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Pharmaceutical packaging composition for injection and preparation method thereof

A technology for injection and composition, which is applied in the field of medicine, can solve the problems of rubber stopper compatibility, affect the quality of medicines, and complex formulations, etc., achieve strong resistance to water vapor permeability, ensure production efficiency, elasticity and flexibility good sex effect

Inactive Publication Date: 2012-09-19
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] In the prior art, a large number of common butyl rubber stoppers, sterile antibiotic glass bottles and sterile powders for injections are used to prepare injections. The performance is very good, but because of the complex formula and the concentration gradient of the added raw materials, after being encapsulated with some drugs with relatively strong molecular activity, it is easy to be absorbed, adsorbed, leached, penetrated by the drug, and will cause compatibility between the rubber plug and the drug. problems, thereby affecting the quality of medicines

Method used

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  • Pharmaceutical packaging composition for injection and preparation method thereof
  • Pharmaceutical packaging composition for injection and preparation method thereof
  • Pharmaceutical packaging composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A packaging composition of cefuroxime sodium for injection: an aluminum-plastic combination cover containing a rubber stopper, a sterile antibiotic glass bottle and a sterile powder of cefuroxime sodium for injection, and the weight of the sterile powder of cefuroxime sodium for injection is In terms of cefuroxime 0.75g, its preparation method comprises the following steps:

[0035] (1) To prepare film-coated rubber stoppers, first evaporate p-xylene at 150°C, then crack it at 680°C to generate stable active monomers, and finally the active monomers enter the deposition chamber at room temperature for polymerization and deposition. It is adsorbed on the rubber plug and polymerized to form a film, and the remaining gas is captured by a cold trap to prevent the deposit from entering the vacuum pump to obtain a film-coated rubber plug;

[0036] (2) Packing: put the sterile powder of cefuroxime sodium for injection into a sterile antibiotic glass bottle in the aseptic works...

Embodiment 2

[0039] A kind of packaging composition of cefoxitin sodium for injection: the aluminum-plastic combination cover that contains coated rubber stopper, sterile antibiotic glass bottle and cefoxitin sodium for injection aseptic powder, the weight of cefoxitin sodium for injection aseptic powder is In terms of cefoxitin 1.0g, its preparation method may further comprise the steps:

[0040] (1) To prepare film-coated rubber stoppers, first evaporate p-xylene at 150°C, then crack it at 680°C to generate stable active monomers, and finally the active monomers enter the deposition chamber at room temperature for polymerization and deposition. It is adsorbed on the rubber plug and polymerized to form a film, and the remaining gas is captured by a cold trap to prevent the deposit from entering the vacuum pump to obtain a film-coated rubber plug;

[0041] (2) Packing: in the aseptic workshop, put the sterile powder of cefoxitin sodium for injection into a sterile antibiotic glass bottle, ...

Embodiment 3

[0044] A kind of packaging composition of ceftriaxone sodium for injection: the aluminum-plastic combination cover that contains coated rubber stopper, sterile antibiotic glass bottle and ceftriaxone sodium for injection aseptic powder, the weight of ceftriaxone sodium for injection aseptic powder is In terms of ceftriaxone 1.0g, its preparation method may further comprise the steps:

[0045] (1) To prepare film-coated rubber stoppers, first evaporate p-xylene at 150°C, then crack it at 680°C to generate stable active monomers, and finally the active monomers enter the deposition chamber at room temperature for polymerization and deposition. It is adsorbed on the rubber plug and polymerized to form a film, and the remaining gas is captured by a cold trap to prevent the deposit from entering the vacuum pump to obtain a film-coated rubber plug;

[0046] (2) Packing: in the aseptic workshop, put the sterile powder of ceftriaxone sodium for injection into a sterile antibiotic glas...

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Abstract

The invention provides a pharmaceutical packaging composition for injection, which comprises the combination of an aluminum-plastic composition cover containing a coating plastic plug, a sterile antibiotic glass bottle and pharmaceutical sterile powder for injection, wherein the coating material of the coating plastic plug is polydimethylsiloxane coating, polyparaxylene coating, polytetrafluoroethylene coating, ethylene-tetrafluoroethylene copolymer coating, polyester coating, polyethylene coating or polypropylene coating; and the pharmaceutical sterile powder for injection is cephalo-type pharmaceutical sterile powder, such as cefuroxime sodium, cefoxitin sodium, cephazolin sodium and ceftriaxone sodium. The pharmaceutical packaging composition for injection is compatible with the pharmaceutical sterile powder for injection, so that the transition incidence rate is lower, and the quality risks of unqualified solution clarity due to compatibility and addition of related substances are reduced. The invention further provides a preparation method for the pharmaceutical packaging composition for injection, so that the obtained pharmaceutical packaging composition for injection can solve the compatibility problem very well and guarantee the stability of pharmaceutical quality.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a drug packaging composition for injection and a preparation method thereof. Background technique [0002] In the prior art, a large number of common butyl rubber stoppers, sterile antibiotic glass bottles and sterile powders for injections are used to prepare injections. The performance is very good, but because of the complex formula and the concentration gradient of the added raw materials, after being encapsulated with some drugs with relatively strong molecular activity, it is easy to be absorbed, adsorbed, leached, penetrated by the drug, and will cause compatibility between the rubber plug and the drug. problems, thereby affecting the quality of medicines. Among them, cephalosporins are more prominent. In order to effectively control product quality and ensure drug safety, a safer drug packaging is needed to meet the needs of production, life and medical care. Contents...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J1/00
Inventor 闫志刚邓宝军王磊曾环想王泳程莹莹李娟权超王绛玉
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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