摘要
目的建立参芪益气口服液的质量标准。方法采用薄层色谱(TLC)法对黄芪、党参、当归、山银花进行定性鉴别;采用高效液相色谱(HPLC)波长切换法测定方中主要药效成分毛蕊异黄酮葡萄糖苷、阿魏酸、绿原酸的含量,色谱柱为AgilentHC-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(1∶999,V/V),梯度洗脱(0~10 min时10%A,10~60 min时10%A~18%A),流速为1.0 mL/min,检测波长为绿原酸、毛蕊异黄酮葡萄糖苷260 nm(0~25 min,45~60 min),阿魏酸315 nm(25~45 min),柱温为30℃,进样量为20μL,检测时间为60 min。结果TLC斑点显色清晰,分离度好,阴性对照无干扰。绿原酸、阿魏酸、毛蕊异黄酮葡萄糖苷的进样量分别在70.40~704.00μg,1.36~13.60μg,1.28~12.80μg范围内与峰面积线性关系良好;平均加样回收率分别为99.44%,101.04%,97.97%,RSD分别为2.54%,1.57%,2.09%(n=6);精密度、重复性、稳定性试验结果的RSD均小于2%(n=6)。结论该方法操作简便,结果准确,稳定性和重复性均较好,可用于控制参芪益气口服液的质量。
Objective To establish the quality standard of Shenqi Yiqi Oral Liquid.Methods Astragali Radix,Codonopsis Radix,Angelicae Sinensis Radix and Lonicerae Flos were qualitatively identified by the thin-layer chromatography(TLC)method.The contents of calycosin-7-glucoside,ferulic acid and chlorogenic acid were determined by the high-performance liquid chromatography(HPLC)wavelength switching method.The chromatographic column was Agilent HC-C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(1∶999,V/V)with gradient elution(10%A at 0-10 min,10%A-18%A at 10-60 min),the flow rate was 1.0 mL/min,the detection wavelength was 260 nm(0-25 min,45-60 min)for chlorogenic acid and calycosin-7-glucoside,315 nm(25-45 min)for ferulic acid,the column temperature was 30℃,the injection volume was 20μL,and the detection time was 60 min.Results TLC spots showed clear color and good resolution,and the negative samples had no interference.The linear ranges of chlorogenic acid,ferulic acid and calycosin-7-glucoside were 70.40-704.00μg,1.36-13.60μg and 1.28-12.80μg,respectively.The average recoveries of chlorogenic acid,ferulic acid and calycosin-7-glucoside were 99.44%,101.04%,97.97%with RSDs of 2.54%,1.57%,2.09%(n=6),respectively.The RSDs of precision,repeatability and stability tests were less than 2%(n=6).Conclusion The method is simple,accurate,stable and reproducible,which can be used for the quality control of Shenqi Yiqi Oral Liquid.
作者
李萍
曾金
欧人豪
韦祖巧
肖萍
LI Ping;ZENG Jin;OU Renhao;WEI Zuqiao;XIAO Ping(Liuzhou Maternity and Child Healthcare Hospital·Liuzhou Institute of Reproduction and Genetics·Affiliated Maternity Hospital and Affiliated Children's Hospital of Guangxi University of Science and Technology,Liuzhou,Guangxi,China 545001)
出处
《中国药业》
CAS
2022年第1期80-84,共5页
China Pharmaceuticals
基金
广西壮族自治区中医药局自筹经费科研课题[GZZC2019188]。
