妇科栓剂的质量标准研究  

Study on Quality Standard of Fuke Suppository

作　　者：袁捷[1,2] 李婧[1] 黄松[1,2] 陈吉航[1] 黄孟秋[1] 

机构地区：[1]广州中医药大学,广州510006 [2]东莞广州中医药大学中医药数理工程研究院,广东东莞523808

出　　处：《中国实验方剂学杂志》2010年第14期68-70,共3页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的:研究妇科栓剂的质量标准,以更好控制产品质量。方法:建立黄连、黄柏、苦参、蛇床子的薄层色谱法(TLC)和龙胆苦苷的高效液相色谱含量测定方法。结果:TLC法可检出黄连黄柏、苦参、蛇床子,斑点清晰,阴性对照无干扰专属性强。龙胆苦苷在0.688～6.880μg线性良好(r=0.999 9),平均加样回收率为101.91%,RSD为2.00%(n=6)。结论:试验方法定性、定量方法简单、可靠、准确,可用于该制剂的质量控制。Objective：To study the qualitative standard of Fuke suppository,so as to better control the qual-ity of this product.Method：To establish the thin layer chromatography（TLC） for Rhizoma Coptidis,Cortex Phel-lodendri Chinensis,Radix Sophorae Flavescentis,Fructus Cnidii,and determination method for gentiopicrin by the high performance liquid chromatography（HPLC）.Result：The TLC method could well identify Rhizoma Coptidis,Cortex Phellodendri Chinensis,Radix Sophorae Flavescentis,Fructus Cnidii,with clear spots,non-interference of negative controls and good specificity.Gentiopicrin was linear in the range of 0.688 ～ 6.880 μg,with a good corre-lation coefficient（r = 0.999 9）.The average recovery is 101.91%,RSD as 2.00%（n = 6）.Conclusion：This method is simple,reliable and precise,can be used for qualitative control of this preparation.

关 键 词：妇科栓剂 薄层鉴别 龙胆苦苷 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]