Investigation on elemental migration and internal surface delamination of ambroxol hydrochloride injection in brown middle borosilicate glass ampoules
10.19778/j.chp.2024.03.017
- VernacularTitle:棕色中硼硅玻璃安瓿包装盐酸氨溴索注射液的元素迁移量及内表面脱片的研究
- Author:
Qile YANG
1
;
Zongsheng LI
;
Lei LI
;
Haixiang ZHANG
;
Congying LI
Author Information
1. 山东力诺特种玻璃股份有限公司,济南 251600
- Keywords:
ambroxol hydrochloride injection;
brown middle borosilicate glass ampoule;
migration quantity deter-mination;
internal surface detachment;
ICP-OES;
SEM
- From:
Drug Standards of China
2024;25(3):313-320
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To examine the effect of brown midle borosilicate glass ampoules on the drug safety of ambr-oxol hydrochloride injection.Methods:By simulating the storage conditions of ambroxol hydrochloride injection,experimental studies were designed using inductively coupled plasma emission spectroscopy(ICP-OES)and scan-ning electron microscopy(SEM)to investigate element migration and internal surface detachment.Results:The Si content in the injections increased over time,and after 0 to 48 months of various stages of testing,the inner surface of the glass was intact,with no detachment or erosion;the migration of various target elements,such as Cd,Pb,As,Hg,etc.,into the injections took place,but the contents were in accordance with the limits set by the relevant regulations.Conclusion:Brown middle borosilicate glass ampoule packaging for ambroxol hydrochloride injection is safe and stable for 48 months.Brown middle borosilicate glass ampoule can be used as a good container for ambr-oxol hydrochloride injection.
