特非那定凝胶滴鼻剂的研制

Preparation of terfenadine gel nasal drops

目的：设计研究一种治疗变应性鼻炎、过敏性皮肤病的特非那定凝胶剂的处方和制备工艺，建立制剂含量测定的方法，并对其稳定性进行初步探讨。方法：以Ｃａｒｂｏｐｏｌ９４１作为凝胶基质；采用分光光度法测定含量。加速试验法考查制剂的稳定性。结果：制剂的粒度小且均匀，分散性好。建立的分析方法能排除辅料和降解产物的干扰，准确测定含量。结论：特非那定凝胶滴鼻剂制备工艺简单，易于工业化生产，含量测定的平均回收率为１００．９％，相对标准差（ＲＳＤ％）为０．９１，室温贮存稳定性好。

OBJECTIVE :The prescription and preparation of terfinadine gel nasal drops in the treatment of allergic rhinitis and allergic dermatoigical were designed and studied.The assay of the content was set up and its stability was discussed primarily. METHODS: Carbopol was used as base,the content was determined by spectrophotometry. RESULTS: The preparation was homogeneous with small particles.The dispersity was good.The assay was precise and specific without the distrubation of the additive and degration products. CONCLUSION: The preparation process of the gel nasal drops was simple and easy for industrialization.The average recovery of the terfenadine was 100.9%(RSD 0.91%,n=5).The product is stable when storing at room temperature.