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目的 :对复方利巴韦林滴鼻液的制备及质控方法进行研究。方法 :参照同类制剂 ,选择利巴韦林及盐酸麻黄碱作为主药 ,辅以甘油、氯化钠、苯扎溴铵配成滴鼻液 ,分别采用分光光度法测定利巴韦林含量 ,中和法测定盐酸麻黄碱含量。结果 :利巴韦林的平均回收率为 99.9% (RSD =0 .2 % ) ,盐酸麻黄碱的平均回收率为 10 0 .2 % (RSD =0 .3% )。结论 :本制剂制备工艺简单 ,稳定性好 ,含量测定方法简便易行 ,结果准确 ,适用于医院制剂室配制和进行质量控制。
Objective: To study the preparation and quality control of compound ribavirin nasal drops. Methods: With reference to similar preparations, ribavirin and ephedrine hydrochloride were selected as the main drugs, supplemented with glycerol, sodium chloride and benzalkonium bromide as nasal drops. The content of ribavirin was determined by spectrophotometry. Determination of ephedrine hydrochloride content. RESULTS: The average recovery of ribavirin was 99.9% (RSD = 0.2%) and the average recovery of ephedrine hydrochloride was 10.2% (RSD = 0.3%). Conclusion: The preparation has simple preparation process, good stability, simple and convenient determination of content, accurate result and suitability for preparation and quality control of the preparation room of a hospital.