麻杏止咳糖浆质量标准研究

Research on the quality standard of Maxingzhike Syrup

目的优化麻杏止咳糖浆的质量标准。方法在原标准基础上,增加了法半夏的TLC鉴别,建立了HPLC法测定盐酸麻黄碱及马兜铃酸A的含量。结果法半夏TLC鉴别斑点清晰、分离度好,阴性样品无干扰;含量测定盐酸麻黄碱对照品质量浓度在10.024~75.180μg·mL^(-1)范围内线性关系良好(r=0.999 8);平均加样回收率为98.6%,RSD值为1.0%。马兜铃酸A的质量浓度在0.040~1.000μg·mL^(-1)范围内具有良好的线性关系(r=0.999 9);平均加样回收率为97.8%,RSD值为1.3%。结论所用定性、定量方法准确可靠,能有效控制麻杏止咳糖浆的质量标准。

Objective To optimize the quality standard of Maxingzhike Syrup prescription.Methods On the basis of original quality standard,a TLC method of Rhizoma pinelliae praeparata were added and different HPLC methods for the determination of ephedrine hydrochloride were established.Results TLC spots were clear and well separated without any interference.The linear range of ephedrine hydrochloride was 10.024-75.180μg·mL^-1（r=0.999 8）and aristolochic acid A was 0.040-1.000μg·mL^-1（r=0.999 9）.The average recovery of ephedrine hydrochloride was 98.6%（RSD=1.0%）and aristolochic acid A was 97.8%（RSD=1.3%）.Conclusion The method is accurate,reliable and can effectively control the quality of Maxingzhike Syrup.