黄藤素的质量控制及稳定性研究

Quality control and stability study of Fibriuretinin

目的:制定产品含量、有关物质的检测方法;通过稳定性研究确定贮存条件和产品有效期。方法:采用高效液相色谱法检测产品中盐酸巴马汀及有关物质的含量;采用半制备液相色谱法从黄藤素母液中分离提纯,得到纯度高达99%的盐酸药根碱;采用原子吸收分光光度法测定产品中的金属离子Ba2+的残留量。结论:制定了专属性强、重现性好、准确度高的检测方法;确定产品的贮存条件和产品有效期。

Objective:Formulate detection methods for product content and related substances;Determine storage conditions and product shelf life through stability study;Methods:Determination of palmatine hydrochloride and organic impurities in the product by HPLC;By semi preparative liquid chromatography,jatrorrhizine hydrochloride with a purity of 99%;Determination of residual metal ion Ba2+in the product by atomic absorption spectrophotometry was obtained from the mother solution of synthetic berberine.Conclusion:developed a highly exclusive,reproducible and accurate detection method;Determine the storage conditions and shelf life of products.