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目的 :比较 5种克拉霉素片剂体外溶出度。方法 :利用HPLC测定克拉霉素片剂含量 ,按USP2 3版采用转篮法测定克拉霉素片剂在醋酸钠缓冲液中的溶出度。结果 :9min平均累积溶出百分率产品A ,C >D ,E >B。A和C ,E和D差别无显著意义 (P >0 .0 5) ,余存在极显著差异 (P <0 .0 1)。 18min时 ,产品A已基本溶出完全 ,其余产品在 4 5min时仍未完全溶出。 5个厂家生产克拉霉素片剂 4 5min时在醋酸钠缓冲液中的溶出量均大于标示量的70 % ,符合中国药典 1995版的规定。结论 :A厂产品溶出度优于其他产品 ,C厂产品 30min前溶出度优于D ,E ,B。
Objective: To compare the in vitro dissolution of five clarithromycin tablets. Methods: The content of clarithromycin tablets was determined by HPLC. The dissolution rate of clarithromycin tablets in sodium acetate buffer was measured by the spin basket method according to USP2 3. Results: The average cumulative dissolution rate of 9min product A, C> D, E> B. There was no significant difference between A, C, E and D (P> 0.05), with significant difference (P <0.01). 18min, the product A has been completely dissolved completely, the remaining products in 4 5min still not completely dissolved. 5 manufacturers clarithromycin tablets 4 5min dissolution in sodium acetate buffer were greater than 70% of the labeled amount, in line with the provisions of the Chinese Pharmacopoeia 1995 edition. Conclusion: The dissolution rate of product A is better than that of other products. The dissolution rate of product C is better than that of D, E and B 30min before.