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Production method of medicinal rubber plug

A production method and technology for rubber stoppers, which are applied in the production field of medicinal rubber stoppers, can solve the problems of easy infiltration into rubber stoppers, cumbersome manufacturing process, and puncture and chipping due to sealing, and achieve the effect of simple process.

Active Publication Date: 2015-12-02
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

[0005] Patent application number 200510021897.7 and patent application number 201110039764.8 disclose a film-coated or coated rubber stopper and its manufacturing method, but the manufacturing process is relatively cumbersome, and there are problems of airtightness and puncture debris
Patent application number 201310174445.7 discloses a production method of pharmaceutical halogenated butyl rubber stoppers, but the liquid medium is easy to penetrate into the rubber stopper under high temperature and high pressure, which increases the difficulty of removal in the subsequent process

Method used

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  • Production method of medicinal rubber plug
  • Production method of medicinal rubber plug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A production method of a medical rubber stopper, the steps are as follows: put the brominated butyl rubber stopper into a vacuum container with a vacuum degree of -0.09Mpa, and conduct heat treatment at 150°C for 50 minutes; The base rubber stopper is first rinsed with an alkaline aqueous solution with a pH value of 10 for 3 minutes, then rinsed with an acidic aqueous solution with a pH value of 3 for 3 minutes, and finally rinsed with purified water for 3 minutes, and the temperature of the rinse water is 50°C; Then 350cst of medical grade simethicone is siliconized and dried at 105°C for 60 minutes to obtain a medical butyl rubber stopper that meets the requirements.

[0023] The basic ultraviolet absorbance of butyl rubber stoppers before and after vacuum heat treatment was tested by ultraviolet spectrophotometer (the extract solution is an alkaline aqueous solution with a pH value of 12), and the reduction of extractables and leachables in butyl rubber stoppers was e...

Embodiment 2

[0025] A production method of a medical rubber stopper, the steps are as follows: put the chlorinated butyl rubber stopper into a vacuum container with a vacuum degree of -0.08Mpa, and conduct heat treatment at 100°C for 100 minutes; The base rubber stopper is first rinsed with an alkaline aqueous solution with a pH value of 9 for 10 minutes, then rinsed with an acidic aqueous solution with a pH value of 2 for 10 minutes, and finally rinsed with purified water for 10 minutes, and the temperature of the rinse water is 100°C; Then 350cst of medical grade simethicone is siliconized and dried at 105°C for 60 minutes to obtain a medical butyl rubber stopper that meets the requirements.

[0026] The results of the compatibility test between the obtained medicinal butyl rubber stopper and cefotiam for injection are shown in Table 1.

[0027] Table 1 Compatibility test results of medicinal butyl rubber stopper and cefotiam for injection

[0028]

Embodiment 3

[0030] A production method of a medical rubber stopper, the steps are as follows: put the chlorinated butyl rubber stopper into a vacuum container with a vacuum degree of -0.09Mpa, and conduct heat treatment at 125°C for 90 minutes; The base rubber stopper is first rinsed with an alkaline aqueous solution with a pH value of 13 for 50 minutes, then rinsed with an acidic aqueous solution with a pH value of 1 for 50 minutes, and finally rinsed with purified water for 50 minutes, and the temperature of the rinse water is 70°C; Then 350cst of medical grade simethicone is siliconized and dried at 105°C for 60 minutes to obtain a medical butyl rubber stopper that meets the requirements.

[0031] The results of the compatibility test between the obtained medicinal butyl rubber stopper and fosfomycin sodium for injection are shown in Table 2.

[0032] Table 2 Compatibility test results of medicinal butyl rubber stopper and fosfomycin sodium for injection

[0033]

[0034] As can be...

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Abstract

The invention discloses a production method of a medicinal rubber plug. The production method includes: thermally treating a rubber plug under a vacuum condition; using water to rinse the rubber plug which is subjected to vacuum thermal treatment; subjecting the rubber plug which is rinsed to siliconization and drying to obtain the medicinal rubber plug. The production method is simple in process, pollution-free, easy for industrialization, energy saving and environment friendly. Extractable matter and extract in the medicinal butyl rubber plug which is treated by the production method are reduced to great extent, sealability of an original butyl rubber plug is unaffected, and the medicinal rubber plug can meet requirements of Standards YBB00042005 and / or YBB00052005 issued by the State Food and Drug Administration, can meet requirements on compatibility of special drug and can reach requirements of the Japanese Pharmacopoeia.

Description

technical field [0001] The invention belongs to the technical field of production of medicinal rubber stoppers, and in particular relates to a production method of medicinal rubber stoppers. Background technique [0002] Pharmaceutical rubber stoppers are special rubber products that are directly in contact with pharmaceuticals and are sealed and packaged. Therefore, the requirements for their performance, especially their chemical properties, are relatively strict. Nowadays, more than 90% of the rubber stoppers for medical packaging in the world are produced with butyl rubber as the base material, and the butylation of rubber stoppers for medical packaging has become the global first choice and an irreversible trend. [0003] In recent years, drug quality problems and adverse reactions caused by extractables and leaching substances in medicinal rubber stoppers, especially butyl rubber stoppers, have gradually increased, which has become one of the most concerned issues in t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08J7/12C08J7/00C08L23/28
Inventor 马东风代高峰刘梅玲李向阳
Owner 郑州翱翔医药科技股份有限公司
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