氯雷他定口溶膜质量标准的建立
Establishment of Quality Standard for Loratadine Orodispersible Films
杨柳榴 1王兵 1洪丽萍 2王稳奇 2陈芳1
作者信息
- 1. 中国医药工业研究总院医药先进制造国家工程研究中心,上海 201203
- 2. 康芝药业股份有限公司,海南海口 570311
- 折叠
摘要
为控制氯雷他定(1)口溶膜的产品质量,同时为同类剂型质量标准的建立提供参考,根据ICH和NMPA发布的指导原则,参考1普通口服固体制剂的药典标准,以及国外上市口溶膜的质量研究资料,结合1 口溶膜的实际情况,建立了 1 口溶膜的质量标准.对3批1 口溶膜进行了质量检验及稳定性考察.结果显示,自制1 口溶膜的性状、鉴别、有关物质、溶出度、溶化时间、含量、含量均匀度和微生物限度均符合标准规定,提示自制产品稳定性良好,所制定的质量标准可有效控制1口溶膜的产品质量.
Abstract
In order to control the product quality of loratadine(1)orodispersible films and provide references for the establishment of specification for similar dosage forms,a quality standard for 1 orodispersible films had been established based on the guidance principles issued by ICH and NMPA,and referring to the pharmacopoeia standards of 1 oral solid dosage forms and the quality information on orodispersible films marketed abroad,in combina-tion with the characteristics of 1 orodispersible films.Quality inspection and stability investigation of three batches of 1 orodispersible films were carried out.The results showed that the appearance,identification,related substances,disso-lution,disintegration time,content,content uniformity and microbial limits of the self-made 1 orodispersible films were in compliance with the quality standard,indicating that the self-made product had good stability.In conclusion,the quality standard provided could adequately control the product quality of 1 orodispersible films.
关键词
氯雷他定/口溶膜/质量标准/含量均匀度/溶出度/有关物质Key words
loratadine/orodispersible film/quality standard/content uniformity/dissolution/related substance引用本文复制引用
基金项目
国家药典委员会国家药品标准制修订研究课题(2021)(2021Y29)
出版年
2024
NETL
NSTL
万方数据