妇科十味片质量标准探讨  

Study on the Quality Specification of Fuke Shiwei Tablets

作　　者：魏春芬 陈金泉 巴小翠 王玲华 

机构地区：[1]山东省东营市药品检验所,257091

出　　处：《中国药事》2005年第4期235-237,共3页Chinese Pharmaceutical Affairs

摘　　要：探讨妇科十味片的质量标准。采用HPLC法对妇科十味片中的芍药苷进行含量测定。以SHIMADZUVP -ODSC18为色谱柱,乙腈-水-冰醋酸(14∶85 2∶0 8)为流动相,检测波长为2 30nm ;芍药苷的线性范围为0 1～1μg (r=0 9999) ,平均加样回收率为98 8% ,RSD为1 5 % ;同时对制剂中的君药香附、当归进行了薄层鉴别,薄层色谱斑点清晰,无干扰,易分辨。方法可靠,重现性好,可用于该制剂的质量控制。A HPLC method for the determination of paeoniflorin in Fuke Shiwei tablets was established. A Shimadzu VP-ODS C_~18 column was used with CH_3CN-H_2O-ICE HACHAc(14∶85.2∶0.8) as mobile phase. The flow rate was 1.0ml·min^-1 , column temperature 40℃ and the detection wave length 230nm. The average recovery was 98.8%, RSD 1.5%. Rhizoma cyperi and Radix angelicae sinesis in the tablets were identified by TLC. The chromatographic spots were clear, without interference and easy to recognize. The method is accurate and highly reproducible. It could be used for the quality control of Fuke Shiwei tablets.

关 键 词：妇科十味片 质量标准 芍药苷 HPLC 

分 类 号：R926.23[医药卫生—药学]