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作 者:石浩强[1] 邵云弟[1] 徐斌[1] 张芳华[1] 杨婉花[1] 翟青[1]
机构地区:[1]上海第二医科大学附属瑞金医院药剂科,上海200025
出 处:《上海医药》2000年第6期28-30,共3页Shanghai Medical & Pharmaceutical Journal
摘 要:目的:比较不同厂家交沙霉素片剂的体外溶出度。方法:采用紫外分光光度法(检测波长232nm)测定国内两个厂家4批交沙霉素片剂的体外溶出度,并以桨法和转篮法加以比较。结果:4批产品的溶出度参数有非常显著的差异(P<0.01)。其中A2产品溶出迅速,在桨法测量中40min可溶出95%以上,而B1产品溶出最慢,同一方法40min仅溶出30%左右。结论:由于不同厂家的交沙霉素片剂差异明显,建议规定详细的溶出标准并严格控制其制剂质量。Objective;To compare in vitro the dissolution rates of different batches of josamycin tablets. Method:The dissolution rates of 4 batches of josamycin tablets from 2 factories were determined with ultraviolet spectrophotometry. Paddle stirring and rotary basket stirring were also compared. Results:Dissolution of the 4 batches of josamycin tablets differed significantly(P<0. 01). Of the 4 batches,the product of batch A2 dissolved most rapidly,more than 95% of it can be dissolved after 40 minutes' paddle stirring. The product of batch B1 dissolved most slowly,only about 30% of it was dissolved after 40 minutes' paddle stirring. Conclusion ; As the dissolution rates of josamycin tablets from different factories differed significantly, it is necessary to set dissolution standard of josamycin tablet and the pharmaceutical companies should control the quality of their products strictly.
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