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目的:建立浓缩型咽炎颗粒(无糖型)的质量标准。方法:采用薄层色谱(TLC)法对方中玄参、北豆根、甘草进行定性鉴别;采用高效液相色谱法测定本制剂的有效成分蒙花苷的含量。结果:TLC斑点清晰、分离度高。蒙花苷进样量在4.64～69.6μg范围内与峰面积积分值呈良好线性关系(r=0.9999);平均加样回收率为98.65%,RSD=0.79%(n=6)。结论:所建标准可用于浓缩型咽炎颗粒(无糖型)的质量控制。
Objective: To establish a quality standard for concentrated pharyngitis granules (sugar-free type). Methods: TLC, TLC, HPLC method was used to qualitatively identify Radix Scrophulariae, Radix et Rhizoma Rhei and Radix Glycyrrhizae. HPLC was used to determine the content of Radix Angelica Sinensis in this preparation. Results: TLC spots clear, high resolution. There was a good linear relationship between the amount of monatin and the peak area integral value in the range of 4.64-69.6μg (r = 0.9999). The average recoveries were 98.65% and RSD = 0.79% (n = 6). Conclusion: The proposed standard can be used for quality control of concentrated pharyngitis granules (sugar-free type).