doi:10.16597/j.cnki.issn.1002-154x.2022.03.001
海藻配方颗粒的指纹图谱与含量测定研究
李国鹏 周永康 闫晓鑫 韩君∗
(北京康仁堂药业有限公司 中药配方颗粒关键技术国家地方联合工程研究中心,北京 101301)
Study on Fingerprint and Content Determination of Seaweed Formula Granules
Li Guopeng; Zhou Yongkang; Yan Xiaoxin; Han Jun∗;
(National and Local Joint Engineering Research Center for Key Technology of Chinese Medicinal Composition Granules, Beijing Tcmages Pharmaceutical Co. , Ltd. , Beijing 101301)
摘要:
目的:对海藻配方颗粒的指纹图谱与含量测定研究。方法:采用Shim-pack GISTC18-AQ(250mm×4.6mm,5μm)色谱柱;以有机相乙腈和水相0.08%磷酸溶液为流动相进行梯度洗脱。结果:15批海藻配方颗粒的指纹图谱中确定了7个共有峰且相似度大于0.90,含量测定:尿苷在1.5μg/mL~37.4μg/mL范围内的回归方程为y=30521867.57x+560.98, R2=0.9999,平均回收率为95.9%(n=9),RSD为0.83%,两者重复性、精密度、稳定性方法学均符合规定。结论:该方法建立可为海藻配方颗粒的质量评价提供参考。
关键词：海藻配方颗粒；指纹图谱；尿苷；含量；
Abstract：
Objects: Study the fingerprint and content determination of seaweed formula granules. Method: Gradient elution was performed with Shim-pack GIST C18-AQ (250 mm×4.6 mm, 5μm) chromatographic column and acetonitrile organic phase and 0.08% phosphoric acid aqueous solution as mobile phase. Results: The fingerprints of 15 batches of seaweed formula granules identified 7 common peaks with similarity greater than 0.90;determination of content: the regression equation of uridine in the range of 1.5μg/mL~37.4μg/mL was y = 30521867.57x + 560.98,R2 = 0.9999, the average recovery was 95.9% (n = 9) and RSD was 0.83%. The two are both in line with the regulations in respect of repeatability, precision, stability and methodology. Conclusion: The builted method can provide reference for the quality evaluation of seaweed formula granules.
Keywords：seaweed formula granules; fingerprint; uridine; content;