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复方西替利嗪滴鼻剂的制备及质量控制

Preparation and quality control of compound cetirizine nasal drops

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【作者】 任耘崔琳李继新

【Author】 REN Yun, CUI Lin, LI Ji-xin (General Hospital of Tianjin Medical University,Tianjin 300052,China)

【机构】 天津医科大学总医院天津医科大学药学系天津医科大学总医院 天津30005299级实习生天津300052

【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 ,适于医院制剂

【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.