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目的:建立麻夷鼻炎喷雾剂的质量标准。方法:高效液相色谱法对处方中君药麻黄中盐酸麻黄碱和臣药黄柏中盐酸小檗碱的含量进行定量分析,薄层色谱法对麻黄、辛夷、黄柏进行定性鉴别。结果:盐酸麻黄碱含量在7～35 mg.L-1(r=0.999 9),呈良好的线性关系,平均回收率为98.64%,RSD 1.69%(n=9);盐酸小檗碱含量在1.4～70 mg.L-1(r=0.999 7),呈良好的线性关系,平均回收率为98.30%,RSD 1.84%(n=6);采用的薄层色谱法专属强。结论:建立的方法可准确地进行定性、定量检测,重复性好,可作为麻夷鼻炎喷雾剂的质量控制。
OBJECTIVE: To establish the quality standard of hay rhinitis spray. Methods: The contents of ephedrine hydrochloride and berberine hydrochloride in the prescriptions of Rhizoma Phytocrypha were determined by HPLC. The contents of berberine hydrochloride in the prescriptions of Rhizoma Chuanxiong, Magnolia biondii and Phellodendron chinense were identified qualitatively by TLC. Results: The content of ephedrine hydrochloride in the range of 7-35 mg.L-1 (r = 0.999 9) showed a good linear relationship with an average recovery of 98.64% and RSD 1.69% (n = 9). The content of berberine hydrochloride was 1.4 ~ 70 mg.L-1 (r = 0.999 7). The average recovery was 98.30% with RSD 1.84% (n = 6). Conclusion: The established method can accurately qualitative and quantitative detection, good reproducibility, and can be used as quality control of Rhinitis rhinitis spray.