Pharmaceutical thermoplastic elastomer bottle stopper and preparation method thereof

Abstract

The invention relates to a medicinal thermoplastic elastomer bottle stopper, which comprises, by mass: 60-65% of SEBS (styrene-ethylene-butylene-styrene), 20-25% of PP (polypropylene), 1-5% of PE, 10-15% of a filler, 0.2-0.3% of toner, and 0.1-0.2% of an antioxidant. The invention also discloses a preparation method of the medicinal thermoplastic elastomer bottle stopper, and the method includes the steps of: weighing materials according to the formula, conducting stirring and mixing, carrying out extrusion granulation, and then performing injection molding, silicification and packaging, thus obtaining the medicinal thermoplastic elastomer bottle stopper. The medicinal thermoplastic elastomer bottle stopper provided in the invention has the advantages of stable chemical performance, no toxicity, security, no fragmentation, low polarity and good resilience, thus being in accordance with the "standards of packaging materials and containers in direct contact with drugs".

Description

technical field [0001] The invention relates to a medicinal thermoplastic elastomer bottle stopper and a preparation method thereof. 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 medicinal stoppers. Natural rubber comes from the gum juice of the rubber tree, which contains: gums,...

AI Technical Summary

Problems solved by technology

However, due to the wide variety of drugs and different physical and chemical properties, the current formula of pharmaceutical halobutyl rubber stoppers is relatively single, and it is difficult to meet the requirements of various drug quality for medicinal halobutyl rubber stoppers;

[0007] (2) Since the surface of the pharmaceutical halogenated butyl rubber cork forms a very fragile and incomplete molecular rubber film, it cannot completely wrap the filler and reinforcing agent in the rubber formula system, and it is easy to wear and tear. The release of insoluble substances such as calcium carbonate, kaolin, titanium dioxide and other reinforcing fillers will cause visible foreign matter and insoluble particles in injection medicines, especially infusion medicines, to exceed the standard, which may affect the quality and safety of medicines;

[0008] (3) The surface of pharmaceutical halogenated butyl rubber stoppers is coated with polymer inert materials such as Teflon (TEFULO) to make film-coated (coated) rubber stoppers to solve the above problems (1) and (2). It will increase the manufacturing cost of medicinal bottle stoppers. At the same time, due to the hard polymer film material, it is not tightly sealed with the container, which may easily cause problems such as leakage of the packaging liquid and bacterial contamination;

[0009] (4) Medical halogenated butyl rubber stoppers are prone to needle-punched chipping during the clinical medication process, causing medication safety problems;

[0010] (5) Since halogenated butyl rubber is a polar polymer and has adhesive properties, pharmaceutical halogenated butyl rubber stoppers are very easy to absorb dust and fibers, which affects the quality of medicines

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

[0011] (6) Pharmaceutical halogenated butyl rubber is a thermosetting elastomer, and the waste and defective products in the manufacturing process cannot be recycled and reused; pharmaceutical halogenated butyl rubber medical bottle stoppers are disposable consumables, causing waste of resources and pollution of the environment;

[0012] (7) To manufacture medicinal halogenated butyl rubber medicinal bottle stoppers, the production process is long, the production environment is strict, the construction cost is high, and the production energy consumption is high

However, the preparation method of the medicinal bottle stopper provided by the invention is relatively complicated, and the cost is high, which is unfavorable for industrial application

Moreover, the polyolefin used in this patent is PP or PE, and the improvement of the mechanical properties of thermoplastic elastomers by simply adding PP or PE is very limited

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