同仁牛黄清心片质量标准的研究

Quality standard for TongRenNiuHuangQingXin Tablet

目的:研究同仁牛黄清心片中人工牛黄、人参的鉴别和芍药苷含量测定的方法。方法:采用薄层层析方法鉴别主要药物,用反相高效液相色谱法测定制剂中芍药苷的含量,以甲醇-0.05mol/L磷酸二氢钾(25 75)为流动相,Symmetry ShieldTM Rp18(3.9mm×150mm,5μm)为固定相,流速为0.8ml/min,检测波长为230nm,柱温为30℃。结果:确立了制剂中人工牛黄和人参的鉴别方法。芍药苷在0.10-0.51μg范围内呈现良好的线性关系,回归方程为Y=1605260X-17363,r=0.9999。平均回收率为98.94%,RSD为2.05%。结论:该实验建立的鉴别和含量测定方法具有专属性强、准确、重复性好的特点,可用于同仁牛黄清心片的质量控制。

Objective： To study the method of identification and content determination of the important component in TongRenNiuHuangQingXin Tablet. Method：The major compounds in this drug were identified by the thin layer chromatographic method and the contents of paeoniflorin were determined by HPLC. The HPLC procedure was used in the determination： the chromatographic column was Symmetry Shield^TM Rp18 （ 3.9mm×150mm, 5μm ） , the mobile phase was methanol - 0.05mol/L potassium dihydrogen phosphate （25：75） with a flow velocity of 0.8ml/min, the detection wave length was 230nm, and the room temperature was 30℃. Results： Calculus Bovis Artifactus and Gensing were identified. The regression equation of paeoniflorin was in the range of 0.10-0.51μg. The average recovery of the procedure was 98.94%（RSD=2.05%）. Conclusion： The identification and determination methods established were specific and repeatable, which can be used to control the quality of TongRenNiuHuangQingXin Tablet.