WO2017167175A1

WO2017167175A1 - Membrane-coated rubber plug and method for producing same

Info

Publication number: WO2017167175A1
Application number: PCT/CN2017/078409
Authority: WO
Inventors: 华国平; 华一敏; 华智敏
Original assignee: 江苏华兰药用新材料股份有限公司
Priority date: 2016-03-29
Filing date: 2017-03-28
Publication date: 2017-10-05
Also published as: CN105662859A; JP3222491U

Abstract

Provided is a membrane-coated rubber plug, comprising a rubber-plug top part (1) and a rubber-plug neck part (2); the bottom surface of the rubber-plug neck part (2) is a spherical arcuate surface; the surface of the rubber-plug neck part (2) is covered with a membrane (4); the membrane-coated part extends from the surface of the rubber-plug neck part (2) to the position of the plane of the seal between the rubber-plug top part (1) and the bottle mouth; the plug support (3) of the rubber-plug neck part (2) is smaller at the top and larger at the bottom; the top surface of the rubber-plug top part (1) is provided with a spherical concave-surface needlestick hole (5), and a projecting part (6) is disposed around the needlestick hole (5); the method for producing the described membrane-coated rubber plug comprises four steps: extrusion, punching, vulcanization, and post-treatment.

Description

Plastic coated rubber plug and production method thereof

Technical field

The invention relates to a plastic film plug and a production method thereof, which are mainly used for encapsulation and sealing of an injection medicine.

technical background

In the existing rubber plug for sealing and sealing of the injection medicine, if the medicine is inverted, the penetration and precipitation of the medicine may affect the safety of the medicine; if the water needle medicine directly contacts the rubber stopper, it will produce "infiltration" and " Substances such as dissolution, precipitation, leaching, and extractability lead to a reduction in the safety of the drug; existing rubber plugs for sealing and sealing of injection drugs can cause needle-punching and chipping when used in clinical practice using non-standard needles. Exceeding the standard; the existing rubber plug production process must ensure silicidation of the rubber plug in order to ensure the stability during high-speed dispensing. Silicone oil will cause pollution to the drug and affect the safety of the drug; the traditional medical rubber plug production process needs twice. Vulcanization causes environmental pollution.

Summary of the invention

In order to overcome the deficiencies of the prior art, the present invention aims to disclose a plastic film plug and a production method thereof to solve the problems of infiltration, precipitation and sealing of the existing rubber plug when sealing the sealing agent; The direct contact of the plug affects the safety of the drug, the clinical use of non-standard needle acupuncture and falling debris exceeds the standard, affects the safety of the drug, the contamination of the drug by the silicone oil, the safety of the drug, and the environmental pollution caused by the secondary vulcanization in the production process.

In order to achieve the above object, the present invention provides the following technical solutions:

The coated rubber plug comprises a rubber plug crown (1) and a rubber plug neck (2), wherein the bottom surface of the rubber plug neck (2) is a spherical arc surface, and the rubber plug neck (2) The surface is covered with a film (4), and the film covering portion extends from the surface of the rubber plug neck (2) to a plane position where the crown portion and the bottle mouth are sealed.

In the above-mentioned coated rubber stopper, the coating portion extends from the surface of the rubber stopper neck (2) to the one-fifth of the plane where the crown portion is sealed with the bottle mouth.

In the above-mentioned coated rubber plug, the plug portion (3) of the rubber plug neck (2) is small on the upper surface and large on the lower surface.

In the foregoing plastic film plug, the top surface of the rubber plug crown (1) is provided with a spherical concave needle hole (5).

In the above-mentioned coated rubber stopper, the top surface of the rubber stopper crown (1) is provided with a symmetrical protruding portion (6).

In the foregoing coated rubber plug, the protruding portion (6) is a circular ring surrounding the needled hole (5).

The foregoing method for producing a coated rubber plug is carried out according to the following steps:

Step one, squeeze

Extruding the compounded rubber into a rubber sheet using an extruder;

Step two, punching

Put the rubber sheet extruded in step one on the film, press-fit, and then press the rubber sheet pressed with the film together on the die to form a piece of round-coated rubber disc;

Step three, vulcanization

The circular coated rubber disc prepared in the second step is placed in the cavity of the mold, the surface of the coating is below, and then a layer of rubber is placed on the circular coated rubber disc according to the weight of the rubber plug, and then Vulcanization, that is, a film rubber plug;

Step 4, post processing

The three-vulcanized film rubber plug is punched and cleaned.

The invention adopts the above technical solution, and the coating part of the plastic film plug adopts a spherical arc surface design to ensure uniformity of film extension, uniformity of thickness and uniformity of shielding of the drug, and ensure safety of the preparation; The plug portion of the neck position is small on the top, and the large design below prevents the rubber plug from jumping during the continuous dispensing process; the surface of the rubber plug neck is covered with a film, and the film covering portion extends from the plug neck to the crown The position of one-fifth of the plane sealed with the bottle mouth, the design of the film and the combination of the film-covered parts can realize that the medicine will not penetrate, precipitate, and dissolve, so that the medicine is sealed and the medicine is prevented from being leaked due to poor sealing; The spherical concave needle hole provided on the surface of the rubber plug can effectively reduce the puncture force and prevent the needle-dropping debris from exceeding the standard caused by the use of the non-standard needle. The spherical concave surface design makes the rubber plug crown not have a right angle or a dead angle, and the rubber plug is easy to clean. The nurse is convenient and safe to disinfect before using the preparation; the structure is provided on the surface of the rubber plug, so that the rubber stopper does not stick at high speed, ensuring stability at high speed dispensing. Acupuncture hole out of the ring projection design, not only to prevent the adhesion of the rubber plug, rubber plug is also beneficial to take the suction plug stable machine. One-time forming rubber plug does not need secondary high temperature vulcanization in the production process, does not use silicidation process, does not use any chemical adhesive, no secondary pollution of materials, no change in physical properties of rubber compound and film, no product Any crack, no micropores, no Any aging ensures the original properties of the film.

