消核片质量控制研究

目的: 研究消核片的质量控制。 方法: 采用显微鉴别法对浙贝母和金果榄进行鉴别;采用薄层色谱法对制剂中的夏枯草、半枝莲进行定性鉴别;用高效液相色谱法对浙贝母中贝母素甲和贝母素乙进行了含量测定。色谱柱为Diamonsil C₁₈(200 mm×4.6 mm,5 μm)柱,流动相为乙腈-水-二乙胺(70∶ 30∶ 0.03),流速1.0 mL·min^-1,蒸发光散射检测器。 结果: 显微鉴别可以快速鉴别浙贝母和金果榄;薄层色谱能明显检出夏枯草、半枝莲。贝母素甲在1.7664~5.5200 μg范围内线性关系良好(r=0.9995,n=5),平均回收率98.22%( n=6)。贝母素乙在1.2800~4.0000 μg范围内线性关系良好(r=0.9998 n=5),平均回收率93.45% ( n=6)。 结论: 新建立的质量控制方法能有效地控制消核片的质量,可作为本品质量标准。

Objective: To study on Quality Control of Xiaohe Tablets. Method: Bulbus Fritillariae Thunbergii and radix tinosporae were identified by microscopical identification; Common Selfheal and Sculellaria barbata were determined by TLC;The content of peimine and peiminine were determined by HPLC. Column is Diamonsil C₁₈(200 mm×4.6 mm,5 μm)column and a mixture of methanol-water-diethylaminer(70∶ 30∶ 0.03) as the mobile phase at the flow rate of 1.0 mL·min^-1,ELSD. Result: Bulbus Fritillariae Thunbergii and radix tinosporae were quickly identified by microscopical identification; Prunella vulgaris and Sculellaria barbata were determined by TLC. A linear relationship of Peimine was good from 1.7664-5.5200 μg(r= 0.9995,n=5). The average recovery was 98.22%( n=6). A linear relationship of Peiminine was good from 1.2800–4.0000 μg(r=0.9998, n=5),The average recovery was 93.45% (n=6). Conclusion: The method can be used for the quality control of Xiaohe tablets.