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Vulcanizing system and medical chlorinated butyl rubber plug

A chlorinated butyl rubber and vulcanizing agent technology, which is applied in the directions of medical containers, medical packaging, packaging items, etc., can solve the problems of tight puncture and chipping, cumbersome manufacturing process, pollution of molds, etc., and achieves easy availability of raw materials and simple process. Effect

Active Publication Date: 2014-04-16
郑州翱翔医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to solve the compatibility problem of these medicines, patent application No. 200510021897.7 and patent application No. 201110039764.8 disclose a film-coated or coated rubber stopper and its manufacturing method. The disclosed manufacturing process is relatively cumbersome, and there are The problem of airtightness and puncture debris, the patent application number is 200710135267.1 discloses a chlorinated butyl rubber stopper for injection and its production method. The mold is serious, and it only involves a chlorobutyl rubber stopper for injection, not a chlorobutyl rubber stopper for cephalosporin powder drugs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1: A medical chlorinated butyl rubber stopper, prepared from the following raw materials in parts by weight: 100 parts of chlorinated butyl rubber (CIIR1066), 60 parts of calcined kaolin, γ-mercaptopropyltrimethoxy 4 parts of silane, 1.5 parts of 2-mercaptobenzimidazole, 5 parts of magnesium oxide, 4 parts of titanium dioxide, and 0.6 part of carbon black.

[0021] Its preparation method includes rubber mixing, vulcanization, punching, cleaning, and drying. The rubber mixing adopts a powerful pressurized internal mixer to mix the raw materials evenly, and the mixed rubber is stripped on the open-milling equipment, and the final discharge of the internal mixing is carried out. The temperature is 85°C-95°C, the pressure of the top bolt is 0.6-0.8Mpa, and the mixing cycle is 13-15 minutes; the vulcanization adopts the injection vulcanization molding process, the vulcanization temperature is 185°C, the vulcanization pressure is 240bar, and the vulcanization clamping ...

Embodiment 2

[0028] Example 2: A medical chlorinated butyl rubber stopper, prepared from the following raw materials in parts by weight: 100 parts of chlorinated butyl rubber (CIIR1066), 40 parts of calcined kaolin, 20 parts of modified talcum powder, γ - 4 parts of aminopropyltrimethoxysilane, 1.5 parts of 2-mercaptobenzimidazole, 5 parts of zinc oxide, 4 parts of titanium dioxide, and 0.6 part of carbon black.

[0029] Its preparation method includes rubber mixing, vulcanization, punching, cleaning, and drying. Among them, the rubber mixing adopts a strong pressurized internal mixer to mix the raw materials evenly, and the mixed rubber is rolled out on the open mixing equipment, and the final mixing is carried out. The temperature of the material is 85°C-95°C, the pressure of the top bolt is 0.6-0.8Mpa, and the mixing cycle is 13-15 minutes; the vulcanization adopts the injection vulcanization molding process, the vulcanization temperature is 190°C, the vulcanization pressure is 240bar, a...

Embodiment 3

[0033] Example 3: A medical chlorinated butyl rubber stopper, prepared from the following raw materials in parts by weight: 100 parts of chlorinated butyl rubber (CIIR1066), 60 parts of calcined kaolin, γ-mercaptopropyltrimethoxy 5 parts of silane, 1 part of thiol imidazoline, 3 parts of zinc oxide, 4 parts of titanium dioxide, and 0.6 part of carbon black.

[0034] Its preparation method includes rubber mixing, vulcanization, punching, cleaning, and drying. Among them, the rubber mixing adopts a strong pressurized internal mixer to mix the raw materials evenly, and the mixed rubber is rolled out on the open mixing equipment, and the final mixing is carried out. The temperature of the material is 85°C-95°C, the pressure of the top bolt is 0.6-0.8Mpa, and the mixing cycle is 13-15 minutes; the vulcanization adopts the injection vulcanization molding process, the vulcanization temperature is 190°C, the vulcanization pressure is 240bar, and the vulcanization clamping force 400 to...

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Abstract

The invention discloses a vulcanizing system, which consists of the following components in parts by weight: 0.5-5 parts of a vulcanizing agent, 0.1-2 parts of a catalyst and 0.5-6 parts of an activating agent, wherein the vulcanizing agent is a silane coupling agent of which the general formula is shown as Y(CH2)nSiX3; in the formula, Y represents alkyl, vinyl, an epoxy group, amino or sulfydryl, and X represents chloro or alkoxyl; the catalyst is thiolimidazoline or 2-thiolbenzimidazole; and the activating agent is zinc oxide or magnesium oxide. A medical chlorinated butyl rubber plug has the advantages of readily-available raw materials and simple process. The medical chlorinated butyl rubber plug prepared by adopting the vulcanizing system can meet the requirements of standards YBB00042005 and / or YBB00052005 issued by the State Food and Drug Administration, can meet the requirements of the Japanese Pharmacopoeia, can meet the requirement of compatibility of special medicaments simultaneously, and is equivalent to the quality of national and international products of the same type.

Description

technical field [0001] The invention relates to a medical chlorinated butyl rubber stopper, in particular to a vulcanization system for preparing the medical chlorinated butyl rubber stopper. Background technique [0002] At present, medical rubber stoppers are mainly produced by halogenated butyl rubber (including chlorinated butyl rubber and brominated butyl rubber). Common vulcanizing agents for vulcanization include zinc oxide, sulfur, sulfur donors, alkylphenolic resins, etc. Rubber stoppers prepared with these vulcanizing agents can meet the compatibility requirements of some conventional non-sensitive drugs. However, there are relatively many extractable / leachable substances in rubber stoppers prepared by these vulcanizing agents. After encapsulation with some drugs with strong molecular activity, these extractable / leachable substances affect the compatibility of rubber stoppers and drugs. The most prominent are some cephalosporins, some large infusions, and many tra...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08K5/548C08K5/5475C08K5/5425C08K5/37C08K3/22C08L23/28A61J1/00A61J1/14
Inventor 马东风代高峰刘海洪李向阳
Owner 郑州翱翔医药科技股份有限公司
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