Ibuprofen injection and preparation method

A technology for injection and water for injection, applied in the field of medicine, can solve the problems of unstable raw materials of ibuprofen and prone to crystallization, and achieve the effect of excellent product quality and stability

Inactive Publication Date: 2020-01-17
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The ibuprofen raw material is insoluble in water and unstable, and is easily oxidized to produce a series of degraded impurities. In clinical use, it is prone to crystallization when it is compatible with sodium chloride and glucose infusion

Method used

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  • Ibuprofen injection and preparation method
  • Ibuprofen injection and preparation method
  • Ibuprofen injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] prescription:

[0021] Ibuprofen 8.0g

[0022] Arginine 6.2g

[0023] Add water for injection to 80ml

[0024] Preparation method: take an appropriate amount of water for injection and pass it with nitrogen gas for 30 minutes, seal it for later use; take the above water for injection with a liquid volume of 80%, add ibuprofen and stir at 70-80°C, then add the prescribed amount of arginine and stir to dissolve, and constant volume , control the pH in the range of 7.8-8.8, replenish the water to the full amount; add activated carbon for needles with a liquid volume of 0.1% (0.1g / 100ml), stir and adsorb at room temperature for 20min, and decarburize by filtering through a 0.45μm microporous membrane; The 0.45 μm microporous membrane is filtered twice, and nitrogen is protected; the ampoule is filled with nitrogen, and then filled with liquid medicine, nitrogen, and sealed; sterilized by autoclaving at 121 ° C for 15 minutes.

Embodiment 2

[0026] prescription:

[0027] Ibuprofen 8.0g

[0028] Arginine 6.7g

[0029] Add water for injection to 80ml

[0030] Preparation method: take an appropriate amount of water for injection, pass nitrogen gas for 30 minutes, and seal it for later use; take the above-mentioned water for injection with a dosing volume of 80%, add ibuprofen and stir at 70-80°C, then add the prescribed amount of arginine, stir to dissolve, and set to control the pH in the range of 7.8-8.8; add activated carbon for needles with a dosing volume of 0.1% (0.1g / 100ml), stir and adsorb at room temperature for 20min, and decarburize by filtration through a 0.45μm microporous membrane; the liquid is passed through a 0.45μm The microporous filter membrane is filtered twice, and nitrogen protection is passed; the ampoule is filled with nitrogen gas, then filled with liquid medicine, nitrogen gas is passed, and the seal is sealed; sterilized by autoclaving at 121°C for 15 minutes.

Embodiment 3

[0032] prescription:

[0033] Ibuprofen 8.0g

[0034] Arginine 7.0g

[0035] Add water for injection to 80ml

[0036] Preparation method: take an appropriate amount of water for injection, pass nitrogen gas for 30 minutes, and seal it for later use; take the above-mentioned water for injection with a dosing volume of 80%, add ibuprofen and stir at 70-80°C, then add the prescribed amount of arginine, stir to dissolve, and set to control the pH in the range of 7.8-8.8; add activated carbon for needles with a dosing volume of 0.1% (0.1g / 100ml), stir and adsorb at room temperature for 20min, and decarburize by filtration through a 0.45μm microporous membrane; the liquid is passed through a 0.45μm The microporous filter membrane is filtered twice, and nitrogen protection is passed; the ampoule is filled with nitrogen gas, then filled with liquid medicine, nitrogen gas is passed, and the seal is sealed; sterilized by autoclaving at 121°C for 15 minutes.

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PUM

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Abstract

The invention relates to an ibuprofen injection. A prescription of the injection comprises a main drug ibuprofen and a cosolvent arginine, the dose of arginine in the prescription is 83.75 mg / ml-95 mg / ml, the molar ratio of the arginine to the ibuprofen is 0.99:1-1.18:1, and the pH value range of the injection is 7.8-8.8. The prepared product is superior to the prior art in quality and has good stability and safety.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to an ibuprofen injection and a preparation method thereof. Background technique [0002] In 1968, the oral formulation of ibuprofen was first launched in the UK by the British Boots Company for the treatment of mild to moderate pain and fever. Up to now, it has been used for more than 50 years. Compared with other antipyretic and analgesic drugs, ibuprofen has better clinical effect and less side effects. In my country, it is also one of the medicines with the most dosage forms among antipyretic and analgesic drugs. In June 2009, the ibuprofen injection developed by the original research company Cumberland Pharmaceutical Preparations Co., Ltd. was launched in the United States under the trade name: Caldolor. The product is the first approved intravenous formulation for the treatment of pain and fever. Compared with ibuprofen oral preparations, ibuprofen injection ha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K47/02A61K31/192A61P29/00
CPCA61K9/0019A61K9/08A61K31/192A61K47/02A61K47/183A61P29/00
Inventor 陈雨张孝刚闫正伦刘庆利管章伟
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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