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目的:制备除湿止汗散,并建立其质量控制方法。方法:采用干燥、粉碎的工艺制备除湿止汗散;采用薄层色谱法对苦参、蛇床子、薄荷脑、冰片进行定性鉴别,高效液相色谱法同时测定君药苦参和蛇床子中苦参碱和蛇床子素的含量。结果:薄层色谱鉴别斑点明显,无干扰,重复性好;苦参碱和蛇床子素分别在0.77~15.4μg,0.15~3.0μg范围内与峰面积呈良好的线性关系(r=0.999 8和r=0.999 6),平均回收率分别为98.46%(RSD=0.69%),99.03%(RSD=0.96%)。结论:制备工艺合理,质量稳定;定性、定量方法简便快速,可用于该制剂的质量控制。
Objective: To prepare dehumidification and antiperspirant powder and to establish its quality control method. METHODS: The dehumidifier and antiperspirant powder were prepared by the process of drying and pulverization. The TLC, HPLC and HPLC were used for the qualitative identification of Sophora flavescens, Cnidium, Menthol and Borneolum, respectively. Ginseng and osthole content. Results: The TLC spots showed obvious spots with no interference and good reproducibility. Matrine and osthole were linear with peak area in the range of 0.77 ~ 15.4μg and 0.15 ~ 3.0μg respectively (r = 0.999 8 and r = 0.999 6). The average recoveries were 98.46% (RSD = 0.69%) and 99.03% (RSD = 0.96%), respectively. Conclusion: The preparation process is reasonable and the quality is stable. The qualitative and quantitative methods are simple and rapid and can be used for the quality control of the preparation.