Medicinal butyl rubber stopper with plastic skeleton and its production

Abstract

A butyl rubber plug with plastic skeleton for medicine features that its plastic skeleton has a central through hole and two rings of holes for fixing the sulfurized butyl rubber on its surface. Its preparing process includes such steps as injection molding to obtain a plastic skeleton, pre-treating the plastic skeleton, putting it in lower die, covering it with the unsulfurized butyl rubber flakes, closing die set, heating to 150-165 deg.C while pressurizing to 7-12 MPa, sulfurizing for 10-15 min, cooling, demoulding, and removing excessive edge.

Description

technical field [0001] The invention relates to a medical butyl rubber stopper, in particular to a medical butyl rubber stopper comprising a plastic skeleton. Background technique [0002] Butyl rubber medical bottle stoppers provide a guarantee for the preservation of pharmaceutical packaging with its unique chemical stability, excellent sealing and self-sealing properties, and high-temperature disinfection performance. However, halogenated butyl rubber, like other rubbers, has no elasticity, only plasticity, and is easy to be molded into any shape. In order to endow medical rubber stoppers with suitable physical properties such as hardness, strength and tear strength, to meet the requirements of pharmaceutical production and clinical use, It is necessary to add a proper amount of additives and fillers based on inorganic materials to the main material, and the cork products are hardened by vulcanization process to have use value. Such substances account for about 50% of the...

AI Technical Summary

Problems solved by technology

[0003] During the implementation of the national trial standard, it was found that due to better control of the content of residue on ignition, although the content of butyl rubber is relatively increased, the hardness of the rubber stopper will decrease accordingly. During the process, the probability of putting the rubber stopper on is reduced. On the other hand, if the drug is not properly punctured during clinical use, the rubber stopper can easily be inserted into the bottle.

As far as the performance of the rubber stopper is concerned, the hardness is an important control item that cannot be ignored. If the hardness of the rubber stopper is too low, the rubber stopper is easily deformed by the internal pressure during steam sterilization in the pharmaceutical factory, and the chance of sealing is reduced during use, which affects production efficiency and The sterility of the product is guaranteed. In addition, when the injection needle is inserted into the rubber stopper in clinical use, the rubber stopper is also easy to be pushed into the bottle; if the hardness is too high, a lot of force is required when the injection needle is inserted, which is not easy to operate, and at the same time, the puncture debris will also be obvious increase, and will reduce the airtight self-sealing performance of the rubber plug

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