夏天无注射液的HPLC指纹图谱的研究

Study on Fingerprint chromatogram of Corydalis decumbens for Injection

目的:研究建立夏天无注射液的指纹图谱。方法:采用反相高效液相色谱法,使用 Diamonsil C_(18)色谱柱(250 mm×4.6mm,5μm);流动相 A:乙腈,流动相 B:三乙胺醋酸溶液(每1000 mL 水中加入冰醋酸30 mL,三乙胺8 mL),进行梯度洗脱,流速:1.0 mL·min^(-1),柱温:25℃,检测波长280 nm。结果:利用2004年 A 版《中药色谱指纹图谱相似度评价系统》计算软件,生成了夏天无注射液的对照图谱,共有10个特征峰,各峰的分离度较好,符合指纹图谱检测要求。结论:采用 HPLC 指纹图谱技术可以有效地控制夏天无注射液的质量。

objective：To study and establish the fingerprint chromatogram of Corydalis decumbens Pers Injection. Methods ： RP - HPLC was adopted and the detector wavelength was set at 280 nm, HPLC analytical column was Di- amonsil C18（250mm×4.6mm,5μm）at 25℃, with a gradient of the following solvent mixtures：solvent A, aceto- nitrile;solventB, acetic acid triethylamine （dissolve 30 mL acetic acid in 1000 mL of water, add 8 mL triethyl- amine）. The flow rate was 1.0 mL·min^-1. Results：The standard fingerprints of Corydalis decumbens Pers Injection was originated from the similarity evaluation for chromatographic fingerprint of TCM （Version 2004 A） , and 10 common peaks existed in the fingerprint. Each accuracy, stability and repeatability, satisfied to the requests of finger- print. Conclusion：The RP - HPLC fingerprint method can be used in the quality control of Corydalis decumbens Pers Injection.