麻附甘胶囊质量标准研究

Study on Quality Standard of Mafugan Capsule

目的:建立麻附甘胶囊的质量标准,为其质量控制提供方法。方法:采用薄层色谱法鉴别麻附甘胶囊中附子、蜜麻黄、炙甘草;采用HPLC法对制剂中麻黄碱与伪麻黄碱进行含量测定。结果:薄层鉴别斑点清晰,专属性强。盐酸麻黄碱在0.0596~1.192μg范围内线性关系良好,平均回收率为97.36%,RSD为1.89%(n=6);盐酸伪麻黄碱在0.0312~0.624μg范围内线性关系良好,平均回收率为97.94%,RSD为1.12%(n=6)。结论:建立的方法准确、简便,可有效的控制麻附甘胶囊的质量。

Objective：To establish the quality standard of Mafugan Capsule,provide methods of quality control. Methods：Aconiti Lateralis Praeparata Radix,Ephedrae,Radix Glycyrrhizae Preparata Rhizoma were identified by TLC;ephedrine and pseudoephedrine were determined by HPLC. Results：The chromatographic spots were clear and well-specificity. The linear range of ephedrine hydrochloride was 0.0596-1.192 μg,the average recovery was 97.36%,RSD was 1.89%（n=6）;the linear range of pseudoephedrine hydrochloride was 0.0312-0.624 μg,the average recovery was 97.94%,RSD was 1.12%（n=6）. Conclusion：The method was accurate and sample,could be used to control the quality of Mafugan Capsule effectively.