Interpretation of the Standard for Plastic Bottle Systems and Components for Eye Drops in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
10.3870/j.issn.1004-0781.2025.07.004
- VernacularTitle:2025年版《中华人民共和国药典》滴眼剂用塑料瓶系统及组件标准解读
- Author:
Yong SHEN
1
;
Xiaowen BO
;
Xueting LIU
;
Changshuai ZHAO
;
Xin WANG
;
Lei CHEN
Author Information
1. 山东省医疗器械和药品包装检验研究院,国家药品监督管理局药品包装材料质量控制重点实验室,济南 250101
- Publication Type:Journal Article
- Keywords:
Plastic bottle systems and components for eye drops;
Pharmacopoeia of the People's Republic of China;
Standard interpretation
- From:
Herald of Medicine
2025;44(7):1040-1044
- CountryChina
- Language:Chinese
-
Abstract:
To provide an in-depth interpretation of the background and rationale behind the development of the standard for plastic bottle systems and components for eye drops as outlined in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred as the Chinese Pharmacopoeia),to facilitate stakeholders thorough understanding of the standard content,and to offer a strong support for its subsequent smooth implementation.Starting from the background of standard construction,an in-depth exploration was conducted into the quality control requirements for plastic bottle systems and components used for eye drops,and a detailed analysis was provided of the logic and rationale behind the establishment of quality control items.Related parties should develop product quality standards based on the general requirements of the guidelines for plastic materials and containers used in pharmaceutical packaging,taking into account the specific characteristics and practical application scenarios of plastic bottle systems and components for eye drops.The standard for plastic bottle systems and components for eye drops in the 2025 edition of the Chinese Pharmacopoeia are more scientific and flexible,which will help improve the quality of eye drop products in our country while also promoting innovation and development in the eye drop packaging industry.
