丹芪偏瘫胶囊质量标准的研究

Studies on quality standard of Danqi Capsule against hemiplegia

关键词:  丹芪偏瘫胶囊  薄层色谱法  质量标准

Key words:  Danqi capsule against hemiplegia  astragaloside IV  Chromatography  thin layer

摘要:

[目的]建立丹芪偏瘫胶囊的质量控制标准。[方法]采用薄层色谱法对丹芪偏瘫胶囊中赤芍、丹参进行定性鉴别,对地鳖虫、全蝎进行显微鉴别,并用薄层扫描法对黄芪中黄芪甲苷进行含量测定。检测波长为530nm;展开剂为氯仿-甲醇-水=13:6:2;显色剂为10%硫酸乙醇溶液。[结果]黄芪甲苷在0.525~10.5μg有良好的线性关系(r=0.9993),平均回收率为96.56%,峰面积(RSD)为1.15%。[结论]该方法简便、专属性强、稳定性好,可作为丹芪偏瘫胶囊的质量控制标准。

Abstract:

[Objective] To establish the standard for the quality control of Qianqi capsule against hemiplegia (DPC).[Methods] Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae were verified by TLC and astragaloside IV was determined by TLCS. The conditions were as follows:the underlayer was CHCL₃-CH₃OH-H₂O(13:6:2) and the sprayer was 10% H₂SO₄-C₂H₅OH. The wave length (λ) used was 530 nm.[Results] The TLC spots were highly specific, clear and concentrated without interference with the presence of negative controls.Concentration curve of astragaloside IV showed a good linearity within the range of 0.525~10.5 μg,r=0.999 3,average recovery rate was 96.56%,and RSD=1.15%.[Conclusion] These methods are simple, rapid and high specific and stable, and can be used as a quantitative methods for the quality control of DPC.