[Objectives]This study was conducted to establish the quality standard for Lujing Yiqi Shengxue Pills to provide a basis for its quality control.[Methods]According to the quality requirements in the 2020 edition of Ch...[Objectives]This study was conducted to establish the quality standard for Lujing Yiqi Shengxue Pills to provide a basis for its quality control.[Methods]According to the quality requirements in the 2020 edition of Chinese Pharmacopoeia,the quality of Lujing Yiqi Shengxue Pills was evaluated from the aspects of properties,identification,inspection and content determination.Radix Astragali,Radix Angelicae Sinensis,Macrocephalae Rhizoma stir-fried with bran and Radix Paeoniae Alba in the preparation were identified and studied by thin layer chromatography(TLC).A high performance liquid chromatography(HPLC)method was established to determine the content of paeoniflorin in the preparation.[Results]The thin layer spots of Radix Astragali,Radix Angelicae Sinensis,Macrocephalae Rhizoma and Radix Paeoniae Alba were clear and round,and the negative preparations had no interference.The properties,moisture,weight difference,loading difference,dissolution time limit and microbial limit all met the requirements.The regression formula for the quantitative analysis of paeoniflorin in the concentration range of 4.86-194.40μg/ml was:Y=12.0241X+0.8797,R^(2)=0.9999;and the average recovery was 98.9%,and the RSD was 1.7%.[Conclusions]The method has good repeatability,and is stable,feasible,simple and convenient in operation and suitable for quality control of Lujing Yiqi Shengxue Pills.展开更多
基金Supported by Guiyang Science and Technology Planning Project(ZKHT[2020]-18-4)。
文摘[Objectives]This study was conducted to establish the quality standard for Lujing Yiqi Shengxue Pills to provide a basis for its quality control.[Methods]According to the quality requirements in the 2020 edition of Chinese Pharmacopoeia,the quality of Lujing Yiqi Shengxue Pills was evaluated from the aspects of properties,identification,inspection and content determination.Radix Astragali,Radix Angelicae Sinensis,Macrocephalae Rhizoma stir-fried with bran and Radix Paeoniae Alba in the preparation were identified and studied by thin layer chromatography(TLC).A high performance liquid chromatography(HPLC)method was established to determine the content of paeoniflorin in the preparation.[Results]The thin layer spots of Radix Astragali,Radix Angelicae Sinensis,Macrocephalae Rhizoma and Radix Paeoniae Alba were clear and round,and the negative preparations had no interference.The properties,moisture,weight difference,loading difference,dissolution time limit and microbial limit all met the requirements.The regression formula for the quantitative analysis of paeoniflorin in the concentration range of 4.86-194.40μg/ml was:Y=12.0241X+0.8797,R^(2)=0.9999;and the average recovery was 98.9%,and the RSD was 1.7%.[Conclusions]The method has good repeatability,and is stable,feasible,simple and convenient in operation and suitable for quality control of Lujing Yiqi Shengxue Pills.
