消脂平片的质量控制研究

Quality Control of Xiaozhipin Tablet

目的:研究并完善消脂平片的质量标准。方法:采用薄层色谱法鉴别了消脂平片中的黄芪、丹参和大黄,采用高效液相色谱-蒸发光散色法对消脂平片中的黄芪甲苷进行含量测定,色谱柱为Lichrospher-C_(18)(4.6mm×250 mm,5μm);流动相为乙腈-水(32∶68),1 mL·min^(-1)等度洗脱;漂移管温度75℃;气体压力25 psi。结果:薄层色谱分离度好,斑点清晰;黄芪甲苷的进样量在0.471 336~4.242 024μg(r^2=0.999 3)范围内与峰面积呈良好的线性关系,平均加样回收率为102.44%(n=5),RSD为2.45%。结论:该方法简便、可靠,可作为该制剂的质量控制方法。

Objective： To research and improve the quality standard of Xiaozhipin Tablet for better controlling the quality of drugs. Method： The TLC was employed on Astragalus,Salvia and rhubarb for identification. Use the HPLC-ELSD to determine the content of Astragaloside in Xiaozhipin Tablet. A Lichrospher-C18 column（ 4. 6 mm × 150 mm,5μm）was used. The mobile phase was methanol-water（ 32 ∶ 68）. The flow rate was 1 mL· min^-1. An eweaporative light-scattering detector（ ELSD） model 2424 was used with the drift tube temperature at 75 ℃ and the gas pressure was 25 psi. Results： The TLC chromatographic spots were clear and had a good separation. The linear range of astragaloside was 0. 471 336 ~ 4. 242 024 μg（ r^2= 0. 999 3）. The average recovery was 102. 44%（ n = 5） and RSD was 2. 45%. Conclusion： The method is simple and reliable and it can be used to control the quality of Xiaozhipin Tablet.