[关键词]
[摘要]
目的 采用高效液相色谱法建立注射用五味子提取物指纹图谱,并对2015—2016年制备的40批注射用五味子提取物进行指纹图谱相似度分析。方法 试验考察了不同流动相组成和浓度、不同检测波长、不同洗脱方法、不同品牌C18色谱柱(250 mm×4.6 mm,5 μm)、不同流速、不同柱温等条件下供试品溶液的色谱行为,利用中药色谱指纹图谱相似度评价系统对试验所得色谱图进行相似度分析。结果 确定了高效液相色谱检测条件,建立了20批注射用五味子提取物的对照指纹图谱(相似度不低于0.991),确定了12个共有峰,并对5个共有峰进行了指认,其余20批供试品与对照图谱的相似度均值为0.994。结论 本试验建立的注射用五味子提取物指纹图谱可以为其质量控制提供科学的依据,为完善注射用益气复脉(冻干)质量标准提供数据支持。
[Key word]
[Abstract]
Objective To establish the fingerprint analysis method of Fructus Schisandrae chinensis extract for injection by HPLC; To analyze the similarity on the fingerprints of Fructus Schisandrae chinensis extract of 40 Ses prepared from 2015 to 2016. Methods The experiments were conducted to evaluate the influence of chromatographic behavior:Different mobile phase composition and concentration, different detection wavelength, different elution methods, different brands of C18 columns (250 mm×4.6 mm, 5 μm), different flow rates and different column temperatures, etc. Similarity degree analysis of experimental chromatograms by similarity evaluation system of chromatographic fingerprint of traditional Chinese Medicine. Results The detection conditions of HPLC were determined, established the reference fingerprint with the 20 Ses of Fructus Schisandrae chinensis extract samples (the similarity is not less than 0.991), among which 12 peaks were common fingerprint peaks, and 5 main compounds were identified. The average similarity between the other 20 Ses of samples and the reference fingerprint was 0.994. Conclusion The fingerprint of Fructus Schisandrae chinensis extract can provide a scientific evaluation basis for the quality control of scientific evaluation for the quality control of it, and it also provide data support for improving the quality standard of Yiqi Fumai Lyophilized Injection.
[中图分类号]
[基金项目]
天津市中药注射剂关键技术校企协同创新实验室建设(项目编号:17PTSYJC00090)