脑心通胶囊HPLC-DAD指纹图谱研究

HPLC-DAD fingerprint of Naoxintong capsules

目的建立脑心通胶囊HPLC-DAD指纹图谱分析方法,对复方中主要特征峰进行归属和指认。方法采用Waters SunFire C_(18)色谱柱(5μm,4.6 mm×250 mm),乙腈-0.1%甲酸,柱温30℃,流速1.0 mL·min^(-1),进样量5μL,进行梯度洗脱;采用中药指纹图谱相似度评价系统(2004A版)进行相似度评价;将脑心通胶囊高效液相色谱指纹图谱与各单味药高效液相色谱指纹图谱进行比对,利用色谱峰保留时间确定脑心通胶囊主要色谱峰来源归属。结果 15批脑心通胶囊相似度均≥0.977,表明脑心通胶囊化学成分一致性良好;脑心通胶囊HPLC-DAD指纹图谱中共检出33个特征峰,均可以溯源到黄芪、赤芍、丹参等12味药材,其中13个特征峰可以明确其化学成分归属。结论建立的脑心通HPLCDAD指纹图谱分析方法,操作简单、准确,精密度、重复性好,可用于表征脑心通胶囊中化学成分信息,提高了对大复方制剂质量控制的专属性,为脑心通胶囊质量控制提供了可靠的科学依据。

Objective To establish an HPLC-DAD fingerprint for Naoxintong capsules(NXTC). Methods HPLCDAD fingerprint of NXTC was obtained with Waters SunFire C18 column(5 μm, 4.6 mm×250 mm) and nonlinear elution, with the mobile phase consisting of acetonitrile-0.1% methanoic acid, column temperature at 30℃, and injection volume at 5 μL. Totally 15 batches of NXTC were evaluated with similarity evaluation system for chromatographic fingerprints of traditional Chinese medicine. The liquid chromatographic fingerprints of the NXTC and each drug were compared. The main chromatographic peaks of NXTC were classified and characterized by the relative retention time of the chromatographic peaks. Results The similarity of NXTC was greater than 0.977, indicating good consistency of NXTC chemical components. The NXTC HPLC fingerprints consisted of 33 peaks, which were recognized by parallel comparison with the fingerprints of the 12 corresponding crude drugs in the formula and 13 peaks were identified by comparison with the chemical reference substances. Conclusion The established HPLC-DAD fingerprints represent the character of NXTC, and enhance the specificity for quality control and assessment of the product.