摘要
口溶膜是一种新型的单层或多层载药膜状制剂,通常不需要用水送服,置口腔中就可被唾液快速溶化。文章介绍了口溶膜的剂型特点、国内外发展概况、处方工艺特点、质量控制的研究内容和一般要求等。对于口溶膜的质量评价,除了包括与普通口服制剂相同的常规检查项目以外,还应根据剂型特点,对特殊的物理、化学、机械等性质进行评价,以确保产品的安全性和有效性。
Orodispersible films are innovative single-layer or multi-layer composite drug-loading films that can be quickly wetted by the patient’s saliva and dissolved in the mouth without the need for drinking water.This review introduces the dosage form characteristics,global development,formulation compositions and process features,research content and general requirements of quality control of orodispersible films.For the quality evaluation of orodispersible films,except for the conventional inspection items of ordinary oral preparations,some special characteristics,such as physical,chemical,and mechanical properties of orodispersible films should also be evaluated based on the dosage form characteristics in order to ensure the safety and effectiveness of the products.
作者
王鹏
张勇
王栋海
杨清敏
WANG Peng;ZHANG Yong;WANG Donghai;YANG Qingmin(Qilu Pharmaceutical Co.,Ltd.,Jinan 250100)
出处
《中国医药工业杂志》
EI
CAS
CSCD
2024年第3期319-325,共7页
Chinese Journal of Pharmaceuticals
关键词
口溶膜
质量评价
质量标准
orodispersible film
quality evaluation
quality standard
