二十五味珊瑚丸质量标准研究

Study on Quality Standard of 25 Wei Coral Pills

药典2015版,只有红花和西红花的薄层鉴别,以乌头碱计的毒性成分含量限定。由于藏成药方剂大,组成复杂,为控制质量,对所含药材的组织,细胞及其内含物的特征,加以显微鉴别,作为鉴定依据;增加了部分药材的薄层鉴别,君药西红花指标性成分的西红花苷I和Ⅱ的含量测定(西红花苷I在33~330μg,西红花苷Ⅱ在62μg~310μg范围内,有良好的线性关系);从而更好地控制药品质量。结果表明,所建立的质量控制方法可准确地进行定性和定量检测,方法可靠,重复性好,可有效控制二十五味珊瑚丸的质量。

Objective:Pharmacopoeia 2015 edition,only the thin layer of safflower and broccoli identification,limited by the toxic component content of the black caustic soda.Due to the large Tibetan agent and complex composition,for quality control,the I and the content of saffron(which was I in 33-330ug,in 62ug~310ug),and better control the drug quality.Conclusion:The quality control method established in this paper can conduct qualitative and quantitative detection and reliability to control the quality of 25 coral pills.