抗柯萨奇B病毒性心肌炎胶囊质量标准

Quality Standard of K-CoxB-JN

摘要:

目的: 建立抗柯萨奇B病毒性心肌炎胶囊(K-CoxB-JN)定性和定量检测方法,为其提供质量控制手段。 方法: 采用薄层色谱法对方中西洋参、麦冬、莱菔子、王不留行4味药物进行定性鉴别;采用HPLC-ELSD法测定西洋参中人参皂苷Rg₁,Re,Rb₁含量。以 Agilent ZORBAX XDB C₁₈(4.6 mm×250 mm, 5 μm)为色谱柱,流动相乙腈-0.2%甲酸(梯度洗脱),柱温为室温;ELSD参数:漂移管温度50℃,载气流速2.0 L·min^-1,增益1。 结果: 薄层色谱专属性强,分离度好,图谱斑点清晰,阴性对照无干扰;人参皂苷Rg₁,Re,Rb₁质量分别在0.75~3.75,4.5~30,6~40 μg对数值与相应峰面积对数值呈良好的线性关系(r>0.999),平均回收率分别为97.10%(RSD 3.96%),95.15%(RSD 2.21%),95.60%(RSD 3.00%)。 结论: 该方法简便、准确、重复性好且无干扰,可用于K-CoxB-JN中主要药材的鉴别以及人参皂苷Rg₁,Re,Rb₁的含量控制。

Abstract:

Objective: To establish quantitative and qualitative determination for the quality control standard of K-CoxB-JN. Method: TLC was used to identify Panacis Quiaquefolii Radix, Ophiopogonis Radix, Raphani Semen and Vaccariae Semen. The content of ginsenoside Rg₁, Re, Rb₁ in K-CoxB-JN was determined by HPLC-ELSD. An Agilent ZORBAX XDB C₁₈ (4.6 mm×250 mm, 5 μm) was used, and the mobile phase consisted of acetonitrile-0.2% formic acid (gradient elution). The temperature was set at room condition. The parameter of evaporative light-scattering detector: the temperature of drift tube was at 50℃ and the nebulizer nitrogen flow rate was 2.0 L·min^-1; gain was 1. Result: The TLC spots were highly clear without the interference of negative sample, and had good separation effect. The linear relationship was obtained within the range of 0.75-3.75, 4.5-30 and 6-40 μg for ginsenoside Rg₁, Re, Rb₁ respectively (r>0.999). The average recoveries of the three components were 97.10% (RSD 3.96%), 95.15% (RSD 2.21%), 95.60% (RSD 3.00%) respectively. Conclusion: The method appeared to be simple, accurate, sensitive and reliable, and can be used in qualitative and quantitative analysis of K-CoxB-JN.