DRAWINGS

Figure 1 is a top view of the film rubber plug;

Figure 2 is a schematic view showing the structure of a rubber plug;

Figure 3 is a schematic cross-sectional view of the film rubber plug and the bottle.

detailed description

The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

Embodiment 1: FIG. 1 is a top view of a rubberized plug, FIG. 2 is a schematic structural view of a laminated rubber plug, and FIG. 3 is a schematic cross-sectional view of a plastic plug and a bottle, and the rubber plug includes a rubber plug crown (1) And the rubber plug neck (2), the rubber plug neck (2) adopts a spherical arc surface design, the plug portion (3) of the rubber plug neck (2) is small on the top, the bottom is large, and the rubber plug is necked. The bottom surface of the part (2) is a spherical arc surface, and the coating part of the plastic film plug adopts a spherical arc surface design to ensure the uniformity of the film, uniformity of thickness, uniformity of shielding of the drug, ensuring the safety of the preparation, and the plug. Part (3) The upper and lower design ensures that the high-speed dispensing will stop the plug, improve the stability, and prevent the secondary pollution caused by the plugging during the dispensing; the surface of the plug neck (2) is covered with a film (4) The filming portion extends from the surface of the plug neck to one-fifth of the plane position of the crown portion and the mouth seal, and the design of the film and the position of the film extend to the plane of the crown portion and the mouth of the bottle seal. One-fifth of the place can not only prevent the direct contact between the injection drug and the gel plug, but also ensure that the drug is not inverted. Exudation and precipitation appear to protect the safety of the medicine; the top surface of the rubber stopper plug (1) is provided with a spherical concave needle hole (5), adopting a spherical concave surface design, reducing the puncture force, and being effective Preventing the use of non-standard needles to puncture and falling off the mark, the spherical concave design makes the rubber plug crown not leave a right angle, dead angle, the rubber plug is easy to clean, the nurse is convenient and safe to disinfect before using the preparation; around the acupuncture hole (5) The plane is provided with a symmetrical protruding portion (6). This design not only eliminates the silicidation process, but also ensures that the rubber plug does not have any resistance during dispensing, and also prevents the unqualified injection of the silicone oil during the silicidation process. .

Embodiment 2: FIG. 1 is a top view of a rubberized plug, FIG. 2 is a schematic structural view of a laminated rubber plug, and FIG. 3 is a schematic cross-sectional view of a laminated rubber plug and a packaging bottle, and can also be wrapped around a plastic plug. The puncture hole (5) is provided with a ring protrusion. The ring protrusion is higher than the rubber plug plane, which not only prevents the rubber plug from sticking, but also facilitates the rubber stopper. The suction plug is stable.

The method for producing the film rubber plug of the present invention has the following steps:

Step one, squeeze

Extruding the compounded rubber into a rubber sheet using an extruder;

Step two, punching

Step three, vulcanization

Step 4, post processing

The three-vulcanized film rubber plug is punched and cleaned.

The above-mentioned production method of the molded film rubber plug does not require secondary high temperature vulcanization in the production process, does not use the silicidation process, does not use any chemical adhesive, has no secondary pollution of the material, and has no physical properties of the rubber compound and the film. Any change, the product does not have any cracks, no micropores, no aging, to ensure the original characteristics of the film.

Other than the above-described embodiments, the present invention may have other embodiments. Any technical solution formed by equivalent replacement or equivalent transformation falls within the protection scope of the present invention.

Claims

A plastic film plug comprising a rubber plug crown (1) and a rubber plug neck (2), characterized in that the bottom surface of the rubber plug neck (2) is a spherical arc surface, and the rubber plug neck (2) The surface is covered with a film (4) extending from the surface of the rubber plug neck (2) to a plane position where the crown portion and the bottle mouth are sealed.
A coated rubber stopper according to claim 1, wherein said coating portion extends from the surface of the rubber stopper neck (2) to a position one fifth of the surface of the crown and the mouth of the bottle.
A coated rubber stopper according to claim 1, characterized in that the plug portion (3) of the rubber plug neck (2) is small on the upper surface and large on the lower surface.
A coated rubber stopper according to claim 1, characterized in that the top surface of the rubber stopper crown (1) is provided with a spherical concave needle hole (5).
A film-coated rubber stopper according to claim 1, characterized in that said top surface of the rubber stopper crown (1) is provided with a symmetrical projection portion (6).
A film-coated rubber stopper according to claims 1 and 5, characterized in that said protruding portion (6) is a circular ring surrounding the needle-punching hole (5).
A method of producing a coated rubber plug according to claim 1, wherein the method is as follows:

Step one, squeeze

Extruding the compounded rubber into a rubber sheet using an extruder;

Step two, punching

Put the rubber sheet extruded in step one on the film, press-fit, and then press the rubber sheet pressed with the film together on the die to form a piece of round-coated rubber disc;

Step three, vulcanization

The circular coated rubber disc prepared in the second step is placed in the cavity of the mold, the surface of the coating is below, and then a layer of rubber is placed on the circular coated rubber disc according to the weight of the rubber plug, and then Vulcanization, that is, a film rubber plug;

Step 4, post processing

The three-vulcanized film rubber plug is punched and cleaned.