化痔灵片的制备与质量标准研究

Study on The Preparation and Quality Control of Fargelin Tablets

目的:制备化痔灵片并建立其质量控制方法。方法:以黄连、五倍子、三七、槐花等为主要成分制备化痔灵片。采用薄层色谱法对处方中主要药材与有效成分黄连和盐酸小檗碱、五倍子和没食子酸、槐花和芦丁、三七和人参二醇、猪胆汁膏和猪去氧胆酸分别进行定性鉴别,并进行砷盐的限量检查。采用高效液相色谱法(HPLC)测定化痔灵片中盐酸小檗碱的含量。结果:薄层色谱鉴别斑点清晰、明显,无干扰,重复性好。含砷量不得超过万分之十。化痔灵片中盐酸小檗碱的含量每片不得少于50μg。结论:该制剂制备工艺简便,定性、定量等质量控制方法准确简易。

OBJECTIVE：To prepare Fargelin Tablets and establish method for its quality control. METHODS： Fargelin Tablets were prepared with Coptis Chinensis, Galla Chinensis, Panax Notoginseng and Flos Sophorae as main components. The chief drugs and active components including Coptis Chinensis and berberine, Gallnut Chinensis and gallic acid,Flos Sophorae and rutoside, Panax notoginseng and panaxadiol, Pig Gall Paste and hyodeoxycholic acid in Huazhiling Tablets were identified by thin layer chromatography （TLC）. The limit of arsenic salt was detected as well. The content of berberine hydrochloride in Huazhiling Tablets was determined by HPLC. RESULTS： The TLC spots were clear and obvious and free of interference with good reproducibility. The content of arsenic must be kept at no more than 0. 1%. The content of berberine hydrochloride in each tablet should be kept at no less than 50μg. CONCLUSION： The preparation technology is simple, and the qualitative and quantitative methods for quality control of the preparation are simple and accurate.