复方苦参注射液的质量标准研究

目的 :建立复方苦参注射液的质量控制标准。方法 :用薄层色谱法对该制剂中当归、苦参进行定性鉴别 ;用 HPL C法测定该制剂中阿魏酸的含量 ,并用 TLC法测定该制剂中苦参碱的含量。结果 :薄层色谱中斑点清晰 ,易于识别 ;阿魏酸在 1.95～ 9.76μg·mg-1范围内呈线性关系 ,r=0 .9980 ,平均回收率为 96.8 ,RSD=0 .3。苦参碱斑点在 2 .16～ 7.5 6μg之间与其吸收度积分值呈线性关系 ,r=0 .9992 ,平均回收率为99.0 ,RSD=0 .61。结论 :本法可有效地控制复方苦参注射液的质量

Study on Quality Standards for Compound Injection of Radix sophorae flavescentis

OBJECTIVE:To establish a quality control standard of compound Radix sopharae flavescentis injecton.METHODS:The Radix angelicae sinensis and Radix sophorae flavescentis in compound Radix sophrae flvescentis injection were identified by TLC.The content of ferulic acid in the injection was determined by HPLC.Also the content of matrine in the injection was determined by TLC-scanning.RESULTS:The spots in the TLC were clear and distinguishable.The linear ranges of ferulic acid was 1.95-9.76 μg.ml -1] ,r=0.9980.The average recovery was 96.8%,RSD=0.3%.The linear ranges of matrine was 2.16-7.56 μg,r=0.9992(n=6).The average recovery was 99.0%,RSD=0.61%.CONCLUSIONS:These methods can be used for quality control of compound Radix sophrae flavescentis injection.