麻夷鼻炎喷雾剂的质量标准研究

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.

Study on the Quality Standard of Mayi Rhinitis Spray

Objective: To establish quality standards for Mayi Rhinitis Spray. Method: The content of ephedrine hydrochloride and berberine hydrochloride in the Mayi Rhinitis Spray was determined by HPLC, and the qualitative analysis for Herba Ephedrae,Flos Magnoliae, Cortex Phellodendri were performed using TLC. Result: There was good linearity for ephedrine hydrochloride within the range of 7-35 mg·L^-1 (r=0.999 9), and its average recovery was 98.64% with RSD at 1.69% (n=9). There was good linearity for berberine hydrochloride within the range of 1.4-70 mg·L^-1 (r=0.999 7), and its average recovery was 98.30% with RSD at 1.84% (n=6). Herba Ephedrae, Flos Magnoliae, Cortex Phellodendri could be accurately identified by TLC. Conclusion The method is simple, rapid and reproducible, and it can be used for the quality control of Mayi Rhinitis Spray.