加味消毒饮颗粒质量标准研究  

Study on the quality standard for Jiawei Xiaoduyin granules

作　　者：张浩 罗朝亮[2] 韦开听[2] 吴无畏[2] 周贤强 蒋伟哲[1,3] 陈路 Zhang Hao;Luo Chaoliang;Wei Kaixin;Wu Wuwei;Zhou Xianqiang;Jiang Weizhe;Chen Lu(School of Pharmacy,Guangxi Medical University,Nanning 530021,China;Guangxi Zhuang Autonomous Region Medicinal Botanical Garden,Nanning 530023,China;Guangxi Zhuang Yaofang Hospital,Nanning 530150,China)

机构地区：[1]广西医科大学药学院,南宁530021 [2]广西壮族自治区药用植物园,南宁530023 [3]广西壮要方医院,南宁530150

出　　处：《广西医科大学学报》2022年第4期682-686,F0003,共6页Journal of Guangxi Medical University

基　　金：广西壮族自治区南宁市科技计划项目(No.20203109)。

摘　　要：目的:建立加味消毒饮颗粒的质量标准。方法:采用薄层色谱(TLC)法鉴别加味消毒饮颗粒中的黄芩、野菊花和栀子等;采用高效液相色谱法测定加味消毒饮颗粒中黄芩苷的含量,色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),流动相为甲醇∶水∶磷酸(48∶52∶0.1),柱温为30℃,流速为1.0 mL/min,检测波长为330 nm,进样量为10μL。结果:加味消毒饮颗粒供试品色谱分离良好,斑点较清晰,分别在与黄芩素、汉黄芩素、蒙花苷、栀子苷对照品色谱和黄芩、野菊花、栀子对照药材色谱相应的位置上,显相同颜色斑点,其Rf值适中,且阴性对照无干扰;黄芩苷质量浓度线性范围为0.243~1.946μg(r=0.9998),该含量测定方法的精密度、稳定性和重复性均良好;平均回收率为97.30%,RSD为1.78%(n=9);3批加味消毒饮颗粒供试品中黄芩苷的含量在5.0108~5.1282 mg/g范围内。结论:薄层色谱鉴别和含量测定方法可靠、准确、操作简单,可用于加味消毒饮颗粒的质量控制。Objective:To establish the quality standard for Jiawei Xiaoduyin granules.Methods:Thin layer chromatography(TLC)was used to identify Mongolian milkvetch(Huangqi),wild chrysanthemum(Yejuhua)and gardenia(Zhizi)in Jiawei Xiaoduyin Granules.The content of baicalin in Jiawei Xiaoduyin granules was determined by high performance liquid chromatography(HPLC)using a Kromasil C18 column(250 mm×4.6 mm,5μm)with a mobile phase of methanol:water:phosphoric acid at 48:52:0.1,the column temperature was 30℃,the flow rate was 1.0 mL/min,the detection wavelength was 330 nm,and the injection volume was 10μL.Results:Chromatograms of the sample were well separated,and the spots were clear and showed the same color spots at the corresponding positions of baicalin,wogonin,linarin and geniposide control chromatograms and Huangqi,Yejuhua and Zhizi control chromatograms,respectively.The linear range of the mass concentration of baicalin was 0.243 to 1.946μg(r=0.9998),and the precision,stability and reproducibility of the method were good;the average recovery was 97.30%,and the RSD was 1.78%(n=9).The contents of baicalin in the three batches of the samples were in the range of 5.0108-5.1282 mg/g.Conclusion:The method of TLC identification and content determination is reliable,accurate and simple,and can be used for the quality control of Jiawei Xiaoduyin granules.

关 键 词：加味消毒饮颗粒 质量标准 薄层色谱法 黄芩苷 高效液相色谱法 

分 类 号：R282[医药卫生—中药学]