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目的:制备复方麻甘合剂,并建立其质量控制方法。方法:采用水提醇沉的工艺制备复方麻甘合剂;采用薄层色谱法对麻黄、甘草、金银花、紫菀进行定性鉴别,高效液相色谱法测定主药麻黄中盐酸麻黄碱的含量,并进行方法学考察。结果:薄层色谱鉴别斑点明显,无干扰,重复性好;盐酸麻黄碱在0.302～1.260μg范围内与峰面积呈良好的线性关系(r=0.9998,n=5),回收率较好。结论:制备工艺合理,质量稳定;定性、定量方法简便快速,重复性好,可用于该制剂的质量控制。
Objective: To prepare Compound Ganxan Mixture and establish its quality control method. Methods: Compound Ganxan mixture was prepared by water extraction and alcohol precipitation. Qualitative identification of ephedra, licorice, honeysuckle and aster were conducted by TLC. The content of ephedrine hydrochloride in ephedra was determined by HPLC. Methodological study. Results: The TLC spots showed obvious spots with no interference and good reproducibility. Ephedrine hydrochloride had a good linear relationship with the peak area in the range of 0.302-1.260 μg (r = 0.9998, n = 5). The recoveries were good. Conclusion: The preparation process is reasonable and the quality is stable. The qualitative and quantitative methods are simple, rapid and reproducible, and can be used for the quality control of the preparation.