（S1～S12）质量，根据本方法评价结果选出冠心苏合丸对照制剂。结果 以内标物峰为参照峰，确定36个共有指纹峰，以加入固定浓度内标为基准建立了GXSHP-HPLC内标定量指纹图谱。用内标定量指纹法鉴别出S3、S5～S7、S9质量极好，S4、S8、S10、S11质量很好，S1、S2质量好，S12质量为劣，根据该方法评价结果，最终确定S3、S5～S7、S9可作为冠心苏合丸对照制剂。结论 内标定量指纹法可以减少对照品的使用，校正指纹图谱变化，提高测定结果的准确性，选出的对照制剂生成冠心苏合丸对照制剂指纹图谱可用于大批量冠心苏合丸的质量控制，具有重大的实际应用意义。

Objective To establish the Guanxin Suhe Pill (GXSHP)-HPLC internal standard quantified fingerprints method (ISQFM) for selecting the reference preparation of GXSHP by ISQFM and providing the quality control method of reference preparation. Methods Agilent Poroshell 120 SB C₁₈ column (150 mm × 4.6 mm，2.7 μm), 0.2% ethylic acid-water, and 0.2% ethylic acid-methanol were used as the mobile phases that were eluted with liner program. The flow rate was 0.5 mL/min, the UV absorbance was monitored at 275 nm by injecting 5 μL of the sample solution each time, and the column temperature was maintained at (25.00 ± 0.15) ℃. The ISQFM was used to identify the quality and select the reference preparation. Results The 36 common peaks were marked by choosing IS as the referential peaks and the quality of 12 batches of GXSHPs was identified by the ISQFM. The identification results were that the quality of five batches (S3, S5—S7, and S9) were best, four batches (S4, S8, S10, and S11) were better, two batches (S1 and S2) were good, and one batch (S12) was lower than good, according to the results of this method, S3, S5— S7, and S9 could be used as the reference preparation of GXSHPs. Conclusion This method could reduce the use of reference substances and improve the accuracy of the measured results. The reference preparation of GXSHPs, which is selected by this method, could be used for the quality control of large quantities of GXSHPs with the great significance in practical production.

国家自然科学基金重大研究计划项目（No.90612002）