三七及血塞通注射液特征图谱的质量控制研究

Rapid analysis by HPLC in the quality control study of Chinese herbal medicine pseudo-ginseng and its Chinese drugs preparation＇s specific chromatogram

目的采用HPLC快速法分析不同产地三七药材及其中药制剂血塞通注射液中的5种皂苷成分并分析其指纹图谱特征。方法采用WatersNova-Pak-wat044375快速色谱分离柱（4．6mm×l50mm，4gm），以乙腈-0．5％甲酸溶液（v／v）系统为流动相，梯度洗脱，柱温30℃，检测波长203am。选择产自云南、四川、广西、江西等地的12批三七药材及4个不同厂家生产的血塞通注射液进行HPLC快速分析及方法学考察，采用“中药色谱指纹相似度评价系统（2012版）”进行相似度分析。结果建立快速HPLC指纹图谱在检测1min内出现基线分离，5种成分均可在40min内成功检出，各组分相似度超过0．9，并具有良好的精密度、稳定性及重现性，RSD均在5％N。结论HPLC快速分析法建立的三七药材及其制剂特征图谱方法简单、快速有效，可体现三七及其制剂中5种代表成分图谱的变化，可用于三七药材及其制剂的质量控制评价。

Objective To study the HPLC rapid analysis method for the 5 kinds of saponins in pseudo-ginseng herbs and its traditional Chinese medicine preparations Xuesaitong injection at different habitats and analyze the fingerprint characteristics. Methods The Waters Nova-Pak-wat044375 flash chromatography column （4.6 mm× 150 mm, 4 μm） was as stationary phase, and acetonitrile-0.5% formic acid solution （v/v） system was as the mobile phase. The gradient elution, column temperature was 30 ℃, and detection wavelength was of 203 nm. Twelve batches of Panax notoginseng in Yunnan, Sichuan, Guangxi, Jiangxi and other places four kinds of Xuesaitong injection from different manufacturers were taken for rapid analysis of HPLC and methodological study. The similarity analysis was carried out by Chinese medicine chromatographic fingerprint similarity evaluation system （2012 edition）. Results The establishment of rapid HPLC fingerprints baseline separation occurred within 1 min of detection, and 5 kinds of ingredients were all successfully detected in the 40 min. The similarity of each component was more than 0.9, and with a good precision, stability and reproducibility, RSD within 5%. Conclusions The method of HPLC rapid analysis for Chinese herbal medicine pseudo-ginseng and its Chinese drugs preparation＇s specific chromatogram is simple, rapid and effective. It can fully reflect the changes of 5 representative components chromatogram in pseudo-ginseng and its preparation, and so it can be as the quality control evaluation of pseudo-ginseng and its preparation.