盐炙黄芪的质量标准

Quality standard for Astragali Radix Praeparata Cum Melle by salt

目的建立盐炙黄芪质量标准。方法分别采用显微鉴别、薄层色谱法对盐炙黄芪进行鉴别,按2020年版《中国药典》通则方法测定水分、浸出物和总灰分的含量,HPLC法测定黄芪甲苷和毛蕊异黄酮葡萄糖苷含量。结果药材显微特征明显,薄层色谱法鉴别斑点清晰,专属性良好。水分、浸出物和总灰分的平均含量分别为4.5%、35.3%和4.0%。黄芪甲苷在1.08~10.8μg范围内线性关系良好(R^(2)=0.9994),平均回收率为96.2%,盐炙黄芪中黄芪甲苷含量不得少于0.050%。毛蕊异黄酮葡萄糖苷在10.6~212.0μg/mL范围内线性关系良好(R^(2)=0.9996),平均回收率为96.0%,盐炙黄芪中毛蕊异黄酮葡萄糖苷不得少于0.020%。结论本研究制订了盐炙黄芪的质量标准,可用于盐炙黄芪的质量控制和相关产品的检验。

Objective To establish the quality standard of Astragali Radix Praeparata Cum Melle by salt.Methods The methods of microscopic identification and thin layer chromatography(TLC)were used to identify Astragali Radix Praeparata Cum Melle by salt.The contents of moisture,extract,and total ash were detected according to Chinese Pharmacopoeia(2020 Edition).The contents of Astragaloside IV and calycosin-7-O-β-D-glucoside were determined by high performance liquid chromatography.Results The microscopic characteristics was apparent,and the spots of TLC were distinct.The average content of moisture,extract,and total ash were 4.5,35.3%and 4.0%,respectively.The linearity of Astragaloside IV(1.08-10.8μg)and calycosin-7-O-β-D-glucoside(10.6-212.0μg/mL)was good(R^(2)=0.9994,and R^(2)=0.9996,respectively).The average recovery of Astragaloside IV and calycosin-7-O-β-D-glucoside was 96.2%and 96.0%,respectively.The content of Astragaloside IV and calycosin-7-O-β-D-glucoside should not be less than 0.050%and 0.020,respectively.Conclusion This study established a complete standard of Astragali Radix Praeparata Cum Melle by salt,which could be applied to the quality control of Astragali Radix Praeparata Cum Melle by salt and the test of related product.