Research on the method for measuring the properties of film forming materials
10.19778/j.chp.2025.05.010
- VernacularTitle:成膜类药用辅料性能测定方法研究
- Author:
Zhengyu LIU
1
;
Bujin YIN
1
;
Yumeng HU
1
;
Weijie ZHAO
1
;
Chunmeng SUN
1
;
Jiasheng TU
1
Author Information
1. 中国药科大学药学院药用辅料及仿创药物研发评价中心,国家药品监督管理局药物制剂及辅料研究与评价重点实验室,南京 210009
- Publication Type:Journal Article
- Keywords:
film forming pharmaceutical excipients;
free membrane;
tensile strength and elongation;
water vapor permeability;
flexibility;
solubility
- From:
Drug Standards of China
2025;26(5):512-520
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study the functional characteristics of protective,barrier,and controlled release of film forming pharmaceutical excipients in formulations,establish a method for measuring the properties of film forming pharmaceutical excipients,and evaluate their performance.Methods:By preparing free films of different film forming pharmaceutical excipients and referring to national standards and literature research systems,a testing sys-tem covering key indicators such as tensile strength and elongation,water vapor permeability,flexibility,and solu-bility was constructed.Results:Through comparative testing of multiple brands of excipients,all detection methods showed good discriminability and reproducibility,indicating the applicability and stability of the methods.Conclusion:Evaluating the properties of film forming pharmaceutical excipients through a successfully constructed method not only reveals the structure-activity relationship between material structure and functional characteristics,but also provides technical support for the construction of functional index databases for pharmaceutical excipients.This research result can be used to guide the development of new film forming pharmaceutical excipients and pro-vide experimental basis for industry standard setting,meeting the needs of drug research and quality supervision.
