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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(200mm×4.6 mm,5μm)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1.7664～5.5200μg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1.2800～4.0000μg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 the quality control of ablation tablets. Methods: Microspore identification method was used to identify Fritillaria cirrhosa and Camellia oleifera. The contents of Prunella vulgaris and Scutellaria barbata were identified by TLC, the contents of Fritillary A and carbomer B were determined. The column was Diamonsil C18 (200 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-water-diethylamine (70:30:0.03) and the flow rate was 1.0 mL · min-1. The light scattering detector was evaporated. Results: Micro-identification can quickly identify Fritillaria cirrhosa and gold fruit; thin-layer chromatography can detect Prunella vulgaris, Scutellaria barbata. The linear relationship was found between 1.7664 and 5.5200 μg (r = 0.9995, n = 5) and the average recovery was 98.22% (n = 6). The linear relationship was found between 1.2800 and 4.0000 μg (r = 0.9998 n = 5) and the average recovery was 93.45% (n = 6). Conclusion: The newly established quality control method can effectively control the quality of the tablet and can be used as the quality standard of this product.