目的 建立參仙升脈口服液的特征指紋圖譜及多指標成分定量測定方法。方法 采用Ultimate LP-C₁₈(250 mm×4.6mm,5μm)色譜柱,以乙腈和0.2%磷酸水溶液為流動相梯度洗脫,檢測波長為270nm(0~16min,24~38min)、210 nm(16~24 min,38~100min),體積流量為1.0mL·min^-1,柱溫為30°C,進樣量為10μL。應用中藥色譜指紋圖譜相似度評價軟件(2012版)對10批參仙升脈口服液進行分析,建立HPLC指紋圖譜,并測定10個指標成分的含量。結果 建立的指紋圖譜確定共有峰28個,指認了其中12個,10批樣品間相似度均在0.934以上。定量分析的10個成分分別為丹參素、鹽酸偽麻黃堿、補骨脂苷、異補骨脂苷、迷迭香酸、丹酚酸B、補骨脂素、異補骨脂素、朝藿定C和淫羊藿苷,質量濃度分別為1.218~2.781、 0.333~0.702、 2.391~4.120、 2.083~3.486、 0.151~0.203、 0.158~1.046、 0.189~0.286、0.196~0.305、0.231~0.403和0.323~0.512 mg·mL^-1。結論 所建立的指紋圖譜與多指標成分定量方法準確可靠,可用于參仙升脈口服液較全面的質量控制。

Objective To establish the characteristic fingerprint of Shenxian-Shengmai Oral Liquid and the quantitative method of multi-index components.Methods The Ultimate LP-C₁₈(250 mm×4.6 mm, 5 μm) column was used with acetonitrile and 0.2%phosphoric acid aqueous solution as mobile phase gradient elution. The flow rate was 1.0 mL·min^-1. The column temperature was 30 ℃, and the detection wavelength was 270 nm(0—16 min, 24—38 min) and 210 nm(16—24 min, 38—100 min). Ten batches of Shenxian-Shengmai Oral Liquid were analyzed by using traditional Chinese medicine chromatographic fingerprint similarity evaluation software(2012 edition), HPLC fingerprints were established, and the contents of 10 index components were determined.Results A total of 28 common peaks were calibrated, of which 12 common peaks were identified, and the similarity of the fingerprints between 10 batches of samples was above 0.934. The 10 components of quantitative analysis were danshensu,pseudoephedrine hydrochloride, psoralenoside, isopsoralenoside, rosmarinic acid, salvianolic acid B, psoralen, isopsoralen, epmedin C, icariin, respectively. The contents were 1.218—2.781 mg·mL^-1, 0.333—0.702 mg·mL^-1, 2.391—4.120 mg·mL^-1, 2.083 —3.486 mg·mL^-1, 0.151—0.203 mg·mL^-1, 0.158—1.046 mg·mL^-1, 0.189—0.286 mg·mL^-1, 0.196—0.305 mg·mL^-1, 0.231 —0.403 mg·mL-1 and 0.323—0.512 mg·mL-1, respectively.Conclusion The established fingerprint and multi-index component quantitative method are accurate and reliable, and can be used for comprehensive quality control of Shenxian-Shengmai Oral Liquid.

R284.1

陜西省重點研發(fā)計劃項目(2021ZDLSF04-06,2022ZDXM-SF-06); 陜西省“秦藥”研發(fā)重點實驗室項目(2021-QYPT-001); 秦創(chuàng)園中醫(yī)藥創(chuàng)新研發(fā)轉化項目(2022-QCYZH-006); 陜西省中醫(yī)藥管理局“秦藥”開發(fā)重點科學研究項目(2021-02-ZZ-019); 陜西中醫(yī)藥大學中醫(yī)體質與疾病防治省級重點實驗室開放課題(KF2210)