建立杞黄醒脑颗粒的质量标准,为其质量控制提供依据.采用薄层色谱法(TLC)对杞黄醒脑颗粒中枸杞子、淫羊藿、丹参、仙茅、当归、何首乌进行鉴别,采用高效液相色谱法(HPLC)测定制剂中二苯乙烯苷的含量.色谱柱 Waters Bridge C18柱(4.6×250 mm, 5 μL),流动相为甲醇-水(体积比36∶64),检测波长 320 nm,流速 1.0 mL/min,柱温 30 ℃.结果表明枸杞子、淫羊藿、丹参、仙茅、当归、何首乌的TLC图谱主斑点清晰,分离度好,阴性对照无干扰;二苯乙烯苷在0.195 6~2.934 0 μg(R2=0.999 5,n=6)内线性关系良好,精密度、重复性、稳定性的RSD均小于2.0%,加样回收率为96.38%~100.19%,RSD为1.48%.该质量标准项目设置合理,操作便捷、准确,可用于杞黄醒脑颗粒的质量控制.
The quality standard of Qihuang Xingnao Granule is established to provide reference for its quality control. Thin layer chromatography(TLC)was used to identify Barbary wolfberry, Epimedium, Salvia miltiorrhiza, Rhizoma curculiginis, Angelica sinensis and Polygonum multiflorum in the granules. The content of diphenylvinyl glycosides in the preparation was determined by high performance liquid chromatography(HPLC). The HPLC conditions were: Waters Bridge C18 column(4.6× 250 nm, 5 μL), methanol-water(36∶64), detection wavelength of 320 nm, flow rate of 1.0 mL/min, and a column temperature of 30 ℃. The main TLC spots of Barbary wolfberry, Epimedium, Salvia miltiorrhiza, Rhizoma curculiginis, Angelica sinensis and Polygonum multiflorum were clear, the separation was good, and the negative control had no interference. The stilbenside was linearly related in the range of 0.195 6 to 2.934 0 μg(R2=0.999 5, n=6), the RSD of precision, repeatability and stability was less than 2.0%, the sample recovery rate ranged from 96.38% to 100.19%, and the RSD was 1.48%. The quality standard project is set reasonably, convenient and accurate, and can be used for the quality control of Qihuang Xingnao Granules.
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