摘要
目的:考察不同厂家左氧氟沙星片的质量,为,临床选用提供参考。方法:利用紫外分光光度计测定药物含量;采用桨法测定药物的溶出度,提取溶出参数进行统计分析。结果:5个厂家生产的左氧氟沙星片含量均符合规定,各厂产品的溶出参数差异极显著(P<0.01)。A厂样品批间T_(50)和T_d差异无统计学意义(P>0.05),其余各厂样品批间T_(50)和T_d均存在不同程度的差异(P<0.05或P<0.01)。结论:不同厂家生产的左氧氟沙星片质量有差异,A厂质量较稳定。
Objective : To evaluate the quality of levofloxacin tablets from five different factories and provide suggestions for clinical use. Method: Levofloxacin was determined by UV spectrophotometer. The dissolution was investigated with paddle method. Result: The quality of levofloxacin tablets from five factories was all qualified. There were significant differences among their parameters ( P 〈 0.01 ). Except factory A, there were significant differences among three batches from the others in T50 and Td (P 〈 0.05 or P 〈 0.01 ). Conclusion: There are differences in quality of levofloxacin tablets from different factories. The quality of the tablets produced by the factory A is more stable.
出处
《中国药师》
CAS
2008年第2期178-180,共3页
China Pharmacist
关键词
左氧氟沙星片
溶出度
质量考察
Levofloxacin tablet
Dissolution
Quality evaluation