肤尔康胶囊质量标准提升研究

Study on Quality Control of Fuerkang Capsules

目的:提高肤尔康胶囊的质量标准,保证制剂的安全性和有效性。方法:从定性、定量两方面进行研究,用薄层色谱法(TLC)对肤尔康胶囊中苦参、白芷、牡丹皮三味中药进行定性鉴别;用高效液相色谱法(HPLC)测定肤尔康胶囊中绿原酸的含量。结果:苦参、白芷、牡丹皮的薄层色谱斑点清晰,分离效果较好、无阴性干扰;绿原酸的质量浓度在0~120μg/mL范围内呈良好线性关系(r=0.9994);精密度、稳定性、重复性试验的RSD均≤1.2%;平均加样回收率为98.1%,RSD=1.3%(n=6)。结论:建立的方法有较强的专属性及稳定性,可用于肤尔康胶囊的质量控制。

Objective Improve the quality standard of Fuerkang capsules to ensure the safety and effectiveness of the hospital pharmaceutica.Methods From the qualitative and quantitative analysis,TLC(thin layer chromatography)was used to identify Sophorae Flavescentis Radix,Angelicae Dahuricae Radix and Moutan Cortex in Fuerkang capsules;The content of Chlorogenic acid in Fuerkang capsules was determined by HPLC(high performance liquid chromatography).Results The TLC spots of Sophora Flavescentis Radix,Angelicae Dahuricae Radix and Moutan Cortex peel were clear,with good separation effect and without negative interference;The mass concentration of Chlorogenic acid showed good linear relationship in the range of 0~120μg/mL(r=0.9994);RSDS of precision,stability and reproducibility tests were all lower than 1.2%.The average recovery was 98.1%,RSDS=1.3%(n=6).Conclusion The established method has well specificity and stability,and can be used for the quality control of Fuerkang Capsules.