茜草炭的质量标准提升研究

目的在现行中国药典中茜草炭标准的基础上增加薄层鉴别和含量测定。方法该研究于 2022年 6—8月以 10批茜草和相应的茜草炭为研究对象，鉴别研究采用薄层色谱法，含量测定采用液相色谱法。结果茜草炭薄层色谱中，在与异茜草素对照品色谱相应的位置上，显相同颜色的荧光斑点，可明显区分茜草和茜草炭；含量测定以异茜草素为指标，在 8.2~820.0 mg/L范围内与峰面积呈线性关系( r=0.999 9)，精密度、稳定性和重复性良好( RSD分别为 0.6%、1.8%和 2.4%)，平均加样回收率 99.1%。结论建立的薄层鉴别和含量测定方法简便可行，可为茜草炭的生产及质量控制提供依据。

Improvement of quality standards for carbonized rubiae radix et rhizoma

Objective To add thin-layer identification and content determination to the current carbonized rubiae radix et rhizoma stan? dard in the Chinese Pharmacopoeia.Methods The study was conducted from June to August 2022 with ten batches of rubiae radix et rhi?zoma and its carbon as research subjects. The thin-layer chromatography was used for identification, and high performance liquid chroma? tography for content determination.Results In the thin-layer chromatography, the fluorescence spots of the same color were found in thecorresponding position to the chromatographic reference of xanthopurpurin, which could clearly distinguish the rubiae radix et rhizomaand its carbon. After carbonization, the content of xanthopurpurin was measured in the range of 8.2-820.0 mg/L and the peak area showed a linear relationship(r=0.999 9). The precision, stability and repeatability were good (RSD was 0.6%, 1.8% and 2.4%, respectively), andthe average recovery rate was 99.1%.Conclusion The established methods for thin-layer identification and content determination aresimple and feasible, which can provide reference for the production and quality control of carbonized rubiae radix et rhizoma.