Ibuprofen injection

A technology for injection and water for injection, which is applied in the direction of medical preparations of non-active ingredients, organic active ingredients, inorganic non-active ingredients, etc., and can solve problems such as potential safety hazards and safety needs to be studied

Inactive Publication Date: 2016-07-27
BEIJING LANDAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ibuprofen injection using arginine as a solubilizer is prone to precipitation in clinical compatibility studies, which leads to potential safety hazards
Tromethamine is an acid-base balance drug, which is clinically used for acute respiratory metabolic acidosis and alkalinization of urine, so the safety of using it as an excipient remains to be studied

Method used

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  • Ibuprofen injection
  • Ibuprofen injection
  • Ibuprofen injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] When the concentration of ibuprofen is 3mg / mL, Na 2 HPO 4 The molar ratio with ibuprofen is 0.5:1.

[0022] prescription

[0023]

[0024]

[0025] Preparation:

[0026] (1) The prescription amount Na 2 HPO 4 Add NaCl and water for injection and stir to mix evenly;

[0027] (2) Use 1M NaOH to adjust the pH to 11.5-12;

[0028] (3) After adding 3g of ibuprofen, heat and stir in a 40°C water bath for 20 minutes;

[0029] (4) filter, add water for injection to a sufficient amount;

[0030] (5) Sterilize (121°C, F0>12), and fill it.

Embodiment 2

[0032] When the concentration of ibuprofen is 3mg / mL, Na 2 HPO 4 The molar ratio with ibuprofen is 0.7:1.

[0033] prescription:

[0034] ibuprofen

3g

Na 2 HPO 4

1.445g

NaCl

6g

NaOH

Appropriate amount

Water for Injection

Add to 1000mL

[0035] Preparation:

[0036] (1) the prescription amount Na2HPO 4 Add NaCl and water for injection and stir to mix evenly;

[0037] (2) Use 1M NaOH to adjust the pH to 11.5-12;

[0038] (3) After adding 3g of ibuprofen, heat and stir in a 40°C water bath for 20 minutes;

[0039] (4) filter, add water for injection to a sufficient amount;

[0040] (5) Sterilize (121°C, F0>12), and fill it.

Embodiment 3

[0042] When the concentration of ibuprofen is 3mg / mL, Na 3 PO 4 The molar ratio with ibuprofen is 0.5:1. prescription:

[0043]

[0044]

[0045] Preparation:

[0046] (1) The prescription amount Na 3 PO 4 Add NaCl and water for injection and stir to mix evenly;

[0047] (2) After adding 3g of ibuprofen, heat and stir in a water bath at 40°C for 20 minutes;

[0048] (3) filter, add water for injection to a sufficient amount;

[0049] (4) Sterilize (121°C, F0>12), and fill it.

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Abstract

The invention provides an ibuprofen injection which includes ibuprofen, solubilizer and injection water.Solubilizer is selected from disodium hydrogen phosphate, dipotassium phosphate, sodium dihydrogen phosphate, monopotassium phosphate or any combination of disodium hydrogen phosphate, dipotassium phosphate, sodium dihydrogen phosphate and monopotassium phosphate and can also be selected from sodium phosphate, potassium phosphate or combination of sodium phosphate and potassium phosphate.Ibuprofen has concentration of 1-6 mg / ml and preferentially 2-4 mg / ml.The ibuprofen injection is high in stability in the transportation process, and the quality of a compatible product is not influenced in the clinical compatibility use process.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an ibuprofen injection. Background technique [0002] Ibuprofen is a clinically commonly used non-steroidal antipyretic analgesic anti-inflammatory drug, chemical name 2-(4-isobutylphenyl) propionic acid, mainly used for pain, inflammation and fever, and can also be used for Treatment of patent ductus arteriosus in premature infants. Ibuprofen has two enantiomers (R)-ibuprofen and (S)-ibuprofen, the (S) enantiomer is the biologically active form and the (R) enantiomer is in the body Convertible to the active (S) enantiomer, most ibuprofen formulations contain a racemic mixture. For simplicity, the term "ibuprofen" hereinafter is used to refer to any one of the (S) enantiomer, (R) enantiomer or racemate. [0003] Since ibuprofen was developed in the 1960s, it has been used as an oral preparation for a long time. Because ibuprofen has poor solubility in water...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61K47/04A61P29/00
CPCA61K9/0019A61K9/08A61K31/192A61K47/02
Inventor 林静文其他发明人请求不公开姓名
Owner BEIJING LANDAN PHARMA TECH
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