栀子厚朴汤胶囊剂质量标准研究

Study on quality standard of Zhizi Houpu decoction capsule

为建立栀子厚朴汤胶囊剂质量控制标准,采用薄层色谱法(TLC)对栀子厚朴汤胶囊剂中的栀子、厚朴和枳实三味药材进行定性鉴别;采取高效液相法(HPLC),对君药栀子中的有效成分栀子苷建立了含量测定的方法.结果表明,栀子、厚朴、枳实三味药材的薄层色谱主斑点清晰,分离良好;栀子苷在0.31~1.53μg(r=0.9999)线性良好,平均加样回收率为98.23%.建立的TLC和HPLC方法可靠、专属性强、准确、重现性好,可全面控制栀子厚朴汤胶囊剂的质量.

To establish the quality control standard of gardenia grandpa capsule,the method of thin layer chromatography（ TLC） was used to qualitatively identify gardenia,magnolia officinalis and citrus aurantium. The HPLC method was used to establish a method for determination of geniposide in gardenia jasminoides. The results showed that the main spots of gardenia,magnolia officinalis and citrus aurantium were clear and well separated. The linearity of geniposide was 0. 40 - 2. 0 μg（ r = 0. 999 9）,and the average recoveries were 98. 23%.The established TLC and HPLC method was reliable,specific,accurate,reproducible and could control the quality of gardenia grandpa capsules.