柴银口服液质量标准研究  

Study on the Quality Standard of Chaiyin Mixture

作　　者：史国生[1] 谢强胜[1] 李启艳[1] 王玉团[1] 

机构地区：[1]山东省食品药品检验所,济南250101

出　　处：《中国药品标准》2014年第5期343-347,共5页Drug Standards of China

摘　　要：目的：修订完善柴银口服液质量标准。方法：用薄层鉴别主药苦杏仁；用高效液相色谱法测定柴胡皂苷a和柴胡皂苷d的含量。结果：苦杏仁薄层鉴别方法具有专属性；柴胡皂苷a和柴胡皂苷d分别在0.068～1.70μg（r＝0.9999）和0.058～1.45μg（r＝0.9998）范围内线性关系良好，平均回收率分别为99.7％（RSD为0.75％）、96.5％（RSD为1.40％）。结论：所建立的方法合理可行，重复性好，可用于柴银口服液的质量控制。Objective：To improve the methods of identification and assay of Chaiyin Mixture.Methods：Armeniacae Semen Amarum was identified by TLC and the contents of saikosaponin a and saikosaponin d were determined by HPLC.Results：The TLC spots of Armeniacae semen Amarum were fairly clear.The linear ranges of saikosaponin a and saikosaponin d were 0.068-1.70μg（ r=0.9999） and 0.058-1.45 μg（r=0.9998）, the average recoveries were 99.7%（RSD=0.75%） and 96.5%（RSD=1.40%） respectively.Conclusion：The results indicated that the methods were reasonable, feasible and highly reproducible, which could be used for the quality control of Chaiyin Mixture.

关 键 词：柴银口服液 薄层色谱 高效液相色谱法 柴胡皂苷A 柴胡皂苷D 

分 类 号：R921.2[医药卫生—药学]