生脉饮(党参方)中五味子醇甲含量的测定方法

Determination method of Schisandrin content in Shengmaiyin(Dangshen Famula)

目的建立生脉饮(党参方)中五味子醇甲含量的测定方法。方法采用高效液相色谱法(HPLC)测定生脉饮(党参方)中五味子醇甲含量。色谱条件:色谱柱为Agilent色谱柱(4.6 mm×250 mm,5μm),流动相为甲醇-水(62:38),检测波长为250 nm,流速为1.0 ml/min,进样体积为10μl。结果五味子醇甲的进样量在0.02084～0.41680 mg/ml范围内,与其峰面积呈良好的线性关系,回归方程Y=2×10~7X(r=1,n=5);精密度良好(RSD=0.23%)、稳定性良好(RSD=0.4%)、重复性试验的RSD为0.87%。平均加样回收率为102.9%,RSD为0.7%(n=6)。颈复康药业集团有限公司生产的3批生脉饮(党参方)中五味子醇甲的平均含量分别为1.827、1.736和1.703 mg/支,平均RSD为0.1%。结论所建立的方法准确、灵敏、简便,可用于生脉饮(党参方)中五味子醇甲的含量测定。

Objective To establelish a determination method of Schisandrin content in Shengmaiyin (Dangshen Famula). Methods High performance liquid chromatography (HPLC) was used to deternmine Schisandrin content in Shengmaiyin (Dangshen Famula). The chromatographic condition: Agilent column (4.6 mm×250 mm, 5 μm) was used, the mobilephase consisted of methyl alcohol-water, the detection wavelength was at 250 nm, the flow ratew was 1.0 ml/min, the volume was 10 μl. Results The linear range of Schisandrin was 0.02084~0.41680 mg/ml, it had a good linear relationship with its peak area, the regression equation was Y=2×10^7X (r=1, n=5). The accuracy was good (RSD=0.23%), the stability was good (RSD=0.4%), and the RSD of the repeated test was 0.87%. The average recovery was 102.9% and the RSD was 0.7%(n=6). The average contents of three batches of Schisandrin in Shengmaiyin (Dangshen Famula) produced by Jingfukang Pharmaceutical Group Co., Ltd. were 0.182 mg, 0.173 mg and 0.165 mg in each Shengmaiyin (Dangshen Famula). The average RSD was 0.1%. Conclusion This method is accurate, sensive, simple and stability, and has good reproducibility. It is suitable for the determination of Schisandrin in Shengmaiyin (Dangshen Famula).