摘要
目的评价国产氯雷他定片的质量现状。方法采用法定标准方法结合探索性研究对样品进行评价,统计分析检验结果。结果按法定标准检验248批样品,均符合规定,合格率为100%;探索性研究建立的HPLC法能有效分离氯雷他定及其5个杂质。采用生物药剂学分类系统(BCS)Ⅱ类药物的两点测定法分析样本的溶出度能区分氯雷他定片质量的优劣。结论本品按各执行标准检验,总体合格率较好,通过探索性研究拟定的方法有助于揭示产品的质量问题,引导企业进行制剂工艺改进,提高药品质量。
Objective To evaluate the quality status of loratadine tablets. Methods Using statutory testing methods and combine with the exploratory research to evaluate the quality of loratadine tablets by statistical analysis of the results. Results The statutory standard methods showed 248 batches of loratadine tablets samples were qualified, the qualified rate was 100%. Exploratory studies have shown that the improved HPLC method of related substances could be separated from loratadine and five impurities with a good resolution. Adopting two points for biopharmaceutics classification system（BCS）Ⅱ drugs＇ assessment could distinguish the quality of the dissolution of loratadine tablets. Conclusion At present the most products quality of loratadine tablets can meet the current specifications. The exploratory research suggests that the new-established method can be used to improve the quality specification and is suitable for controlling the quality of this drug. The quality of domestic-made preparations needs to be improved.
作者
王玉
郑淑凤
郭伟斌
唐立超
黄剑英
李玲玲
WANG Yu;ZHENG Shufeng;GUO Weibin;TANG Lichao;HUANG Jianying;LI Lingling(Xiamen Institute for Food and Drug Control,Xiamen 361012,China)
出处
《药物评价研究》
CAS
2018年第7期1256-1259,共4页
Drug Evaluation Research
基金
厦门市重大科技项目(3502Z20121035)
关键词
氯雷他定片
质量评价
探索性研究
loratadine tablets
quality evaluation
exploratory research
