Coated drug bottle plug and manufacturing method thereof

Abstract

The invention discloses a new type coated drug bottle plug and a manufacturing method thereof, comprising a plug crown and a plug neck, wherein a sealing face between a bottle plug crown part and a plug port as well as a plug neck part are respectively provided with a coating layer. The method for manufacturing the coated drug bottle plug is as follows: 1) with adoption of a routine process, vulcanizing and forming integrated rubber sheets which are connected with plural bottle plugs via film partition sides through a bottle plug mould; 2) covering and sealing the plug crown face part of the single integrated rubber sheet or that of two integrated rubber sheets which are correspondingly clung and fixed with each other as a whole with shielding barriers; 3) coating the integrated rubber sheets which are covered and sealed as a whole; 4) removing the shielding barriers from the plug crown face parts; and 5) annularly punching the integrated rubber sheets which are coated at punching points to obtain a finished product of the new type coated drug bottle plug. Compared with the existing bottle plug, the drug bottle plug produced by the invention is of better drug compatibility.

Description

technical field [0001] The invention relates to a drug bottle stopper in the technical field of medical packaging materials, which is a partially coated drug bottle [0002] Stopper, especially a novel coating drug bottle stopper and its manufacturing method. Background technique [0003] As we all know, the medicinal bottle stopper is an elastomeric packaging material that is in direct contact with the drug, and will interact with the drug, resulting in poor stability of the drug. The compatibility of bottle stoppers and medicines seriously affects the quality of medicines and brings potential safety hazards to patients. In order to solve the problem of compatibility between the bottle stopper and the drug, the technologies currently used include: one is to cover the neck part of the bottle stopper with the direct contact with the drug with polytetrafluoroethylene film; The deposition technique coats the entire surface of the cork with a layer of parylene material. The ...

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Problems solved by technology

This process has the following disadvantages: 1) Secondary molding process is required, the process is complicated, and the production efficiency is low; and because of the limited ductility of the PTFE film, the possibility of film rupture is extremely high, which affects the reliability of use. Poor quality; 2) It is only suitable for bottle stoppers with relatively simple structural shapes. For complex shapes, the manufacturing cost is high and the product yield is extremely low; 3) Since the protective film layer is only on the stopper neck, the drug will still penetrate into the non-coated cork The sealing surface of the cork crown and the bottle mouth, for infusion preparations with strong extractability of sodium bicarbonate, a small amount of contact with the rubber stopper is enough to cause the drug to be unqualified, and there are hidden dangers in the safety and reliability of the drug

Although the second method better solves the compatibility problem of medicines and avoids the use of silicone oil, it still has the following disadvantages: the coating layer completely covers the bottle stopper, resulting in less elastic deformation of the bottle stopper during use, and it is easy to get stuck between the cork crown and the bottle stopper. Leakage is formed at the sealing joint of the bottle mouth, which leads to poor sealing performance of the bottle stopper on the medicine, and affects safety and reliability

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