[1]刘 升,王延珍,冯文丽,等.扶正解毒口服液质量控制方法研究[J].医学信息,2019,(07):100-103.[doi:10.3969/j.issn.1006-1959.2019.07.029]
 LIU Sheng,WANG Yan-zhen,FENG Wen-li,et al.Study on Quality Control Method of Fuzheng Jiedu Oral Liquid[J].Medical Information,2019,(07):100-103.[doi:10.3969/j.issn.1006-1959.2019.07.029]
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扶正解毒口服液质量控制方法研究()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
期数:
2019年07期
页码:
100-103
栏目:
论著
出版日期:
2019-04-01

文章信息/Info

Title:
Study on Quality Control Method of Fuzheng Jiedu Oral Liquid
文章编号:
1006-1959(2019)07-0100-04
作者:
刘 升1王延珍2冯文丽1吕凤霞1
(1.河南牧翔动物药业有限公司,河南 郑州 451162;2.河南众科博奕生物科技有限公司,河南 焦作 454950)
Author(s):
LIU Sheng1WANG Yan-zhen2FENG Wen-li1LV Feng-xia1
(1.Henan Muxiang Animal Pharmaceutical Co.,Ltd.,Zhengzhou 451162,Henan,China;2.Henan Zhongke Boyi Biotechnology Co.,Ltd.,Jiaozuo 454950,Henan,China)
关键词:
扶正解毒口服液薄层鉴别含量测定
Keywords:
Fuzheng Jiedu oral liquidThin layer identificationContent determination
分类号:
R286.0
DOI:
10.3969/j.issn.1006-1959.2019.07.029
文献标志码:
A
摘要:
目的 建立扶正解毒口服液的质量控制方法。方法 采用TLC法对扶正解毒口服液中的板蓝根、黄芪和淫羊藿进行鉴别;采用HPLC法测定(R,S)-告依春的含量。结果 在薄层色谱鉴别中均能检出板蓝根、黄芪和淫羊藿的特征性斑点;以(R,S)-告依春对照品浓度为横坐标,峰面积为纵坐标,以峰面积(Y,μv)对浓度(X,μg/ml)进行线性回归,绘制标准曲线,其回归方程为:Y=45784.94X-17640.25,相关系数r=0.99997,试验结果表明:(R,S)-告依春浓度在4.63~123.38 μg/ml,呈良好的线性关系。标准中建立的(R,S)-告依春的含量测定方法耐受性良好、灵敏度高、重现性好、专属性强,可以有效控制产品的质量。结论本方法能准确、可靠的对扶正解毒口服液中(R,S)-告依春含量进行测定,可作为该制剂的质量控制方法。
Abstract:
Objective To establish a quality control method for Fuzheng Jiedu Oral Liquid. Methods TLC method was used to identify Radix Isatidis, Astragalus and Epimedium in Fuzheng Jiedu Oral Liquid. The content of (R, S)-Gu Yichun was determined by HPLC. Results The characteristic spots of Radix Isatidis, Astragalus and Epimedium were detected in the identification of TLC; the concentration of (R, S)-Guyuechun reference was taken as the abscissa, the peak area was the ordinate, and the peak area was(Y, μv) linear regression of concentration (X, μg / ml), draw a standard curve, the regression equation is: Y=45784.94X-17640.25, correlation coefficient r=0.99997, the test results show:(R, S) - The concentration of spring was in the range of 4.63~123.38 μg/ml, showing a good linear relationship. The method for determining the content of (R, S)-Yueyichun established in the standard is well tolerated, sensitive, reproducible and specific, which can effectively control the quality of the product.Conclusion The TLC method can accurately and reliably determine the content of (R,S)-Gu Yichun in Fuzheng Jiedu Oral Liquid, which can be used as the quality control method of the preparation.

参考文献/References:


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更新日期/Last Update: 2019-04-01