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目的:建立苦木注射液的HPLC指纹图谱,并同时测定3种咔巴啉类生物碱的含量,全面评价其内在质量。方法:采用Phenomenex Gemini C18色谱柱(4.6 mm×250 mm,5μm),甲醇-30 mmol.L-1乙酸铵(冰乙酸调pH4.5)溶液梯度洗脱,用国家药典委员会“中药色谱指纹图谱相似度评价系统2004 A版”处理分析,建立苦木注射液的HPLC指纹图谱共有模式。结果:在指纹图谱研究中,标定了16个共有峰,指认了7个化合物,分析的11批苦木注射液与共有模式之间相似性良好,相似度均在0.9以上;3种咔巴啉类生物碱在含量分析测定条件下,各组分分离良好,相关系数均为0.999 9,线性范围分别为0.020 0～0.300 0,0.102 0～1.530 0,0.015 2～0.228 0μg,加样回收率在99.5%～102%。结论:本法灵敏度高、专属性强,HPLC指纹图谱结合多成分含量测定为苦木注射液的质量控制提供科学依据。
OBJECTIVE: To establish the HPLC fingerprinting of Momordicae injection and to simultaneously determine the content of three kinds of carbarboline alkaloids and evaluate their intrinsic quality. METHODS: A gradient elution was performed on a Phenomenex Gemini C18 column (4.6 mm × 250 mm, 5 μm) with a gradient of methanol-30 mmol.L-1 ammonium acetate (adjusted to pH 4.5 with glacial acetic acid). The chromatographic fingerprint Map similarity evaluation system 2004A version "processing analysis, the establishment of the common profile of HPLC fingerprint of bitter wood injection. RESULTS: In the fingerprint study, 16 common peaks were calibrated and 7 compounds were identified. The similarity between the 11 batches of bitter wood injection and the consensus model was good, and the similarities were all above 0.9. Three kinds of carboline The alkaloids were separated well under the conditions of content analysis and determination, the correlation coefficient was 0.999 9, the linear range was 0.020 0 ~ 0.300 0,0.102 0 ~ 1.530 0,0.015 2 ~ 0.228 0μg, the recovery rate was 99.5% ~ 102%. Conclusion: This method has high sensitivity and specificity, and provides a scientific basis for the quality control of Momordica Injection by HPLC fingerprinting combined with multi-component determination.