Compatibility of medicinal brown medium borosilicate glass ampoule and the ambroxol hydrochloride solution for inhalation
Objective To determine the compatibility between medicinal brown medium borosilicate glass ampoule and ambroxol hydrochloride solution for inhalation.Methods SEM,ICP-MS and other methods were used to determine the interaction between drugs and packaging materials through simulation and migration experiments.The compatibility was evaluated according to toxicological research data.Results After 6 months of accelerated stability test,the changes of elements in ambroxol hydrochloride solution were measured.Seven elements such as Si and B increased more than 40％,but did not exceed the daily maximum allowable intake.The area or quantity of erosion spots on the surface of the glass ampoule increased with the extension of accelerated storage time.After 24 months of long-term stability test,there was no significant change in the elements in ambroxol hydrochloride solution and the surface of glass ampoules.Conclusion There tends to be interaction between medicinal brown medium borosilicate glass ampoule and ambroxol hydrochloride solution.The validity period of this product should be shortened as much as possible,and attention should be paid to the interaction.
ambroxol hydrochloride solution for inhalationmedicinal brown borosilicate glass ampoulecompatibility
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