南板蓝根质量标准研究

Study of Quality Standard on Roots of Baphicacanthus cusia

对12批南板蓝根药材和6批南板蓝根饮片进行定性定量实验研究,以提高南板蓝根的质量标准.采用显微法和TLC法对南板蓝根进行定性鉴别研究,HPLC法测定靛玉红的含量,色谱柱：Kromasil-C18（200×4.6 mm,5μm）,流动相：乙腈-0.1%磷酸溶液（55∶45）;检测波长为289 nm.结果表明：显微法特征明显,TLC法斑点清晰,专属性强,可与板蓝根区别;靛玉红的定量测定在0.0102~0.612μg/m L呈良好的线性关系,r=0.99996,平均回收率为99.13%,RSD小于3.0%.本方法简单灵敏,准确可靠,重现性好,可完善现行的质量标准,对保证其质量和临床疗效具有重要意义.

To develope the quality standard of Baphicacanthus cusia （Nees）Bremek,a qualitative and quantita-tive experiment of 12 batches of B.cusia herbs and 6 batches decotion pieces is carried out.The qualitative identi-fication of B.cusia is studied by microscopy and TLC methods.The content of Indirubin in herbs and decoction pieces are determined by HPLC.The results are as follows：chromatographic column being Kromasil-C18 （200 × 4.6 mm,5μm）;mobile phase being Acetonitrile-0.1% phosphoric acid （55：45 ）;detection wavelength being 289nm.The results indicate that microscopy method has obvious characteristics.The clear spots of TLC,which are highly specific,could be distinguished from Radix Isatidis.Quantitative determination of Indirubin between 0.0102~0.612 μg/mL show good linear relationship with r=0.99996,the average recovery rate being 99.13%and RS-Ds less than 3.0%.The proposed method is simple,sensitive,accurate,reliable with good reproducibility,so that it could improve the existing quality standard,by ensuring quality and clinical efficacy of B.cusia.