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Medical halogenated butyl rubber stopper production method

A technology of halogenated butyl rubber and production method, which is applied in the production field of neutral salt extraction treatment of pharmaceutical halogenated butyl rubber stoppers, which can solve the problems of environmental pollution, corrosion of equipment, cumbersome manufacturing process, etc., and achieve simple process , The effect of small corrosion of equipment

Active Publication Date: 2013-08-07
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

At present, there are two ways to reduce the influence of extractables and leachables in halogenated butyl rubber stoppers on drug compatibility: one is the barrier method, which is to coat the surface of halogenated butyl rubber stoppers with a patent application number of 200510021897.7 And patent application No. 201110039764.8 discloses such a technology, but its manufacturing process is relatively cumbersome, and there are problems of sealing and puncture debris; The extractables and leachables are extracted to reduce the extractables and leachables in the halogenated butyl rubber stoppers to meet the compatibility requirements of the halogenated butyl rubber stoppers and drugs
At present, acid-base extraction is also used to achieve this purpose, but acid-base will corrode the equipment, pollute the environment and cannot be recycled and reused.

Method used

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  • Medical halogenated butyl rubber stopper production method
  • Medical halogenated butyl rubber stopper production method
  • Medical halogenated butyl rubber stopper production method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1: A production method of pharmaceutical halogenated butyl rubber stoppers. A certain amount of halogenated butyl rubber stoppers is immersed in an aqueous solution of sodium chloride with a concentration of 3% by mass and treated at 120° C. for 60 minutes.

[0021] The halogenated butyl rubber stopper treated with the aqueous solution of sodium chloride was rinsed with water for injection and siliconized with 350 cst of medical grade simethicone.

[0022] The above-mentioned siliconized halogenated butyl rubber stopper was dried at 120° C. for 60 minutes to obtain a pharmaceutical halogenated butyl rubber stopper that could meet the requirements. The results of the compatibility test between the obtained pharmaceutical halobutyl rubber stopper and ceftriaxone sodium for injection are shown in Table 1.

[0023] Table 1

[0024]

Embodiment 2

[0025] Embodiment 2: A kind of production method of medicinal halogenated butyl rubber stopper, a certain amount of halogenated butyl rubber stopper is immersed in the mixed aqueous solution of sodium chloride and acetic acid (the mass percent concentration of sodium chloride in the mixed aqueous solution is 3% , the concentration of acetic acid in the mixed aqueous solution is 0.01% by mass) at 120°C for 60 minutes.

[0026] The halogenated butyl rubber stopper treated with the mixed aqueous solution of sodium chloride and acetic acid was rinsed with water for injection and siliconized with 350 cst medical grade simethicone.

[0027] The above-mentioned siliconized halogenated butyl rubber stopper was dried at 120° C. for 60 minutes to obtain a pharmaceutical halogenated butyl rubber stopper that could meet the requirements. The results of the compatibility test between the obtained pharmaceutical halobutyl rubber stopper and cefotaxime sodium for injection are shown in Table...

Embodiment 3

[0030] Embodiment 3: A kind of production method of medicinal halogenated butyl rubber stopper, put a certain amount of halogenated butyl rubber stopper in the mixed aqueous solution of potassium chloride and acetic acid (the mass percent concentration of potassium chloride in the mixed aqueous solution is 1% , the concentration of acetic acid in the mixed aqueous solution is 0.01% by mass) at 120°C for 60 minutes.

[0031] The halogenated butyl rubber stopper treated with the mixed solution of potassium chloride and acetic acid was rinsed with water for injection and siliconized with 1000 cst of medical grade simethicone.

[0032] The above-mentioned siliconized halogenated butyl rubber stopper was dried at 120° C. for 60 minutes to obtain a pharmaceutical halogenated butyl rubber stopper that could meet the requirements. The results of the compatibility test between the obtained pharmaceutical halobutyl rubber stopper and cefoperazone sodium sulbactam sodium for injection ar...

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Abstract

The invention provides a medical halogenated butyl rubber stopper production method. The method comprises the following steps: firstly, soaking the halogenated butyl rubber stopper into an extraction medium to treat; rinsing the halogenated butyl rubber stopper treated by the extraction medium through utilizing purified water or injection water, and then adding silicone oil for siliconizing; and drying the siliconized halogenated butyl rubber stopper at 100-130 DEG C, thus obtaining the medical halogenated butyl rubber stopper which can satisfy requirements. The neutral salt aqueous solution used by the method slightly corrodes equipment, is pollution-free and can be recycled, and the method is an energy-saving and environmental-friendly method. The medical halogenated butyl rubber stopper produced by using the method can satisfy special medicine compatibility requirements.

Description

technical field [0001] The invention relates to a production method of a medicinal rubber stopper, in particular to a production method of a medicinal halogenated butyl rubber stopper by neutral salt extraction treatment. Background technique [0002] Pharmaceutical halogenated butyl rubber stoppers are mainly produced from bromobutyl rubber or chlorinated butyl rubber as the main material. At present, the pharmaceutical halogenated butyl rubber stoppers produced in China can meet the requirements of some conventional insensitive drugs, but they cannot meet the requirements of some drugs with strong molecular activity. The most prominent are some cephalosporins, some Therapeutic drugs and some traditional Chinese medicine injection preparations, etc. The main reason is that due to the complex formula of the halogenated butyl rubber stopper and the concentration gradient of the added raw materials, after encapsulation with some drugs with strong molecular activity, the extra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08J7/12C08L15/00
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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