市售固体剂型罗红霉素制剂溶出行为的考察

Investigation on the dissolution behavior of roxithromycin from its solid dosage forms

目的 考察不同制药公司生产的罗红霉素制剂 (片 ,胶囊 ,颗粒剂 )的体外溶出度。方法 以硫酸溶液 (75→ 10 0 )为显色剂 ,用分光光度法测定罗红霉素溶出度。结果 不同制药公司及同一公司生产的不同批号的片和胶囊的溶出度基本上能达到药典规定标准 (即 4 5min溶出量分别为≥ 80 %和≥ 75 % )。各公司生产的颗粒剂 ,其溶出度差异显著。结论 建议对颗粒剂的溶出度制定法律标准。

OBJECTIVE: To investigate the dissolution behavior of roxithromycin tablets, capsules and granules from different pharmaceutical manufacturers. METHODS: The UV spectrophotometry method was applied to determine the dissolution of roxithromycin preparations with sulfuric acid solution (75&rarr100) as the color developing agent. RESULTS: The dissolution of the tablets and capsules were found accord with the standard of Ch. P(dissolution of 45 min had achieved≥80% and ≥75% respectively). Great differences of the dissolution rate and extent of roxithromycin from granules manufactured by various pharmaceutical companies were observed. CONCLUSION: A criteria for the dissolution of roxithromycin granules was strongly suggested.