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目的:建立中药复方骨疏灵的HPLC特征指纹图谱,确定全方HPLC图谱中各特征峰的来源。方法:采用Cosmosil C18色谱柱(4.6 mm×250 mm,5μm),以乙腈-0.1%磷酸盐水溶液为流动相进行梯度洗脱,流速为1.0ml·min-1,柱温30℃,进样量20μl,检测波长260 nm,建立骨疏灵HPLC特征指纹图谱,运用中药色谱指纹图谱相似度评价系统(国家药典委员会2004A版)进行相似度评价;通过对全方、缺味组方以及单味药材的HPLC图谱进行对比分析确定全方HPLC图谱中各特征峰的来源。结果:建立骨疏灵HPLC特征图谱的精密度、重复性和稳定性均良好,确定了20个共有特征指纹峰,20个共有特征指纹峰中淫羊藿贡献最多为16个,10批骨疏灵自制制剂的相似度评价虽有差别但色谱行为一致。结论:建立的骨疏灵HPLC特征指纹图谱可为骨疏灵的质量标准制定以及骨疏灵的药效物质基础研究提供参考依据。
OBJECTIVE: To establish HPLC fingerprint of traditional Chinese medicine Gushuling and determine the source of each characteristic peak in the full-spectrum HPLC. Methods: Cosmosil C18 column (4.6 mm × 250 mm, 5 μm) was used for gradient elution with acetonitrile-0.1% phosphate aqueous solution as the mobile phase at a flow rate of 1.0 ml · min-1 with a column temperature of 30 ℃. 20μl, detection wavelength 260 nm, the establishment of sour sparse HPLC fingerprint characteristics, the use of Chinese medicine chromatographic fingerprint similarity evaluation system (State Pharmacopoeia Commission 2004A version) for similarity evaluation; through the whole party, HPLC comparison of the HPLC analysis to determine the source of all the characteristic peaks in the HPLC. Results: The precision, repeatability and stability of HPLC fingerprint of sarcoplasmic acid were all established well, and 20 common fingerprint peaks were identified. Epimedium contributed up to 16 in 20 common fingerprint peaks, Ling homemade preparations of similarities in the evaluation of the difference but the chromatographic behavior of the same. Conclusion: The established HPLC fingerprint of sarcoplasmic acid can provide a reference for establishing the quality standard of sarcophagus and the basic research of pharmacodynamics of sarcophagus.