益气强心胶囊的质量标准研究  

Quality Standard of Yiqi Qiangxin Capsules

作　　者：聂继红[1] 王萍[1] 刘兆龙[1] 

机构地区：[1]新疆医科大学附属中医医院,乌鲁木齐830000

出　　处：《中国药房》2014年第7期644-646,共3页China Pharmacy

摘　　要：目的：建立益气强心胶囊的质量标准。方法：采用薄层色谱（TLC）法对益气强心胶囊中的黄芪、红景天、丹参、葶苈子进行定性鉴别；采用高效液相色谱法测定制剂中丹酚酸B的含量：色谱柱为VP-ODS柱（150mm×4．6mm，5μm），流动相为甲醇-乙腈-2％甲酸溶液（24：9：67，V/V/V），检测波长为286nm，柱温为35℃，流速为1ml／min。结果：黄芪、红景天、丹参、葶苈子的TLC斑点清晰、分离度好，且阴性对照无干扰。丹酚酸B的质量浓度在0．0278～0．1390mg／ml范围内与其峰面积积分值呈良好的线性关系（r=O．9999）；精密度、稳定性、重复性试验的RSD〈2％；平均加样回收率为100．29％，RSD=1．91％（n=6）。结论：所建标准可用于益气强心胶囊的质量控制。OBJECTIVE： To establish the quality standard of Yiqi qiangxin capsule. METHODS： TLC was used to identify Astragali Radix, Rhodiola crenulata, Salvia miltiorrhiza and Lepidium apetalum in Yiqi qiangxin capsule qualitatively; the content of salvianolic acid B was determined by HPLC. The separation was performed on VP-ODS （150 mm×4.6 mm, 5 μm） column with methanol-acetonitrile-2 % methanoic acid （24：9：67, V/V/V）as mobile phase at the flow rate of 1 ml/min. The detection wavelength was set at 286 nm, and column temperature was 35 ℃. RESULTS： TLC spots of them were clear and well-separated without interference from negative control. The linear range of salvianolic acid B were 0.027 8-0.139 0 mg/ml （r=0.999 9） ; RSDs of precision, stability and reproducibility tests were lower than 2% ; average recovery was 100.29% （RSD= 1.91%, n=6）. CONCLUSIONS： The standard can be used for quality control of Yiqi qiangxin capsules.

关 键 词：益气强心胶囊 质量标准 薄层色谱法 高效液相色谱法 黄芪 红景天 丹参 葶苈子 丹酚酸B 

分 类 号：R283.65[医药卫生—中药学] R917[医药卫生—中医学]