摘要
目的建立扶正润肠丸的质量标准。方法参照《中华人民共和国药典》2015年版通则规定及相关文献,采用薄层色谱(TLC)法对扶正润肠丸中黄芪、肉苁蓉、熟地黄等3味中药进行定性鉴别;采用高效液相色谱(HPLC)法测定扶正润肠丸中指标性成分松果菊苷、毛蕊异黄酮葡萄糖苷、毛蕊花糖苷的含量。结果TLC定性鉴别方法能够有效鉴别3味药材,薄层斑点清晰,且阴性对照无干扰;松果菊苷、毛蕊异黄酮葡萄糖苷、毛蕊花糖苷的回归方程分别为Y=1.246×10^8X-1.730×10^4(r=0.9995)、Y=6.998×10^8X+5.119×10^3(r=0.9996)、Y=2.948×10^8X-1.687×10^4(r=0.9996),线性范围分别为1.1×10^-3~7.7×10^-2,2.950×10^-5~2.065×10^-3,1.33×10^-4~9.31×10^-3mg/m L;平均加样回收率分别为101.04%,99.80%,100.32%,RSD分别为1.16%,1.47%,1.19%;20批样品含量测定结果中松果菊苷、毛蕊异黄酮葡萄糖苷、毛蕊花糖苷含量范围分别为22.710~38.226,0.363~0.597,2.970~6.012 mg/g。结论建立的质量控制方法专属性强、简便、快捷,可用于扶正润肠丸的质量控制。
Objective To establish the quality standard of Fuzheng Runchang Wan(扶正润肠丸).Methods In reference to the general principle of Chinese Pharmacopoeia(2015 edition)and related documents,thin-layer chromatography(TLC)method was established for the qualitative identification of three ingredients of Chinese materia medica including Radix Astragali,Herba Cistanches,and Rhizoma Rehmanniae Preparata in Fuzheng Runchang Wan.The high performance liquid chromatography(HPLC)method was established for content determination of the index components echinacoside,calycosin-7-glucoside,and verbascoside.Results TLC qualitative identification method can effectively identify 3 ingredients of medicinal materials,with clear thin layer spot,negative control without interference.The regression equation of echinacoside,calycosin-7-glucoside and verbascoside was Y=1.246×10^8 X-1.730×10^4(r=0.9995),Y=6.998×10^8 X+5.119×10^3(r=0.9996)and Y=2.948×10^8 X-1.687×104(r=0.9996),respectively.The linear range was 1.1×10^-3-7.7×10^-2,2.95×10^-5-2.065×10^-3and 1.33×10^-4-9.31×10^-3 mg/mL,respectively.The average recovery rate was 101.04%,99.80%and 100.32%,respectively.RSD was 1.16%,1.47%and 1.19%,respectively.The content determination of 20 batches of samples shows that the content of echinacoside,calycosin-7-glucoside and verbascoside was 22.710 to 38.226,0.363 to 0.597 and 2.970 to6.012 mg/g,respectively.Conclusion The established quality control method is specific,simple and fast,and can be used for quality control of Fuzheng Runchang Wan.
作者
孙岚萍
马转霞
马天翔
顾志荣
祁梅
许爱霞
葛斌
SUN Lanping;MA Zhuanxia;MA Tianxiang;GU Zhirong;QI Mei;XU Aixia;GE Bin(School of Pharmacy,Gansu University of Chinese Medicine,Lanzhou,Gansu,730101,China;Department of Pharmacy,Gansu Provincial the People's Hospital,Lanzhou,Gansu,730000,China)
出处
《甘肃中医药大学学报》
2020年第3期29-34,共6页
Journal of Gansu University of Chinese Medicine
基金
甘肃省人民医院研发攻关项目(18GSSY2-3)。
关键词
扶正润肠丸
薄层色谱
高效液相色谱
松果菊苷
毛蕊异黄酮葡萄糖苷
毛蕊花糖苷
质量标准
Fuzheng Runchang Wan(扶正润肠丸)
thin-layer chromatography(TLC)
high performance liquid chromatography(HPLC)
echinacoside
calycosin-7-glucoside
verbascoside
quality standard
