复方妇炎消胶囊质量标准提高研究  

Improvement of the Quality Standard for Compound Fuyanxiao Capsule(复方妇炎消胶囊)

作　　者：马善波 李怡心 曹金一 李龙 杨倩[3] 缪珊 杨志福 石小鹏 文爱东 MA Shan-bo;LI Yi-xin;CAO Jin-yi;LI Long;YANG Qian;MIAO Shan;YANG Zhi-fu;SHI Xiao-peng;WEN Ai-dong(Xijing Hospital,Air Force Medical University,Xi'an Shaanxi 710032,China;China Pharmaceutical University,Nanjing Jiangsu 210009,China;Shaanxi University of Traditional Chinese Medicine,Xianyang Shaanxi 712046,China)

机构地区：[1]空军军医大学西京医院,陕西西安710032 [2]中国药科大学,江苏南京210009 [3]陕西中医药大学,陕西咸阳712046

出　　处：《中医药导报》2020年第6期31-34,共4页Guiding Journal of Traditional Chinese Medicine and Pharmacy

基　　金：陕西省医疗机构中药制剂规程的建立与实施(2019-zz-zc001)。

摘　　要：目的:建立复方妇炎消胶囊的质量提高标准。方法:采用薄层色谱法对当归、赤芍、红花进行定性鉴别;采用高效液相色谱法定量测定赤芍中芍药苷的含量,色谱柱:Welch XB-C18色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈-0.1%磷酸溶液(14∶86);检测波长:230 nm;流速:1.0 mL/min;进样量:20μL;柱温:30℃。结果:薄层鉴别斑点清晰,在与对照品相同的位置上显相同颜色的荧光斑点,阴性样品无干扰;芍药苷含量在0.482,4~2.412,0μg之间线性良好(r=0.999,9),平均回收率为99.08%,RSD为1.56%(n=6)。结论:本方法结果可靠,操作简便,可作为复方妇炎消胶囊的质量控制方法。Objective:To improve the quality standard for compound fuyanxiao capsule.Methods:The three herbs in the preparation,Danggui(Angelica sinensis),Chishao(Radix Paeoniae Rubra),Honghua(Carthamus tinctorius),were identified by TLC qualitatively.The content of Paeoniflorin in Chishao(Radix Paeoniae Rubra)was determined by HPLC.The chromatographic separation was carried out on a Welch XB-C18(250 mm×4.6 mm,5μm),column at 30℃.The mobile phase consisted of acetonitrile-0.1%phosphoric acid(14∶86)with gradient elution at a flow rate of 1.0 mL/·min,and the injection volume was 20μL.The detection wavelength was 230 nm.Results:The spots in TLC were clear without any interference.The linear range of Paeoniflorin was0.482,4-2.412,0μg(r=0.999,9).The average recovery was 99.08%and the RSD was 1.56%(n=6).Conclusion:The method is reliable and easy to operate,which can be used as the quality control method for Compound Fuyanxiao Capsule.

关 键 词：复方妇炎消胶囊 质量标准 高效液相色谱法 薄层色谱法 

分 类 号：R284.1[医药卫生—中药学]