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High-stability ibuprofen injection and preparation method thereof

A high stability, injection technology, applied in pharmaceutical formulations, organic active ingredients, non-central analgesics, etc., can solve the problem of lack of nitrogen protection, low solution stability, alkaline stabilizer and buffer salt safety Risks and other issues, to achieve the effects of high compatibility stability, prevention of oxidative deterioration, and stable quality indicators

Inactive Publication Date: 2013-04-17
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In terms of patent applications, the Chinese invention patent application publication discloses a pharmaceutical composition named "2-(4-isobutylphenyl)propionic acid", the application number is 01823764.9, the authorized publication number is CN1302771C, and the application date is 2001 On November 2, 2009, the application mainly provided a pharmaceutical composition containing arginine and ibuprofen aqueous solution and its preparation method, wherein the molar ratio of arginine to ibuprofen was less than 1:1, and the composition was prepared Nitrogen protection and pH adjustment are not carried out, and the clinical compatibility has great limitations
In addition, there are related ibuprofen injection patents, and their preparation methods have more or less defects. For example, the Chinese invention patent application publication discloses a name "Preparation method of ibuprofen injection", application number It is 201010277556.7, the authorized publication number is 101940547A, and the application date is January 12, 2011. This application mainly provides a preparation method of ibuprofen injection containing ibuprofen and alkaline co-solvent. Although the method emphasizes the The pH of ibuprofen injection was adjusted to 7.0-9.0, but nitrogen protection was not carried out. The amount and type of alkaline stabilizers and buffer salts used would bring certain safety risks to clinical use.
In addition, the publication specification of the Chinese invention patent application discloses a kind of "an ibuprofen injection and its preparation method", the application number: 201110023170.8, and the application date is January 20, 2011. This application mainly provides a The preparation method of the ibuprofen injection containing ibuprofen and alkaline co-solvent, this method adopts various alkaline inorganic salts to aid dissolution, the stability of the solution formed is not high, and clinical compatible use also has certain safety problems

Method used

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  • High-stability ibuprofen injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] prescription:

[0030]

[0031] Weigh arginine according to the prescription amount, take 80% of the total amount of water for injection, pass nitrogen to deoxygenate for 20 minutes, add arginine to dissolve, add ibuprofen raw material under stirring, and stir until completely dissolved while adding; add injection Water to the total amount, adjust the pH of the solution with 4% sodium hydroxide solution; add 0.1% of the total volume of activated carbon, heat and stir for 15 minutes, decolorize, filter through a 0.22 μm membrane; fill with nitrogen, fill in a 5ml ampoule, Sterilize at 121°C for 15 minutes; shorten the cooling time after sterilization as much as possible, and the measured pH after sterilization is 7.40.

Embodiment 2

[0033] The specific process is the same as that in Example 1, except that nitrogen flow and nitrogen protection are not carried out during the whole preparation process.

Embodiment 3

[0035] prescription:

[0036]

[0037] The specific process is the same as in Example 1, except that the prescription amount of cosolvent arginine is different.

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Abstract

The invention relates to high-stability ibuprofen injection and a preparation method thereof. The injection comprises the following components of arginine, ibuprofen and water for injection, wherein the mol ratio of the arginine to the ibuprofen is (0.85-0.95): 1; the weight / volume ratio of the ibuprofen in the injection is 10 percent; the weight / volume ratio of the arginine in the injection is 7.2-8.0 percent; and the pH value of the injection is 7.5-8.5. The method creatively adopts the fewest and the smallest accessories to solve the stability difficulty of the ibuprofen injection, and successfully prepares the ibuprofen injection with safety in clinical use and good stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a highly stable ibuprofen injection and a preparation method thereof. Background technique [0002] Ibuprofen (Ibuprofen), also known as ibuprofen, is a non-steroidal anti-inflammatory analgesic. Its anti-inflammatory, analgesic, and antipyretic effects are good, and its adverse reactions are small. At present, it has been widely used in the world and has become one of the best-selling over-the-counter drugs in the world. It is listed as the three pillar products of antipyretic and analgesic drugs together with aspirin and paracetamol. In addition to being recorded in the Chinese Pharmacopoeia, it has also been included in the pharmacopoeias of the United States, Britain, Japan and other countries. Ibuprofen was first listed in the UK in 1968. The manufacturer is the British Boots Company, and the trade name is Brufen. Because it has both antirheumatic and antipyreti...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61K47/18A61P29/00
Inventor 吕美红孙备刘甜甜尹双青刘永宏
Owner 蚌埠丰原涂山制药有限公司
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