鼻窦饮合剂质控标准的研究

Study on Quality Standard of Bidouyin Mixture

目的建立鼻窦饮合剂的质控标准。方法采用薄层色谱法鉴别鼻窦饮合剂中的麻黄、厚朴;采用高效液相色谱法定量检测鼻窦饮合剂中的阿魏酸含量。结果麻黄、厚朴的薄层色谱鉴别效果好、专属性强,分离度高,且阴性样品无干扰;阿魏酸在0.0336~1.6800μg范围内与峰面积呈良好的线性关系（r=1）;平均加样回收率为：101.79%,RSD为：0.47%。结论本文建立的方法不仅操作简便、结果准确、重现性好,而且能够对鼻窦饮合剂进行定性和定量质量控制,符合中成药的质控要求。

OBJECTIVE To establish the quality control standard for Bidouyin mixture. METHODS The TLC method was used to identify of ephedrae herba and magnoliae officinalis cortex in Bidouyin mixture,the content of Ferulic acid was determined quantitatively by HPLC. RESULTS The TLC identification of ephedrae herba and magnoliae officinalis cortex was fairly exclusive,specialty,well-seperated without interference from negative control,the linear range of ferulic acid was in 0. 0336 ~ 1. 6800μg range（ r = 1）; the average recovery rate was 101. 79%,RSD： 0. 47%. CONCLUSION The established qualitative and quantitative method is simple,accurate,well reproducible and can be used for the quality control of Bidouyin Mixture.