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柴银口服液质量标准研究
引用本文:史国生,谢强胜,李启艳,王玉团. 柴银口服液质量标准研究[J]. 中国药品标准, 2014, 15(5): 343-347
作者姓名:史国生  谢强胜  李启艳  王玉团
作者单位:山东省食品药品检验所,济南250101
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。

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
收稿时间:2014-06-03
修稿时间:2014-09-16

Quality standard for Chaiyin oral solution
Shi Guosheng,Xie Qiangsheng,Li Qiyan and Wang Yutuan. Quality standard for Chaiyin oral solution[J]. , 2014, 15(5): 343-347
Authors:Shi Guosheng  Xie Qiangsheng  Li Qiyan  Wang Yutuan
Affiliation:(Shandong Institute for Food and Drug Control, Jinan 250101 )
Abstract: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.
Keywords:Chaiyin Mixture  TLC  HPLC  saikosaponin a  saikosaponin d
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