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目的:制备一种治疗慢性及过敏性鼻炎的复方滴鼻剂。方法:确定制剂的处方组成,建立质控标准,考察制剂的稳定性。结果:选用抗组胺药氯苯那敏及肾上腺素受体兴奋药麻黄碱,辅以抑制细菌性过敏原的庆大霉素,加氯化钠及蒸馏水使成等渗溶液。临床使用效果良好;一次取样可同时测定氯苯那敏和麻黄碱的含量,方法准确,具有良好的线性关系和重现性;稳定性加速试验:含量、pH及外观均无变化。结论:该复方滴鼻剂制备工艺简单,含量测定快速,制剂的稳定性好,可推广应用
Objective: To prepare a compound nasal drops for the treatment of chronic and allergic rhinitis. Methods: To determine the formulation of the formulation, establish quality control standards, study the stability of the preparation. Results: The antihistamine chlorpheniramine and epinephrine receptor stimulant ephedrine, supplemented with bacterial allergen inhibition of gentamicin, add sodium chloride and distilled water to make isotonic solution. The clinical use of good results; a sampling can be simultaneous determination of chlorpheniramine and ephedrine content, accurate, with good linearity and reproducibility; stability accelerated test: content, pH and appearance were not changed. Conclusion: The compound nasal drops preparation process is simple, rapid determination of content, preparation stability, and can be extended to use