摘要
目的:对自研和参比阿哌沙班片进行体外鼻饲对比研究,为评价其质量一致性提供依据。方法:以外观、沉降高度、粒度分布、pH和回收率试验为特征指标,进行体外鼻饲的对比研究。结果:自研和参比阿哌沙班片在外观、沉降高度、粒度分布、pH和回收率方面的试验结果均相似(均P>0.05)。结论:两制剂体外鼻饲行为具有一致性。
Objective:To conduct a comparative study of in vitro nasal feeding between the self-developed apixaban tablets and the reference preparations to provide a basis for evaluating its quality consistency.Methods:A comparative study of in vitro nasogastric feeding was conducted with appearance,sedimentation test,particle size distribution,pH,and recovery rate as characteristic indicators.Results:The test results showed that both apixaban tablets were similar in appearance,sedimentation test,particle size distribution,pH and recovery rate(all P>0.05).Conclusion:The in vitro nasal feeding behavior of both apixaban tablets is consistent.
作者
许俊博
金珠
荆慧敏
营亚萍
尹朋朋
XU Junbo;JIN Zhu;JING Huimin;YING Yaping;YIN Pengpeng(China Resources Double-Crane Pharmaceutical Co.,Ltd.,Beijing 100120,China)
出处
《上海医药》
2025年第11期92-96,共5页
Shanghai Medical & Pharmaceutical Journal
关键词
阿哌沙班片
体外鼻饲对比
质量一致性
apixaban tablets
comparison of in vitro nasal feeding
quality consistency
