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作 者:付金玉[1]
出 处:《哈尔滨医药》2011年第4期250-251,共2页Harbin Medical Journal
摘 要:目的了解和分析阿苯哒唑片的质量情况,以指导临床应用。方法对本单位及市售3个厂家的产品进行质量分析,测定其溶出度、含量并进行比较。结果 3个产品的溶出度均符合药典规定的标准(45 m in〉65.00%),其差别无统计学意义(P〉0.05);3个产品的含量也都符合药典的规定,在标示含量的90.0%~110.0%之间;但3个产品的体外溶出参数T50、Td、T80、M之间的差异有统计学意义(P〈0.01)。结论不同厂家产品的体外溶出参数存在差异,可以导致临床疗效的优劣。应严格按照药典规定控制产品质量,保证临床用药安全、有效。Objective To understand and analyse the quality of Albendazole in order to guide clinical application.Methods This study was performed to measure and compare the dissolution and content of 3 products in this unit and the sales.Results The dissolution rates of 3 products were consistent with the required standard of pharmacopeia(45min65.00%),and the difference had no statistical significance(P〈0.05);the content of 3 products was set as 90.0%-110.0%,which was consistent with the provisions of pharmacopeia too.But the extracorporeal dissolution parameters(T50,Td,T80,M)of 3 products had significant difference(P〈0.01).Conclusion The extracorporeal dissolution parameters of products made by different manufactories have differences,which can result in different clinical effect.The drug manufacture should be strictly in accordance with the provisions of pharmacopeia to control quality and ensure the safety and efficiency of clinical medication.
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