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复方西替利嗪滴鼻剂的制备及质量控制
引用本文:任耘,崔琳,李继新.复方西替利嗪滴鼻剂的制备及质量控制[J].中国医院药学杂志,2004,24(9):546-547.
作者姓名:任耘  崔琳  李继新
作者单位:1. 天津医科大学总医院,天津,300052
2. 天津医科大学药学系99级实习生
摘    要:目的:研制复方西替利嗪滴鼻剂,并对其质量进行控制.方法:建立HPLC法测定制剂中主药盐酸西替利嗪和盐酸麻黄碱的含量,用正交试验法筛选分散介质最佳配方.结果:盐酸西替利嗪和盐酸麻黄碱的平均回收率分别为99.56%和101.12%,RSD分别为1.13%及1.02%(n=3),该制剂对黏膜无刺激性.结论:该滴鼻剂制备工艺简单,质量可控,性质稳定,适于医院制剂.

关 键 词:盐酸西替利嗪  盐酸麻黄碱  滴鼻剂  正交试验法  质量控制
文章编号:1001-5213(2004)09-0546-02
修稿时间:2003年11月15

Preparation and quality control of compound cetirizine nasal drops
REN Yun,CUI Lin,LI Ji-xin.Preparation and quality control of compound cetirizine nasal drops[J].Chinese Journal of Hospital Pharmacy,2004,24(9):546-547.
Authors:REN Yun  CUI Lin  LI Ji-xin
Abstract:OBJECTIVE To study the preparation of compound cetirizine nasal drops and control its quality. METHODS The method of determination of cetirizine hydrochloride and ephedrine hydrochloride by HPLC was established. Optimum formulation was screened with orthogonal design test. RESULTS The average recoveries of cetirizine hydrochloride and ephedrine hydrochloride were _99.56% and _101.12%, respectively, and RSD were _1.13% and _1.02%, respectively(n=3). The nasal drops had no irritation on nasal membranes. CONCLUSION This nasal drops can be easily prepared. The quality can be controlled and the property is stable. It's suitable for hospital preparation.
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