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 99.5 6 %和10 1.12 % ,RSD分别为 1.13%及 1.0 2 % (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 。
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.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2004年第9期546-547,共2页
Chinese Journal of Hospital Pharmacy
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
cetirizine hydrochloride
ephedrine hydrochloride
nasal drops
ort hogonal design test
quality control