目的 采用高效液相色譜法建立注射用五味子提取物指紋圖譜，并對2015—2016年制備的40批注射用五味子提取物進行指紋圖譜相似度分析。方法 試驗考察了不同流動相組成和濃度、不同檢測波長、不同洗脫方法、不同品牌C₁₈色譜柱（250 mm×4.6 mm，5 μm）、不同流速、不同柱溫等條件下供試品溶液的色譜行為，利用中藥色譜指紋圖譜相似度評價系統(tǒng)對試驗所得色譜圖進行相似度分析。結(jié)果 確定了高效液相色譜檢測條件，建立了20批注射用五味子提取物的對照指紋圖譜（相似度不低于0.991），確定了12個共有峰，并對5個共有峰進行了指認，其余20批供試品與對照圖譜的相似度均值為0.994。結(jié)論 本試驗建立的注射用五味子提取物指紋圖譜可以為其質(zhì)量控制提供科學(xué)的依據(jù)，為完善注射用益氣復(fù)脈（凍干）質(zhì)量標準提供數(shù)據(jù)支持。

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.

天津市中藥注射劑關(guān)鍵技術(shù)校企協(xié)同創(chuàng)新實驗室建設(shè)（項目編號：17PTSYJC00090）