中药复方制剂仙灵骨葆胶囊HPLC指纹图谱研究

HPLC Fingerprint of Xianling Gubao Capsule,a TCM Prescription

目的建立中药复方仙灵骨葆胶囊的HPLC指纹图谱,对市售制剂进行质量控制。方法采用C18色谱柱(4.6 mm×250 mm,5μm),以乙腈-水(各含体积分数为0.1%的甲酸)为流动相进行梯度洗脱,流速0.80 mL.min-1,检测波长270 nm,柱温35℃;建立仙灵骨葆胶囊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28批市售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。结果建立的仙灵骨葆胶囊HPLC指纹图谱的专属性、精密度、重现性和稳定性均良好;28批市售制剂的指纹图谱与对照指纹图谱的相似度值在0.952～0.995之间;覆盖该复方六味组方中药的27个主要特征峰得到明确的化学指认、指认峰面积约占总峰面积的70%。结论上述建立的主要特征峰化学成分明确的HPLC指纹图谱基本全面反映该中药复方制剂中各味组方中药、多成分的整体特征,可以用于市售产品的质量评价。以上工作可为提高仙灵骨葆整体质量控制方法提供实验依据。

OBJECTIVE To establish the HPLC fingerprint of Xianling Gubao capsule （XLGB） , a traditional Chinese medicineprescription in market coupled with similarity assay for the quality control of its products. METHODS The separation was developed on a C18 column （4. 6 mm × 250 mm, 5 μm） by gradient elution with acetonitrile-water（ both containing 0. 1% （WV） formic acid） asthe mobile phase, flow rate at 0. 80 mL · min^-1, detection wavelength at 270 nm and column temperature at 35 ℃. An HPLC fingerprint of XLGB was set up and the quality of 28 batches of XLGB was evaluated by similarity assay. Furthermore, the main characteris-tic peaks in HPLC fingerprint of XLGB were identified by comparing the retention time with those of chemical reference substances and were assigned preliminarily to the individual herbs. RESULTS The established HPLC fingerprint of XLGB was specific, precise, re-producible and stable. The similarity of 28 batches of XLGB was about 0. 952 to 0. 995. Twenty-seven main characteristic peaks from six herbs of XLGB were chemically identified, which occupied 70% peak area of all the main peaks. CONCLUSION The estab-lished HPLC fingerprint with chemically identified main characteristic peaks represented the profile of XLGB and can be used for quality evaluation of its products. The above work can provide the experimental basis to improve overall quality control of XLGB.