特非那定口服混悬剂的制备及含量测定

Preparation of terfenadine oral suspension and its assay

目的：为满足儿科抗过敏治疗的需要，建立特非那定口服混悬剂的制备和质量控制方法。方法：采用ＣＭＣＮａ作助悬剂，羟苯乙酯作防腐剂，单糖浆为矫味剂，按照制备口服混悬剂的一般方法制备特非那定口服混悬剂；采用非水滴定法测定特非那定的含量。结果：制剂稳定，平均回收率９９．１％，ＲＳＤ为０．７％。结论：特非那定可以制成口服混悬剂应用于临床。

OBJECTIVE :To satisfy the needs of paediatrics with allergy infection,to establish the methods of preparation and quality control for terfenadine oral suspension. METHODS :CMCNa was used as suspending agents,ethylparaben preservative,and simple syrup corrects taste.The oral suspension were perpared according to the ordinary method of manufacturing.The terfenadine was determined by nonaqueous titration. RESULTS :The oral suspensions have good stability,its quality can be controlled.The average recoveries are 99.1% with RSD 0.7%. CONCLUSION :Terfenadine could be prepared as oral suspension for clinical application.