论文部分内容阅读
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: To design and prepare a formulation and preparation process of terfenadine gel for the treatment of allergic rhinitis and allergic skin diseases, and to establish a method for the determination of formulation content. The stability of this preparation is also discussed. Methods: Carbopol941 was used as the gel matrix; the content was determined by spectrophotometry. Accelerated test method to examine the stability of the preparation. Results: The preparation of small and uniform particle size, good dispersion. The established analytical methods can eliminate the interference of excipients and degradation products, accurately determine the content. CONCLUSION: The preparation method of terfenadine nasal drops is simple and easy to produce industrially. The average recovery of terbutaline gel is 100.9%, the relative standard deviation (RSD%) is 0.91 and the storage stability at room temperature is good.