结肠乐灌肠液的质量标准研究

Study on quality standards for Jiechangle Enema

目的建立结肠乐灌肠液的质量标准。方法采用TLC法对结肠乐灌肠液处方中的药材成分黄芩、黄连进行定性鉴别,并用高效液相色谱法(HPLC)对结肠乐灌肠液中的有效成分盐酸小檗碱的含量进行测定。结果结肠乐灌肠液中黄芩、黄连的供试品薄层色谱中,在与对照品色谱相应的位置上,显相同颜色的斑点;盐酸小檗碱含量在10.84~173.40μg/m L,范围内线性关系良好(r=0.999 8),平均回收率97.71%(n=6,RSD=0.55%)。结论该方法简便快捷,结果准确,可作为该制剂的质量控制方法。

Objective To establish the quality standards for Jiechangle Enema.Methods TLC was adopted for qualitative identification of Seutellaria baicalensis and Coptis chinensis in the prescription of Jieehangle Enema, and high performance liquid chromatography （HPLC） was adopted to measure the content of Berberine hydrochloride, which was the effective constituent of Jiechangle Enema. Results The lamina chromatogram of test samples of Scutellaria baicalensis and Coptis chinensis in Jiechangle Enema showed spots with the same color as those corresponding spots in the control chromatogram;the content of Berberine hydrochloride was 10.84- 173.40 p g/mL,with good range linear relation （r = 0.999 8）. The average recovery rate of Berberine hydrochloride was 97.71% （n = 6, RSD = 0.55%）.Conclusion The established method is simple and convenient with accurate results, which can be used effec- tively for the quality control of this preparation.