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目的研究丹参胶囊水溶性成分的高效液相色谱指纹图谱。方法制备丹参胶囊检测样品以及主要成分对照品,使用Agilent 1100高效液相色谱仪,Chemistationrev色谱工作站,C18色谱柱,以含有0.1%三氟乙酸的水溶液为水相,乙腈为有机相,柱温25℃,检测器检测波长254 nm。流动相中乙腈的体积分数在70 min内由0逐渐增加到70%进行梯度洗脱,流动相的流速固定为1.00 ml/min。结果方法学实验研究结果表明本研究办法符合国家药品监督管理局的相关标准,供试胶囊的特征性色谱峰为1号、2号、5号、7号峰。结论本研究所建立的丹参胶囊水溶性成分的高效液相色谱指纹图谱操作明确、稳定性良好、精密度高,可以应用于丹参胶囊水溶性成分的相关质量分析研究。
Objective To study the HPLC fingerprint of water-soluble components of Danshen capsule. Methods Salviae miltiorrhizae capsules were prepared and the main components of reference substance were prepared. The samples were separated on an Agilent 1100 HPLC Chemistationrev chromatography workstation and C18 column. The aqueous solution containing 0.1% trifluoroacetic acid was used as the water phase. Acetonitrile was the organic phase and the column temperature was 25 ℃, detector detection wavelength 254 nm. The volume fraction of acetonitrile in the mobile phase was gradually increased from 0 to 70% within 70 min. The mobile phase was eluted with a gradient of 1.00 ml / min. Results The results of the methodological experiment showed that this research method conformed to the relevant standards of the State Drug Administration. The characteristic chromatographic peaks of the capsules tested were No. 1, No. 2, No. 5 and No. 7. Conclusion The HPLC fingerprint of water-soluble constituents of Salvia miltiorrhiza capsule established in this study has clear operation, good stability and high precision. It can be applied to the related quality analysis of water-soluble components of Salvia miltiorrhiza capsules.