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Preparation method of medical rubber stopper

A production method and technology of rubber stoppers, which are applied in the field of production of high-performance medical halogenated butyl rubber stoppers, can solve the problems of cumbersome manufacturing process, complex formula, and compatibility, and meet the requirements of special drug compatibility, The effect of simple process

Active Publication Date: 2013-08-14
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

However, due to the complex formula and the concentration gradient of the added raw materials, after being encapsulated with some drugs with relatively strong molecular activity, they are absorbed, adsorbed, leached, and infiltrated by the drugs, resulting in compatibility problems between the rubber plug and the drug. The most prominent is Some cephalosporins, some therapeutic drugs, and some traditional Chinese medicine injection preparations, etc.
Patent application number 200510021897.7 and patent application number 201110039764.8 disclose a film-coated or coated rubber stopper and its manufacturing method. The disclosed manufacturing process is relatively cumbersome, and there are problems of airtightness and puncture debris

Method used

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  • Preparation method of medical rubber stopper
  • Preparation method of medical rubber stopper
  • Preparation method of medical rubber stopper

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Embodiment 1: A kind of production method of medical rubber stopper, the rubber stopper is immersed in the alkaline aqueous solution for treatment; The rubber stopper treated in the alkaline aqueous solution is immersed in the acidic aqueous solution for neutralization treatment; The acidic aqueous solution is neutralized Rinse the rubber stopper with purified water or water for injection, and add silicon oil for siliconization treatment; dry the siliconized rubber stopper at 115~130°C to obtain a medical rubber stopper that can meet the compatibility requirements of special drugs.

[0012] The alkaline aqueous solution is sodium hydroxide or sodium carbonate with a concentration of 0.05-3% by mass; the temperature for immersion in the alkaline aqueous solution is 110-140° C., and the time is 30-90 minutes. The acidic aqueous solution is an aqueous solution of hydrochloric acid solution with a mass percentage concentration of 0.05 to 0.25% and a 0.1% mass percentage conc...

Embodiment 2

[0014] Example 2: A production method of medical rubber stoppers. A certain amount of halogenated butyl rubber stoppers is treated in sodium hydroxide (NaOH) with a concentration of 0.20% by mass at 121° C. for 60 minutes.

[0015] The above-mentioned rubber stopper treated with an alkaline aqueous solution is mixed with a hydrochloric acid solution of 0.20% by mass percentage concentration and an aqueous solution of disodium edetate with a concentration of 0.2% by mass percentage, hydrochloric acid solution and disodium edetate in the aqueous solution The volume ratio of the aqueous solution is 1:0.05, and it is treated at 50°C for 10 minutes.

[0016] The rubber stopper treated with the acidic aqueous solution was rinsed with water for injection and siliconized with 350 cst of simethicone.

[0017] The siliconized rubber stopper was dried at 115° C. for 60 minutes. The compatibility test results of the obtained high-performance medical rubber stopper and ceftriaxone sodium ...

Embodiment 3

[0020] Embodiment 3: A production method of medical rubber stoppers, treating halogenated butyl rubber stoppers in sodium hydroxide (NaOH) with a concentration of 0.20% by mass at 121° C. for 60 minutes.

[0021] The above-mentioned rubber stopper treated with an alkaline aqueous solution is mixed with an aqueous solution of 3% phosphoric acid and a 0.1% aqueous solution of disodium edetate in a concentration of 3% by mass, phosphoric acid solution and disodium edetate in the aqueous solution The volume ratio of the aqueous solution is 1:0.05, and it is treated at 50°C for 10 minutes.

[0022] The rubber stopper treated with the acidic aqueous solution was rinsed with water for injection and siliconized with 500 cst of simethicone.

[0023] The siliconized rubber stopper was dried at 115° C. for 60 minutes. The compatibility test results of the obtained high-performance medical rubber stopper and ceftriaxone sodium for injection are shown in Table 2.

[0024] Table 2

[002...

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Abstract

The invention relates to a preparation method of a medical rubber stopper, which comprises the steps as follows: a rubber stopper is immersed into alkaline aqueous solution; the rubber stopper treated with the alkaline aqueous solution is immersed into acid aqueous solution for neutralization; the rubber stopper neutralized with the acid aqueous solution is rinsed with purified water or water forinjection and siliconized with silicone oil; the siliconized rubber stopper is dried at 115-130 DEG C; and the medical rubber stopper meeting the requirement of compatibility of particular drugs is obtained. The preparation method of the medical rubber stopper has simple process and realizes industrialization easily. High-performance medical rubber stoppers treated by the method do not affect thesealing performance of the original halogenated butyl rubber stopper, and can meet the requirements of Standard YBB00042005 and / or Standard YBB00052005 issued by the State Food and Drug Administration and the requirement of compatibility of particular drugs.

Description

technical field [0001] The invention relates to a production method of a medical rubber stopper, in particular to a production method of a high-performance medical halogenated butyl rubber stopper which can meet the compatibility requirements of special medicines. Background technique [0002] At present, medical rubber stoppers are mainly produced from halogenated butyl rubber. Halogenated butyl rubber, including chlorobutyl rubber and brominated butyl rubber, contains about 97-99% isobutylene and 1-3% isoprene in its molecular structure, and 1.8-2.2% chlorine in its molecular structure atom or bromine atom. When selecting a vulcanizing agent, the double bonds and halogen atoms in the molecular structure of chlorobutyl rubber and bromobutyl rubber are usually used for crosslinking. The types of vulcanizing agents commonly used include zinc oxide, sulfur, sulfur donors, alkanes, etc. Based on phenolic resin, magnesium oxide, amine compounds, etc., using this rubber and mat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08J7/12C08L23/28
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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