复方银杏叶胶囊质量标准的研究  

Study on the Quality Control Standards of “Compound Yinxingye Capsule”

作　　者：沈洁[1] 任世禾[1] 

机构地区：[1]上海市中医医院药剂科,上海200071

出　　处：《上海中医药杂志》2007年第6期79-81,共3页Shanghai Journal of Traditional Chinese Medicine

摘　　要：目的研究复方银杏叶胶囊的质量控制方法。方法采用TLC法对复方中的银杏叶提取物、白芍药、人参叶分别进行薄层鉴别研究。采用HPLC方法,样品用甲醇超声提取30min,在C18柱上以甲醇-水(31:69)为流动相,在波长230nm处紫外检测测定复方中芍药苷的含量。结果银杏叶提取物、白芍药和人参叶薄层鉴别具有较好的专属性,芍药苷含量测定的线性范围为0.120～1.80μg,线性回归方程为Y=2100.48X+8.65968,r=0.9999,平均回收率为100.41%,RSD为3.02%。测定了复方白芍药中芍药苷的含量。结论本质量标准可有效地控制复方银杏叶胶囊的药物质量。Objective To establish the quality control standards of the ＂Compound Yinxingye Capsule＂. Method Folium Ginkgo Extract, Radix Paeoniae Alba, and Folium Ginseng were identified by TLC. The contents of Paeoniflofin in the Capsules were determined by I-IPLC method with an ultrasonic bath for 30 min in sample preparation, a column of C18 as stationary phase, methanol-water （31：69） as mobile phase and UV detector at 230 nm, Result The TLC identification methods of 3 materials had good specificities. Paeoniflorin has a good linearity in range of 0.120-1.80 μg, Y=2100.48X＋8.65968,r=0.9999, and the average recovery is 100.41% with tLSD=3.02% （n=5）. Conclusion The quantity and quality methods can contol the quality of ＂Compound Yinxingye Capsule＂.

关 键 词：复方银杏叶胶囊 质量标准 芍药苷 薄层色谱法 高效液相色谱法 

分 类 号：R286[医药卫生—中药学]