不同厂家产黄芪注射液中黄芪甲苷的含量考察

Determination of astragaloside Ⅳ in Radix Astragali Injection

目的 :以黄芪甲苷为含量测定指标 ,考察不同生产厂家生产的黄芪注射液的质量。方法 :建立HPLC ELSD测定黄芪甲苷的方法 ,对黄芪注射液中的黄芪甲苷进行含量测定。HypersilODS2 C18(2 5 0mm× 4 .6mm ,5 μm)色谱柱 ,柱温 :4 0℃ ,流动相 :乙腈 水 (36∶6 4 ) ,流速 :1.0mL·min-1,ELSD检测器漂移管温度 :10 0℃ ,气体 (空气 )流速 :3.0L·min-1。结果 :黄芪甲苷在 2 .4～ 12 μg呈良好的线性关系 ,相关系数为r=0 .9997,加样回收率为 10 1.6 % ,RSD为 2 .9% ,n =5。测定了 5个厂家生产的 10批黄芪注射液 ,结果样品间的黄芪甲苷含量的差异较大。结论 :用HPLC ELSD测定黄芪注射液中黄芪甲苷含量的方法快速简便 ,灵敏度高 ,结果可靠 ,重现性较好 ,可作为黄芪注射液质量评价的依据。目前 ,商品黄芪注射液中黄芪甲苷含量差异较大 。

AIM: To examine the quality of Radix Astragali Injection from different manufacturers. METHODS: The HPLC-ELSD method for the determination of astragaloside Ⅳ in Radix Astragali Injection was established with hypersil ODS 2 C 18 column(250mm×4.6mm,5μm), column temperature at 40℃. The mobile phase was acetonitrile-water (36∶64) and flow rate was at 1.0mL·min -1. The evaporation light-scattering detector was used with its drift tube temperature at 100℃ and the gas flow rate: 3.0L·min -1. RESULTS: Within 2.4～12μg astragaioside Ⅳ had a good linearity. The average recovery was 101.6%, RSD=2.9%,n=5. By analyzing the samples of 10 batch of Radix Astragali Injection from 5 manufactuers, it showed there were significant difference in the contents of astragaloside Ⅳ. CONCLUSION: The method is simple and fast. The results are accurate and reproducible and can be used in the quality control of Radix Astragali Injection. The significant differences in the astragaloside content may influence clinical treatmem.