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目的:建立固精麦斯哈胶囊的质量标准。方法:采用气相色谱法对固精麦斯哈胶囊中主要成分丁香酚进行定量分析;对制剂中的主要药味丁香、香附、西红花进行薄层鉴别。结果:用气相色谱法测定丁香酚的含量,在0.211 2～2.112μg丁香酚峰面积值与进样量有良好的线性关系(r=0.999 9),平均加样回收率为99.3%,RSD 0.55%(n=6),薄层图谱斑点清晰,阴性对照无干扰。结论:方法简便,重复性好,可有效控制制剂的质量。
Objective: To establish the quality standard for Gujing Haji Capsule. Methods: Quantitative analysis of eugenol, the main component of the solid-prepared Maxiha capsules, was performed by gas chromatography; thin crusts were identified from the main medicinal flavors of Clove, Cyperus rotundus, and Saffron. RESULTS: The gas chromatography was used to determine the eugenol content. There was a good linear relationship between the eugenol area of 0.211 2 and 2.112 μg and the injection volume (r=0.999 9). The average recovery was 99.3%. RSD 0.55 % (n=6), the spots on the thin layer map are clear, and the negative controls have no interference. Conclusion: The method is simple, reproducible, and can effectively control the quality of the preparation.