国产左氧氟沙星片的质量评价  

Quality assessment of domestic levofloxacin tablets

作　　者：吴静萍 陈茜 刘钐 林晨煦 伍雯琦 高丹玲 Wu Jing-ping;Chen Qian;Liu Shan;Lin Chen-xu;Wu Wen-qi;Gao Dan-ling(Fujian Institute for Food and Drug Quality Control,Fuzhou 350001)

机构地区：[1]福建省食品药品质量检验研究院抗生素室,福州350001 [2]福建省食品药品质量检验研究院,福州350001

出　　处：《中国抗生素杂志》2020年第3期234-240,共7页Chinese Journal of Antibiotics

摘　　要：目的评价国产左氧氟沙星片的质量现状并分析存在的问题。方法按照2018年国家药品抽检计划总体要求,采用法定标准检验方法和探索性研究方法进行检验和统计分析。结果按法定标准检验97批次样品,合格率为100%。探索性研究对本品主要杂质的来源与结构进行确证,明确其杂质水平主要与原料药质量有关;本品与原研药在各溶出介质中的溶出行为存在不同程度的差异,尤以0.1g规格片的差异更为显著,提示仿制药一致性评价工作中,应重点关注0.1g规格片的一致性;0.5g规格刻痕片的分割能力不及原研药,存在用药剂量不准确的风险。结论左氧氟沙星片现行质量标准可行,国产左氧氟沙星片生产工艺控制良好,质量较稳定均一,质量总体评价较好。0.5g规格刻痕片的分割能力有待进一步提高。Objective To evaluate the quality status of domestic levofloxacin tablets. Methods According to the general requirements of national assessment programs in 2018, statutory testing methods combined with the exploratory research and statistical analysis of the results were used to evaluate the quality of domestic levofloxacin tablets. Results According to the statutory standards for the examination of the 97 batches of samples, the qualified rate was 100%. According to the exploratory research, the sources and structures of major impurities were confirmed, and the content of impurities was mainly influenced by the active pharmaceutical ingredient. The dissolution behaviors of domestic tablets were different compared with the original tablets, especially the domestic 0.1 g tablets. The quality of 0.1 g tablets should be fully considered in evaluation of quality and efficacy consistency. The splitting results of domestic 0.5 g scored tablets were inferior to the original tablets. There may be dosage security issues with scored tablets. Conclusions The official quality standards of levofloxacin tablets were effective to control the quality. The results showed that the production process and quality of product were stable. The quality of levofloxacin tablets was satisfactory in general. An improvement was put forward to promote the splitting result of 0.5 g scored tablets.

关 键 词：左氧氟沙星片 质量评价 溶出行为 刻痕片 

分 类 号：R978.1[医药卫生—药品] R917[医药卫生—药学]