三七药材、总皂苷及其制剂HPLC指纹图谱的研究

Study on fingerprints of radix notoginseng, total saponins and its preparation by HPLC method

[目的]采用高效液相色谱(HPLC)法对三七药材、三七总皂苷及血塞通氯化钠注射液进行指纹图谱研究,并分别对其相似度进行考察,为科学评价与有效控制血塞通氯化钠注射液提供方法。[方法]色谱条件:LunaC18柱(250mm×4.6mm,Ф5μm),乙腈-水二元梯度洗脱,检测波长203nm,流速1.0mL/min,柱温30℃,进样量20μL;并采用中药色谱指纹图谱相似度评价系统2004A版对其相似度进行分析。[结果]建立了三七药材、三七总皂苷及血塞通氯化钠注射液HPLC指纹图谱,且相似度较好。[结论]此方法能够作为三七药材、三七总皂苷及血塞通氯化钠注射液指纹图谱的检测标准,为全面控制血塞通氯化钠注射液质量提供了依据。

[Objective] To investigate the chromatographic fingerprints of Radix Notoginseng, total saponins and Xuesaitong Sodium Chloride Injection by HPLC, and observe their similarities respectively so as to establish a sensitive and specific method for controlling the quality of Xuesaitong Sodium Chloride Injection. [Methods] The analysis was carried out on Luna C18 column （250 mm×4.6 mm, Ф5 μm） and gradient elution of acetonitrile-water. The detection wavelength was at 203 nm, the flow rate was 1.0 mL/min, the column temperature was set at 30 ℃ and 20 μL sample was injected. The similarity was analyzed by SOP of similarity evaluation system for chromatographic fingerprint of TCM （Version 2004 A）. [Results] The HPLC fingerprints of Radix Notoginseng, total saponins and Xuesaitong Sodium Chloride Injection were obtained. The similarity was better. [Conclusions] This method can be used as the standards in testing the fingerprints of Radix Notoginseng, total saponins and Xuesaitong Sodium Chloride Injection, and has provided a eriteria in the quality control for Xuesaitong Sodium Chloride Injection.