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目的建立中药复方肠泰浸膏的HPLC指纹图谱,以对该制剂进行质量控制。方法采用C_(18)色谱柱(250 mm×4.6mm,5μm),以甲醇-水(含0.05%磷酸)为流动相进行梯度洗脱,紫外检测波长270 nm,流速1.0 mL·min~(-1),建立复方肠泰浸膏HPLC指纹图谱。运用“中药色谱指纹图谱相似度评价系统软件”对16批在研制剂进行相似度评价,通过比对化学分离对照品的保留时间,对主要特征峰进行明确化学指认并初步确定组方中药来源。结果建立的复方肠泰浸膏HPLC指纹图谱的专属性、精密度、重复性和稳定性均良好;16批制剂的指纹图谱与对照品图谱的相似度值为0.948~0.999;覆盖该复方四味组方中药的6个主要特征峰均得到明确的化学指认,指认峰面积约占总峰面积的70%。结论所建立的HPLC指纹图谱表达了上述中药复方制剂中多组分的整体特征,可以用于该复方肠泰浸膏的质量评价。
OBJECTIVE To establish the HPLC fingerprints of traditional Chinese medicine intestine and intestine extract to control the quality of the preparation. Methods A gradient elution was performed on a C 18 column (250 mm × 4.6 mm, 5 μm) using methanol - water (containing 0.05% phosphoric acid) as the mobile phase. The detection wavelength was set at 270 nm and the flow rate was 1.0 mL · min ~ 1), the establishment of compound intestine and Thai extract HPLC fingerprint. Using “similarity evaluation system of chromatographic fingerprints of traditional Chinese medicine” to evaluate the similarity of 16 batches of developing agents, the main characteristic peaks were clearly identified and identified by comparing the retention time of chemosensors source. Results The HPLC fingerprints of Fufangchangtai extract showed good specificity, precision, repeatability and stability. The fingerprint similarity of the 16 batches of samples was 0.948-0.9999. The four prescriptions The six main characteristic peaks of the traditional Chinese medicine prescriptions were all clearly identified chemically, and the peak area was about 70% of the total peak area. Conclusion The established HPLC fingerprinting expresses the overall characteristics of the multi-component in the above traditional Chinese medicine compound preparation and can be used for the quality evaluation of the compound intestine extract.