参附益肾胶囊的质量标准研究  

Study on Quality Standard of Shenfu Yishen Capsule

作　　者：盛春帅[1] 周鹃[1] 李海霖[1] 

机构地区：[1]青海省中医院,西宁810000

出　　处：《中国药房》2016年第33期4735-4738,共4页China Pharmacy

摘　　要：目的：建立参附益肾胶囊的质量标准。方法：检测制剂中手参的显微特征;采用薄层色谱法（TLC）对制剂中丹参、大黄、甘草、红景天、肉桂进行定性鉴别;采用高效液相色谱法测定制剂中黄芪甲苷的含量：色谱柱为Phenomenex Luna-C18,流动相为乙腈-水（35∶65,V/V）,流速为1.0 ml/min,柱温为30℃。结果：制剂中手参显微特征显著。丹参、大黄、甘草、红景天、肉桂TLC图斑点清晰,分离度好。黄芪甲苷检测进样量线性范围为0.832 8-4.164 0μg（r=0.999 9）;精密度、稳定性、重复性试验的RSD≤2.03%;加样回收率为95.02%-104.33%（RSD=3.80%,n=6）。结论：该研究所建标准可用于参附益肾胶囊的质量控制。OBJECTIVE： To establish the quality standard for Shenfu yishen capsule. METHODS： The microscopic characteris- tics of Gymnadenia conopsea were detected; TLC was adopted for the qualitative identification of Salvia miltiorrhiza, Rheum pal- matum, Glycyrrhiza uralensis, Rhodiola rosea and Cortex cinnamomi; HPLC was used for the content determination of astragalo- side： the column was Phenomenex Luna-C18 with mobile phase of acetonitrile-water （35：65, V/V） at a flow rate of 1.0 ml/min, col- umn temerpature was 30 ℃. RESULTS： Microscopic identification features of G. conopsea were exclusive, TLC identification of S. miltiorrhiza, R. palmatum, G. uralensis, R. rosea and C. cinnamomi was well separated and specific; the linear range of astraga- loside was 0.832 8-4.164 0 μg （r=0.999 9） ;RSDs of precision, stability and reproducibility tests were no higher than 2.03% ;recovery was 95.02%-104.33% （RSD=3.80% ,n=6）. CONCLUSIONS： The standard can effectively control the quality of Shenfu yishen capsule.

关 键 词：参附益肾胶囊 质量标准 薄层色谱法 高效液相色谱法 黄芪甲苷 

分 类 号：R284.1[医药卫生—中药学]