白驳丸质量标准提升研究  

Study on improvement of quality standard of Baibo Pills

作　　者：陈占功[1] 赵小伟[1] 吴剑坤[1] 白燕 CHENG Zhangong;ZHAO Xiaowei;WU Jiankun;BAI Yan(Department of Pharmacy,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China)

机构地区：[1]首都医科大学附属北京中医医院药学部,北京100010

出　　处：《中国医药导报》2021年第24期11-16,F0003,共7页China Medical Herald

基　　金：全国中药特色技术传承人才培训项目(国中医药办人教函〔2014〕141号)。

摘　　要：目的完善白驳丸质量标准,为其质量标准提升提供科学依据。方法采用显微鉴别法鉴别蒺藜、防风、鸡血藤、红花、黑豆;采用薄层色谱法(TLC)定性鉴别当归、首乌藤、赤芍;采用AgilentSB-C_(18)十八烷基硅烷键合硅胶柱(250 mm×4.6 mm,5μm),梯度洗脱,柱温40℃,流速为1.0 ml/min,流动相采用甲醇-水(55∶45),检测波长为246 nm,测定白驳丸中异补骨脂素、补骨脂素含量。结果蒺藜、防风、鸡血藤、红花、黑豆显微特征明显;当归、首乌藤、赤芍TLC斑点清晰,阴性对照无干扰;补骨脂素在0.0204~0.3066μg范围呈良好的线性关系(r=0.9999),平均回收率为98.08%,相对标准偏差(RSD)=1.07%;异补骨脂素在0.0204~0.3054μg范围呈良好的线性关系(r=0.9998),平均回收率为97.92%,RSD=1.99%。结论本方法全面、准确、重复性好,提升了白驳丸的质量控制水平。Objective To improve the quality standard of Baibo Pills and to provide scientific basis for improving its quality standard.Methods Microscopical identification method was used to identify puncturevine caltrop fruit,divaricate saposhnikovia root,suberect spatholobus stem,safflower and heidou.Thin layer chromatography(TLC)was used to identify chinese angelica,tuber fleeceflower stem and peony root.The AgilentSB-C_(18) octaneylsilane bonded silica gel column(250 mm×4.6 mm,5μm)was used with gradient elution.The column temperature was 40℃,the flow rate was 1.0 ml/min,and the mobile phase was methanol-water(55∶45).The detection wavelength was 246 nm.The content of isopsoralen and psoralen in Baibo Pills was determined.Results The microscopic characteristics of puncturevine caltrop fruit,divaricate saposhnikovia root,suberect spatholobus stem,safflower and heidou were obvious.TLC spots of chinese angelica,tuber fleeceflower stem and peony root were clear,and negative control had no interference.The linear range of psoralen was 0.0204-0.3066μg(r=0.9999).The average recovery was 98.08%,relative standard deviation(RSD)=1.07%;The linear range of isopsoralen was 0.0204-0.3054μg(r=0.9998).The average recovery was 97.92%,RSD=1.99%.Conclusion The method is comprehensive,accurate and reproducible,which can improve the quality control of Baiba Pills.

关 键 词：白驳丸 显微鉴别法 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R286[医药卫生—中药学]