芪麦降糖丸质量标准研究  

Study on Quality Standard of Qimai Jiangtang Pills

作　　者：余洁真 蔡杏粧 张楠涛 郑璇杏 苏洁 YU Jiezhen;CAI Xingzhuang;ZHANG Nantao;ZHENG Xuanxing;SU Jie(Chaozhou Institute for Drug Control,Chaozhou 521000,China)

机构地区：[1]广东省潮州市药品检验所,广东潮州521000

出　　处：《品牌与标准化》2023年第5期105-107,111,共4页

基　　金：广东省潮州市科技计划项目(2021ZC41)。

摘　　要：目的:提升芪麦降糖丸的质量标准。方法:选用薄层色谱(TLC)法对芪麦降糖丸中的黄芪进行定性鉴别;选用高效液相色谱(HPLC)法对制剂中葛根素及芍药苷的含量进行测定,Agilent ZORBAX SB-C18柱(5μm,4.6 mm×250 mm)为色谱柱,甲醇-0.1%磷酸水溶液(21∶79)为流动相,流速为1.0 m L/min,柱温为40℃,葛根素跟芍药苷各自的检测波长为250 nm跟230nm。结果:黄芪薄层色谱特征斑点明显,与杂质斑点分离好,阴性样品没有干扰。葛根素进样量在0.1583μg~0.5540μg范围内与峰面积呈良好的线性关系(R~2=1.00);芍药苷进样量在0.2064μg~0.7224μg范围内与峰面积呈良好的线性关系(R~2=1.00)。结论:该方法操作简单,能准确地鉴别黄芪,并快速地测定葛根素和芍药苷的含量,能为评价制剂的质量提供参考。Objective:To improve the quality standards of Qimai Jiangtang Pills.Method:Thin layer chromatography(TLC) was used to qualitatively identify Huangqi in Qimai Jiangtang pills;High performance liquid chromatography(HPLC) was used to determine the contents of Puerarin and paeoniflorin in the preparation.Agilent ZORBAX SB-C18 column(5 μm,4.6 mm × 250 mm) as the chromatographic column,methanol 0.1% phosphoric acid aqueous solution(21∶79) as the mobile phase,the flow rate is 1.0 mL/min,the column temperature is 40 ℃,and the detection wavelengths of Puerarin and paeoniflorin are 250 nm and 230 nm respectively.Result:The characteristic spots of Astragalus membranaceus thin layer chromatography are obvious,well separated from impurity spots,and there is no interference in the negative sample.The injection amount of Puerarin is 0.1583 μg~0.5540 μg There is a good linear relationship with peak area within the range of g(R~2=1.00);The injection amount of paeoniflorin is 0.2064 μg~0.7224 μg There is a good linear relationship with peak area within the range of g(R~2=1.00).Conclusion:The method is simple,can accurately identify Astragalus,and quickly determine the contents of Puerarin and paeoniflorin,which can provide a reference for evaluating the quality of preparations.

关 键 词：芪麦降糖丸 薄层色谱法 黄芪 高效液相色谱法 葛根素 芍药苷 

分 类 号：R286.0[医药卫生—中药学]