Study on the Delamination of Pharmaceutical Glass Packaging of Sodium Hyaluronate for Injection
Objective:By testing sodium hyaluronate glass packaging and extraction solution,including simulated test and accelerated test,the delamination trend of cillin bottle was investigated.Methods:The inner surface of the pharmaceutical glass container was examined by methylene blue staining and scanning electron microscope,to observe the delamination of pharmaceutical glass packaging.The solution was tested for pH and elemental analysis by ICP-OES.The delamination trend of pharmaceutical glass packaging was evaluated from different angles to predict the internal surface corrosion of glass and the tendency of glass stripping.Results:In the simulation experiment,no obvious delamination occurs in the cillin bottle.In the accelerated experiment,there was a tendency of delamination in the cillin bottle.Conclusion:Through methylene blue staining,scanning electron microscopy,pH and element migration characterization tests,the delamination trend of pharmaceutical glass packaging can be accurately and effectively judged.This article provides an important basis for the compatibility study of sodium hyaluronate pharmaceutical glass packaging.
delaminationcompatibility of pharmaceutical packaging materialselement migrationinternal surface durability
万方数据
维普
