复方呋喃西林滴鼻液质量标准提高研究  

Improving Quality Standards of Compound Nitrofurazone Nasal Drops

作　　者：金丽[1] 周建丽[1] 张晓丹[1] 伍小勇[1] 卜莹[1] 古卓良[1] 

机构地区：[1]南京军区联勤部药品仪器检验所,江苏南京210002

出　　处：《解放军药学学报》2015年第1期61-64,共4页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：军队医疗机构制剂标准提高科研专项课题;No.13ZJZ07

摘　　要：目的提高并完善复方呋喃西林滴鼻液（呋麻滴鼻液）的质量标准。方法利用麻黄碱和呋喃西林在乙醚中不同的溶解性改进盐酸麻黄碱的化学鉴别方法;采用HPLC法同时测定呋麻滴鼻液中的盐酸麻黄碱和呋喃西林,选择PurospherSTAR RP-C18（4.6 mm×150 mm,5μm）色谱柱,以磷酸盐缓冲液（p H 3.0±0.1）-乙腈（85∶15）为流动相,流速为1.0ml·min^-1,检测波长257 nm。结果采用改进后的化学鉴别方法对3批样品中的盐酸麻黄碱进行鉴别,均呈正反应;盐酸麻黄碱和呋喃西林分别在400.25~2401.49、8.47~50.83μg·ml^-1浓度范围内线性关系良好,r=0.9997;平均回收率分别为99.4%和98.1%。结论提高后的质量标准具有专属性强、准确度高、重复性好的特点,可用于该制剂的质量控制。Objective To improve the quality standards of compound nitrofurazone nasal drops. Methods The method for chemical identification of ephedrine hydrochloride was optimized by different solubility of ephedrine and nitrofurazone in ether. HPLC was performed on a column of Purospher STAR RP-C18（ 4. 6 mm × 150 mm,5μm） at the detection wavelength of 257 nm and the flow rate of 1. 0 ml·min^- 1. Results Chemical identification of ephedrine hydrochloride in three samples using the optimized method resulted in a positive reaction. A good linear relationship was established between the peak response and the concentration of ephedrine hydrochloride and nitrofurazone over the range of 400. 25- 2401. 49 μg·ml^-1（ r = 0. 9997） and 8. 47- 50. 83 μg·ml^-1（ r = 0. 9997）respectively. The mean recovery of ephedrine hydrochloride and nitrofurazone was 99. 4%,98. 1% and 101. 07%,respectively. Conclusion The improved quality standards are specific,accurate and reproducible. They can be used for quality control of compound nasal drops.

关 键 词：复方呋喃西林滴鼻液 HPLC 盐酸麻黄碱 呋喃西林 化学鉴别 

分 类 号：R927[医药卫生—药学]