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Compound film rubber cork and its preparation method

A technology of rubber stoppers and rubber stoppers, applied in the field of compound film rubber stoppers and their preparation, can solve the problems of harming patients, poor airtightness, easy moisture absorption and mildew, etc., to save equipment and costs, avoid direct contact, and facilitate industrialization Effect

Inactive Publication Date: 2008-07-02
刘永红
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The reason why natural rubber plugs have been completely eliminated is because of the following disadvantages: 1. Poor biological safety, easy to absorb moisture and become moldy; 2. The heterosexual protein dissolved from natural rubber plugs is one of the important factors that lead to human heat sources; 3. The dissolved pyridine compounds are easy to cause cancer, teratogenicity and mutagenesis; 4. The chemical properties are relatively active and easy to interact with drugs; 5. The air tightness is poor; it has a high diffusion rate for various gases; 6. , During sterilization, a large number of harmful residual chemical accelerators, vulcanizing agents, heavy metals in auxiliary materials, proteins and other substances migrate concentratedly into the gap above the plug diameter and the cushion membrane, and directly enter the blood vessel and vein after puncture. consciously endanger the patient
Since the safety certification of polyfluorinated materials has not been obtained in my country, polyfluorinated materials have not been approved as inner packaging materials that directly contact drugs, and the tensile testing machine (Shanghai Chemical Machinery No. 4 Factory, XLL-2500N) used to measure Elongation rate The rate of change in elongation is only 5.5%. If the damage rate of the laminated rubber stopper prepared by this method is high
In addition, the process of using plasma technology to treat the surface of the membrane is complicated and the cost is relatively high, which is not conducive to industrialization

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Preparation of the composite rubber stopper of the present invention

[0024] Tightly cover the polypropylene film and the unvulcanized natural rubber sheet for infusion on the mold of the vacuum vulcanizing machine. In the mold, press 15-20 Pa at a temperature of 160°C to make a rubber stopper shape. The film is pressed tightly on the rubber. Plug the bottom surface. Trim off the edges.

Embodiment 2

[0025] Example 2 Preparation of the composite rubber stopper of the present invention

[0026] Tightly cover the polyethylene film and the unvulcanized powder needle with a natural rubber sheet on the mold of the vacuum vulcanizing machine. In the mold, press 15-20 Pa at a temperature of 120 ℃, and then evacuated to form a rubber stopper shape. The bottom of the rubber stopper. Trim off the edges.

Embodiment 3

[0027] Example 3 Preparation of the composite rubber stopper of the present invention

[0028] The polyester film and the unvulcanized polyisoprene film are tightly covered on the mold of the vacuum vulcanizing machine. In the mold, press 15-20 Pa at a temperature of 110 ℃, and then vacuumize to form a rubber plug shape. The film is pressed tightly on the mold. The bottom of the rubber stopper. Trim off the edges.

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PUM

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Abstract

A film covered rubber plug is composed of a rubber plug and a covering high-molecular film chosen from polyethene, polypropene, polyester and polystyrene. Said film has a fusion point close to that of rubber and is directly and physically adhered onto surface of rubber plug without adhesive.

Description

Technical field [0001] The invention relates to a medicinal rubber stopper and a preparation method thereof, in particular to a composite rubber stopper and a preparation method thereof. Background technique [0002] The State Food and Drug Administration document No. 462 stipulates that from January 1, 2005, all pharmaceutical packaging bottles will stop using natural rubber stoppers and use butyl rubber stoppers or coated or laminated rubber stoppers. Natural rubber stoppers have been completely eliminated because of the following shortcomings: 1. Poor biological safety, easy to absorb moisture and mold; 2. The foreign protein eluted from natural rubber stoppers is one of the important factors that cause human body heat; 3. The dissolved pyridine compounds are easily carcinogenic, teratogenic, and mutagenic; 4. The chemical properties are relatively active and easy to interact with drugs; 5. The air tightness is poor; it has a high diffusion rate for various gases; 6 During ste...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): B65D39/18A61J1/14B29C35/02B29K23/00B29K67/00B29K27/18
Inventor 刘永红
Owner 刘永红