Formulation and Interpretation of the Measuring Method of Silicone Oil in Prefilled Syringe
10.3870/j.issn.1004-0781.2025.07.010
- VernacularTitle:预灌封注射器硅油量测定法制订与解读
- Author:
Changshuai ZHAO
1
;
Xueting LIU
;
Aijuan LIU
;
Xiaoyi MENG
;
Yong SHEN
;
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:
Prefilled syringe;
Barrel;
Silicon oil content;
Gravimetric method;
Ethyl acetate
- From:
Herald of Medicine
2025;44(7):1070-1073
- CountryChina
- Language:Chinese
-
Abstract:
Objective To formulate the 2025 edition of the Pharmacopoeia of the People's Republic of China of prefilled syringe silicone oil determination method,and to interpret the method content.Methods The prefilled syringe was added silicone solvent ethyl acetate to the roll edge of the sleeve and let it stand for extraction for 5 minutes,then put the silicon solvent in the evaporating dish dried at 105 ℃ to constant weight,then add 1mL ethyl acetate into the sleeve for rinsing and placing in the same evaporating dish,and then dry in a water bath at 105℃ to constant weight.The content of silicone oil in the sleeve of the prefilled syringe was calculated according to the quality difference.Results The reliability of the experimental method was verified by the ultimate extraction test,standard recovery test,and precision investigation.The results showed that the ultimate extraction could be achieved after 5 minutes of extraction with ethyl acetate.The recovery rate of the method was 100.0％-101.6％,and the precision was 3.5％.Conclusion The formulation of the determination method refers to the measurement method of silicone oil content in relevant standards at home and abroad,combined with the problems existing in the measurement of silicone oil content in daily tests,to further improve the operability of the detection method,the method is simple,efficient,feasible and reliable.
