Study on the quality standard and application of polyoxyl(15)hydroxystearate
10.19778/j.chp.2025.02.004
- VernacularTitle:聚氧乙烯(15)羟基硬脂酸酯质量标准及应用研究
- Author:
Jinhua CHEN
1
;
Mingqing CHEN
1
;
Zhengyu LIU
1
;
Chunmeng SUN
1
;
Lei JIANG
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,南京 210009;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:
polyoxyl(15)hydroxystearate;
quality standard;
non-ionic surfactant;
in vitro and in vivo safety
- From:
Drug Standards of China
2025;26(2):135-144
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To study and establish the quality standard of Polyoxyl 15 hydroxystearate(HS15),a phar-maceutical excipient,and systematically evaluate its functionality-related characteristics and safety.HS15 was applied to the preparation of docetaxel(DTX)injection to further investigate the safety and pharmacokinetic char-acteristics of the injection in vitro and in vivo.Methods:Based on the general USP-NF2024,EP11.0 and the fourth general rules of the Chinese Pharmacopoeia 2020 edition,the quality standards of HS15 were studied.Combined with the functional properties of surfactants,the critical micelle concentration of HS15 was investigated,and its safety was investigated by hemolysis test and vascular irritation test in vitro.HS15 was further applied to the preparation of DTX injection,and the safety and efficacy of the preparation were comprehensively evaluated by in vitro cytotoxicity test and in vivo pharmacokinetic study.Results:According to the experimental results and the pharmacopoeia of various countries,the quality standard of HS15 was preliminarily formulated.When the concen-tration of HS15 was 1 mg·mL-1,the hemolysis rate was about0.2%,the vascular irritation was small,and the DTX injection was safe in vitro and in vivo.The pharmacokinetic behavior was in line with expectations.Conclusion:This study successfully established the quality standard of HS15,and its functional correlation index research and safety evaluation strategy can provide reference for the quality control of similar excipients.The appli-cation of HS15 in the preparation of DTX injection provides a theoretical and experimental basis for its application in the development of insoluble antitumor drug injection.
