摘要
目的对国内已上市2个厂家右佐匹克隆片进行质量研究,同时与国外原研药进行一致性评价。方法参照国家食品药品监督管理局标准对本品的性状、鉴别、有关物质、含量、含量均匀度等进行研究,并采用不同溶出条件对溶出度进行了考察。结果国内两个厂家的右佐匹克隆片质量符合国家食品药品监督局标准的各项规定;国内上市药在pH1.0和pH4.5溶出介质中的溶出行为与原研片相似,而在pH6.8和水溶出介质中溶出行为与原研片不相似。结论国产的右佐匹克隆片与国外原研药质量均符合标准规定,2个厂家生产的右佐匹克隆片与国外原研片溶出行为不完全一致。
Objective To study the quality of Eszopiclone Tablets of the two domestic manufacturers, and research quality consistency e valuation with original study medicine. Methods The product description, identification, related substances, content, content uniformity were studied Reference to the SFDA Drug Standards. And investigate the Dissolution with Different dissolution conditions. Results the quality of Domestic listed Eszopiclone Tablets is in line with the SFDA Drug Standards;The dissolution characteristics of Domestic listed drug were similar to the Original study medicine in pHI. 0 and pH4.5 Dissolution medium, and the dissolution characteristics of Domestic listed drug were different from the Original study medicine. Conclusion Domestic listed Eszopiclone Tablets and the Original study medicine are in line with the SFDA Drug Standards;The dissolution characteristics between Domestic listed Eszopiclone Tablets and the Original study medicine were Not completely consistent.
出处
《安徽医药》
CAS
2013年第10期1667-1670,共4页
Anhui Medical and Pharmaceutical Journal
关键词
右佐匹克隆片
溶出度
一致性评价
eszopiclone tablets
dissolution
consistency evaluation
