对乙酰氨基酚片沿刻痕分割后的药学质量评价  

Tablet Scoring Feature Evaluation for Acetaminophen Tablets after Tablet-splitting

作　　者：肖艳 高永坚 梁标志 史紫娟 梁思韵 赵淑晶 XIAO Yan;GAO Yong-jian;LIANG Biao-zhi;SHI Zi-juan;LIANG Si-yun;ZHAO Shu-jing(Sinopharm Group Guangdong Medi-World Pharmaceutical Co.,Ltd.,Foshan 528303,China)

机构地区：[1]国药集团广东环球制药有限公司,广东佛山528300

出　　处：《海峡药学》2023年第1期47-50,共4页Strait Pharmaceutical Journal

摘　　要：目的本研究以有中刻痕的对乙酰氨基酚片(500 mg)为例,对刻痕片进行药学质量评价。方法分别以手掰和切药器分割法将受试片剂沿中刻痕分割成2个半片,考察分割后片剂的重量损失、重量差异、脆碎度、溶出度和稳定性。结果单面刻痕的对乙酰氨基酚片利于分割,且分割后损失率小于3.0%,重量差异均在85%~115%之间,脆碎度结果小于1.0%,且单半片溶出行为与整片相似。此外,室温放置90 d,分割后片剂的含量、杂质水平和溶出度相对于刚分割时没有明显变化。结论有单面刻痕的对乙酰氨基酚片可以被均匀的分割,能正常释放,有利于临床的剂量调整。OBJECTIVE This study was conducted to evaluate the pharmacological quality of acetaminophen tablets(500 mg)with a medium indentation.METHODS The tablets were divided into 2 halves along the middle indentation by hand-breaking and tablet splitter,and the mass loss,weight variation,friability,dissolution and stability of the tablets after division were investigated.RESULTS The results showed that the acetaminophen tablets with single-sided scores were easy to split,and the loss mass was less than 3.0%after splitting,the weight variation was between 85%and 115%,the friability was less than 1.0%,and the dissolution curve of single half tablets was similar to that of whole tablets.Furthermore,there was no significant difference in drug content,impurities and solubility between the two halves before and after the split tablets were stored at room temperature for 90 days.CONCLUSION Acetaminophen tablets with one-sided indentations can be evenly divided and can be released normally,which is beneficial for clinical dose adjustment.

关 键 词：对乙酰氨基酚 刻痕片 分割性 稳定性 

分 类 号：R927[医药卫生—药学]