Study On Compatibility Of Non-PVC Three-layer Co-extruded Film

This thesis mainly studies on compatibility of non-PVC three-layer co-extruded film. Compatibility test is one of the major experimental basis for medicine packaging material selection, which is not only the regulatory requirements also is the important content of drug safety and effectiveness evaluation.Non-PVC three-layer co-extruded film soft bag is made from three-layer plastic materials of different melting points, such as polypropylene (PP), polyethylene (PE), polyamide (PA) and a variety of elastic material (SEBS), from which coextruded film is made out under the class100clean conditions. The soft infusion bags quality meets U.S. Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia standards with a very low water permeability, air permeability and mobility, and applicable to most of the drugs. Currently it is gradually replacing glass bottles for infusion packaging. At present, the materials used for soft bags on the market usually are polypropylene (PP), polyamide (PA) and so on.For compatibility study on pharmaceuticals and packaging materials, first of all, we should analyze packaging materials and additives, then through a preliminary stability test, accelerated test and long-term stability test to investigate how packaging materials affect pharmaceutical stability; through compatibility study on drugs and packaging materials, the extent of packaging material components’ migration into the drug and adsorption degree of packaging materials to active ingredient of preparation and functional materials are tested to make sure the packing material can ensure drug quality and stability and its compatibility with drugs is good.In this thesis the research contents mainly includes the determination of antioxidant and migration test, styrene monomer residue detection and migration test,1,3-butadiene monomer residue testing and migration testing, in which antioxidants are oxidation resisting additives in non-PVC three-layer co-extrusion film, with styrene monomer, and1,3-butadiene monomer composition as one of the polymer membrane material of elastic material, the same time, to investigate the membrane’s variation with time under the influence of temperature, humidity, light, hereby the influencing factors for membrane test, acceleration test and the long-term stability are made.Through this pilot study, it aims to find out xtraction method and detection method of non-PVC three-layer co-extruded infusion film, antioxidants in its preparations, styrene monomer,1,3-butadiene monomer with a view to pave the way for the research on the compatibility of products and packaging materials. The establishment of this method can give some lights and methods for the research on the compatibility of drugs and packaging material, help it become a means of products safety supervision, and provide a scientific basis in drug production, packaging, storage and transportation conditions.