Research Of Ambroxol Hydrochloride Glucose Infusion Packed By Multi-layer Co-extruded Injection Film

The ambroxol hydrochloride is an active metabolite of bromhexine and is a new kind of respiratory tract mucus regulator.Injection administration is usually used for treatment of premature and neonatal.At present,the clinical dose for children is hard to control and adverse reactions occur frequently.This article studied a new ambroxol hydrochloride glucose infusion(50ml: ambroxol hydrochloride 7.5mg and glucose 2.5g)used for the treatment of preterm children,which is packaged with multi-layer co-extruded film infusion bag and has a small-low dosage.It aims to provide a safe option for the Clinical Pediatric.In this paper,we investigated the process of ambroxol hydrochloride glucose infusion,selected the materials,established an internal standard of raw materials.The ingredients,potting and sterilization processes were optimized to control the increasing of related substances,ensure the sterilization effect and product quality.Secondly,according to the new package materials’ potential hazards of ambroxol hydrochloride glucose infusion,we made a research on 20 identified subjects.Through screening experiments,the HPLC method of 5 kinds of antioxygens and their degradation products,the GC detection method of styrene monomer,the AAS and ICP-MS methods of 9 kinds of metal ions and the GC method of methylbenzene in ink were both established.The compatibility of product package material was researched to determined the safety of multi-layer co-extruded film infusion bag,including extraction experiment,migration and adsorption experiment.According to the possible raw material impurities of ambroxol hydrochloride and preparation process impurities,a further structure confirmation and inspection of the impurities generated in the preparation production process were studied.The limit of impurity B in the process optimization products was added,and the stability studies of the products proved that the package material has no effect on product quality and the related substances were stable.Ambroxol hydrochloride glucose infusion packed with multi-layer co-extruded film infusion bag has the advantages of small volume,low dosage,new package material and stable quality,which is the best choice for children in clinical rational use of drugs to reduce adverse reactions and decrease the risk of infusion.