New type 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 involves a pharmaceutical bottle plug in the field of pharmaceutical packaging materials, which is a local coating drug bottle [0002] Plug, especially a new type of coating drugs and its manufacturing methods. Background technique [0003] As we all know, medicinal bottle plugs are elastic packaging materials that are directly in contact with drugs, which will occur with the drug, resulting in poor pharmaceutical stability.The compatibility problem of bottle plugs and drugs seriously affects the quality of the medicine and brings potential drug safety hazards to patients.In order to solve the compatibility of bottle plugs and medicines, the current technologies adopted include: one is to cover polytetrafluoroethylene membrane in the plug neck part of the plug and medicine;The sedimentation technology is plated on the entire surface of the bottle plug.Through the covering membrane layer to form resistance to the plug, the possible impact on t...

AI Technical Summary

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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