重参消炎胶囊质量标准研究

Study On Quality Standard For Chongshen Xiaoyan Capsule

目的:建立重参消炎胶囊的质量标准。方法:采用薄层色谱法对重参消炎胶囊中的重楼、当归、苦参进行定性鉴别;采用高效液相色谱法测定制剂中苦参碱的含量,色谱柱:NUCLEOSIL-NH2(4.6 mm×250 mm,5μm)柱;流动相:乙腈-无水乙醇-3%磷酸溶液(80∶10∶10);流速:1.0 mL/min;柱温:25℃;检测波长为220 nm。结果:重楼、当归、苦参特征斑点清晰,分离度好,阴性无干扰。苦参碱在0.433 2~2.166 0μg范围内呈良好的线性关系,r=0.999 45,平均回收率为100.54%,RSD=1.85%。结论:所建立的方法简便准确,专属性、重复性好,可作为重参消炎胶囊的质量控制标准。

Objective：To establish the quality standard for chongshen xiaoyan capsule.Methods：Rhizoma Paridis,Radix Angelicae Sinensis and Radix Sophorae Flavescentis were identified by TLC;The content of matrine was determined by HPLC in this preparation.NUCLEOSIL-NH_2 column was used.The mobile phase was consisted of Acetonitrile-Ethanol-water wich 3% phosphoric acid（80∶10∶10）.The flow rate was 1.0 mL·min^（-1） and column temperature was at 25 ℃.The detection wave length was at 220 nm.Results：The spots on TLC plates were clear without indeference in the blank reference.The linear range of matrine was（0.433 2）～（2.166 0 μg）,r=（0.999 45.）The average recovery of matrine was 100.54% and RSD was 1.85%.Conclusion：The methods of identification and quantification is easy,accurate and reproducible.It can be used effectively for the quality control of this preparation.