Synthetic polyisoprene rubber plug for injection and preparation method thereof

A technology of polyisoprene rubber stopper and polyisoprene, which is applied in the direction of hypodermic injection devices, etc., can solve problems such as poor resilience, leakage of liquid when pulling out needles, waste of labor and energy consumption, etc., and achieve good elasticity, Stable performance and good sealing effect

Inactive Publication Date: 2012-10-03
QINGDAO HUAREN MEDICAL PROD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The above two rubber plug materials have certain deficiencies and cannot fully meet the needs of use, specifically:
[0004] First: The butyl rubber stopper has good chemical stability, but it is easy to produce debris when punctured, has poor resilience, and is prone to needle withdrawal and leakage, which leads to complaints from hospital medical staff and patients;
[0005] Second, the isoprene rubber gasket has good resilience, sealing and puncture and chip resistance, but the chemical properties of the isoprene rubber in the current product cannot meet the quality standards for rubber plugs used in direct contact with drugs and biological Index standard, so it can only be used as a gasket. It must be used with a polypropylene inner cover and an outer cover in the form of a combined cover, resulting in many accessories, complex structures, cumbersome processes, and a large waste of labor and energy costs;
[0006] Third, in the research on isoprene rubber formulation technology, most of them use substances containing sulfur, zinc oxide or thiuram accelerators. Such substances can be converted into nitrosamines, which are limited substances. The quality assurance of medicines has potential safety hazards

Method used

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  • Synthetic polyisoprene rubber plug for injection and preparation method thereof

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preparation example Construction

[0040] Specifically, the preparation method of the above-mentioned synthetic polyisoprene rubber stopper for injection comprises the following steps:

[0041] a. Weighing and banburying: Weigh the raw materials, put the weighed isoprene rubber in the internal mixer, first carry out half-pressure mastication, and then carry out full-pressure mastication, and then add stearic acid, titanium dioxide and carbon Black for rubber mixing, then add clay and white carbon black for rubber mixing and sweeping, continue rubber mixing after sweeping, and discharge after rubber mixing. Specifically include: turn on the internal mixer to heat up, when the temperature of the internal mixing chamber rises to 38°C ± 1°C, put in isoprene rubber, first half-pressure masticate for 30 seconds ± 5 seconds, then full-pressure masticate for 60 seconds ± 5 seconds; add stearic acid, titanium dioxide and carbon black, and mix the rubber for 90 seconds ± 5 seconds; add clay and white carbon black, mix th...

Embodiment 1

[0052] Weigh 61.24% of isoprene rubber, 24.49% of clay, 0.55% of stearic acid, 7.35% of white carbon black, 5.42% of titanium dioxide, 0.24% of carbon black and 0.61% of peroxide curing agent, Preparation of synthetic polyisoprene rubber stopper products.

[0053] The specific process is as follows:

[0054] a1. Weighing and internal mixing: Weigh the raw materials, turn on the internal mixer to heat up, and when the temperature of the internal mixing room rises to 38°C, put in isoprene rubber, first half-pressure masticating for 30 seconds, and then full-pressure masticating 60 seconds; add stearic acid, titanium dioxide and carbon black, and mix the rubber for 90 seconds; add clay and white carbon black, and sweep the rubber after 60 seconds of rubber mixing; after sweeping, continue to mix the rubber for 60 seconds; open the internal mixer room Discharge the mixed rubber, and the discharge temperature is about 40°C;

[0055] b1. Opening and extruding: Turn on the open mix...

Embodiment 2

[0063] Weigh 70% of isoprene rubber, 20% of clay, 0.4% of stearic acid, 7% of white carbon black, 1.9% of titanium dioxide, 0.2% of carbon black and 0.5% of peroxide curing agent, Preparation of synthetic polyisoprene rubber stopper products.

[0064] The specific process is as follows:

[0065] a1. Weighing and internal mixing: Weigh the raw materials, turn on the internal mixer to heat up, and when the temperature of the internal mixing room rises to 39°C, put in isoprene rubber, first half-pressure masticating for 35 seconds, and then full-pressure masticating 65 seconds; add stearic acid, titanium dioxide and carbon black, and mix the rubber for 95 seconds; add clay and white carbon black, and sweep the rubber after 65 seconds of rubber mixing; after sweeping, continue to mix the rubber for 65 seconds; open the internal mixer room Discharge the mixed rubber, and the discharge temperature is about 43°C;

[0066] b1. Opening and extruding: Turn on the open mixer to heat up...

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PUM

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Abstract

The invention relates to a synthetic polyisoprene rubber plug for an injection and a preparation method thereof. The synthetic polyisoprene rubber plug for the injection comprises the flowing components in percentage by weight: 61.24-76.22 percent of isoprene rubber, 15.24-24.49 percent of pottery clay, 0.30-0.55 percent of stearic acid, 6.1-7.35 percent of white carbon black, 1.52-5.42 percent of titanium dioxide, 0.15-0.24 percent of carbon black and 0.46-0.61 percent of peroxide vulcanizing agent. According to the synthetic polyisoprene rubber plug disclosed by the invention, due to the adoption of a peroxide vulcanizing system, an isoprene rubber product is prepared from a raw material without sulfur; the final rubber plug product cannot generate a sulfur-containing substance; and the produced isoprene rubber product can be directly contacted with medicines for use and has the advantages of stable performance, puncture resistance, no falling scraps, favorable elasticity, no needle extracting leaked liquid, favorable sealing property and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical packaging materials, in particular to a synthetic polyisoprene rubber stopper for injection and a preparation method thereof. Background technique [0002] At present, in the field of rubber stoppers in pharmaceutical packaging materials, one of the rubber stoppers that need to directly contact drugs uses butyl rubber stoppers, that is, the main material in the rubber stopper formula --- rubber, which is halogenated butyl rubber; Another kind of rubber stopper that does not directly contact the drug uses a pharmaceutical synthetic polyisoprene gasket, that is, the main material in the formula-rubber, is isoprene rubber, specifically, the rubber gasket is combined with polypropylene It is used as a seal in the combination cap, and the polypropylene inner cap of the combination cap is in direct contact with the drug. [0003] The above two rubber plug materials have certain deficiencies and ...

Claims

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Application Information

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IPC IPC(8): C08L9/00C08K13/02C08K3/34C08K3/36C08K3/22C08K5/09C08K3/04C08K5/01B29C43/24B29C35/00B29B7/00A61M5/315
Inventor 肖维文闫宝英
Owner QINGDAO HUAREN MEDICAL PROD
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