Thermoplastic elastomer material, preparation thereof and method for manufacturing medicinal bottle stopper by using the same

Abstract

The invention provides thermoplastic elastomer materials used for a bottle cork for manufacturing medicines, a preparation method thereof and a method for applying the bottle cork for manufacturing medicines thereof. The materials are prepared by the following components: styrene copolymer or rubber materials as well as polyolefine matters. The styrene copolymer is PP or PE; besides, the materials also contain a plasticizer and a loading agent, contain or do not contain a compatibilizer, contain or do not contain an antioxidant, contain or do not contain an antistatic agent, contain or do not contain adhesion preventives. The preparation method thereof includes the steps of drying the materials, fusing a reaction kettle, using a plastic extruding machine to extrude the materials, using a cooling water slot to cool and shape the materials, using a hauling machine to haul and cut off the materials, and the like. The thermoplastic elastomer materials provided by the invention have the advantages of stable chemical property, no poison, low polarity and good rebound resilience.

Description

technical field [0001] The invention relates to a thermoplastic elastomer material (TPE) for pharmaceutical bottle stoppers, a preparation method thereof and a method for using the same to manufacture medicinal bottle stoppers. Background technique [0002] Drugs have certain biological and chemical activities, and are special substances used by human beings for prevention, treatment, health care and reproduction. Ensuring the quality of medicines and ensuring the safety of medicines are important matters. For this reason, for the containers and materials of pharmaceutical packaging, especially the packaging medicinal corks of injection medicines directly used in the human body, it is necessary to use stable chemical properties, good sealing performance, direct contact with medicines, and stable quality of medicines. Elastomer materials used to make pharmaceutical stoppers for injection pharmaceutical packaging. [0003] In the past, natural rubber was used to make medicin...

AI Technical Summary

Problems solved by technology

However, due to the wide variety of medicines with different physical and chemical properties; the current formulation of pharmaceutical halogenated butyl rubber stoppers is relatively single, and it is difficult to meet the requirements of various drug quality for pharmaceutical halogenated butyl rubber stoppers

[0008] (2) Since the surface of the medicinal halogenated butyl rubber cork forms a very fragile and incomplete molecular rubber film, it cannot completely wrap the filling and reinforcing agent in the rubber compounding system, and it is easy to wear and tear. It is easy to release insoluble substances such as calcium carbonate, kaolin, titanium dioxide and other reinforcing fillers, which will cause visible foreign matter and insoluble particles in injection medicines, especially infusion medicines, to exceed the standard, thus affecting the quality of medicines and medication safety

[0009] (3) Use inert polymer materials such as Teflon (TEFULO) to coat the surface of pharmaceutical halogenated butyl rubber stoppers to make film-coated (coated) rubber stoppers to solve the above problems (1) and (2) , will increase the manufacturing cost of medicinal bottle stoppers. At the same time, because the polymer film is hard and not tightly sealed with the container, it is easy to cause problems such as leakage of the packaging liquid and bacterial contamination.

However, the silicone oil coated on the surface of the pharmaceutical halogenated butyl rubber stopper and the water-repellent substance in the rubber compounding agent diffuse outward, affecting the quality stability of individual drugs; at the same time, a "water-repellent oil film" is formed on the inner surface of the drug container, causing Injection medicines, especially the phenomenon of "hanging beads" (hanging water) on the inner surface of glass bottles of infusion medicines

[0011] (5) Medical halogenated butyl rubber stoppers are prone to acupuncture and chipping during the clinical medication process, causing medication safety problems

[0012] (6) Since halogenated butyl rubber is a polar polymer and has adhesiveness, the medicinal halogenated butyl rubber stopper is easy to absorb dust and fibers, which affects the quality of medicines

It is very difficult to clean and remove, and it has become a quality problem that the pharmaceutical industry pays attention to.

[0013] (7) Pharmaceutical halogenated butyl rubber is a thermosetting elastomer, and the scraps and defective products in the manufacturing process cannot be recycled and reused; pharmaceutical halogenated butyl rubber medical bottle stoppers are also disposable consumables. waste of resources and pollution of the environment

[0014] (8) The manufacture of medicinal halogenated butyl rubber medicinal bottle stoppers requires a long production process, strict production environment requirements, high factory construction costs, and high production energy consumption.