复方链呋油滴鼻剂的制备与质量控制

Preparation and Quality Control of Compound Lianfuyou Nasal Drops

目的:制备复方链呋油滴鼻剂并建立其质量控制方法。方法:以甘油、吐温-80等为辅料,以呋喃西林、盐酸麻黄碱为主药制备复方链呋油滴鼻剂;采用高效液相色谱法测定制剂中2种主药的含量。结果:所制制剂性状及鉴别等均符合2005年版《中国药典》规定;呋喃西林及盐酸麻黄碱的检测浓度线性范围分别为3.9～19.5、200.2～1001.0μg.mL-1;平均回收率分别为99.76%、100.03%,RSD分别为1.40%、0.88%。结论:该制剂性质稳定,质量控制方法简单易行、快速准确。

OBJECTIVE： To prepare compound Lianfuyou nasal drops and establish a quality control method for this preparation. METHODS： Compound Lianfuyou nasal drops were prepared with excipients such as glycerol and tween - 80 and with nitrofurazone and ephedrine hydrochloride as main compositions; and the contents of nitrofurazone and ephedrine hydrochloride were determined by HPLC. RESULTS： The property and identification of the preparation met the criteria recommended by Chinese Pharmacopoeia （2005 edition） . The linear range was 3.9--19.5 μg · mL^- 1 for nitrofurazone vs. 200.2- 1 001.0μg· mL^- 1 for ephedrine hydroehloride, with mean recovery rates of 99.76% and 100.03% and RSD of 1.40% and 0.88%, respectively. CONCLUSION： The compound Lianfuyou nasal drops is stable in quality, and the quality control method is simple, feasible, rapid and accurate.