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Injection liquid containing ibuprofen and preparation process of injection liquid

A preparation process and injection technology, which is applied in the field of medicine, can solve the problems of high cost and large amount of arginine required, and achieve the effects of high safety, avoiding adverse reactions, and stable quality

Inactive Publication Date: 2012-10-10
无锡康福特药物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008] In the patent CN201010293328.9, it is recommended that the molar ratio of ibuprofen and arginine be 1:1.001-2 for the formula composed of ibuprofen and co-solvent (arginine), which can ensure that the ibuprofen is at an appropriate pH value. Fen will not be precipitated, but a pH regulator must be used to lower the pH value to reach the acceptable range of human blood, and the amount of arginine used as a pharmaceutical excipient increases, and the cost also increases

Method used

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  • Injection liquid containing ibuprofen and preparation process of injection liquid
  • Injection liquid containing ibuprofen and preparation process of injection liquid
  • Injection liquid containing ibuprofen and preparation process of injection liquid

Examples

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Effect test

Embodiment 1

[0037] Each 200 sticks of ibuprofen injection contains the following ingredients: ibuprofen 80.000g (0.388mol); arginine 67.551g (0.388mol); water for injection 800mL.

[0038] Preparation process of injection containing ibuprofen

[0039] (1) Washing of ampoule: take a neutral glass ampoule (specification 5mL), fill the ampoule with deionized water first, boil at 100°C for 30 minutes, shake off the water while it is hot, rinse twice with fresh water for injection, and immediately place in Put it in an oven at 160°C for 2 hours, take it out and let it cool for later use.

[0040] (2) Dosing: first take the prescribed amount of arginine, add 700mL of ultrasonically treated water for injection, stir to dissolve, then add the prescribed amount of ibuprofen, and ultrasonically stir to dissolve, measure the pH value to 7.8~8.0, and then add water for injection The whole amount, stir evenly, add 0.1% (w / v) activated carbon for needles and stir at 55°C for 30min. First filter the d...

Embodiment 2

[0044] Each 200 ibuprofen injection contains the following ingredients: ibuprofen 160.000g (0.776mol); arginine 135.108g (0.776mol); water for injection 1600mL.

[0045] The preparation process of the injection containing ibuprofen:

[0046] (1) Washing of ampoule: take a neutral glass ampoule (specification 10mL), fill the ampoule with deionized water first, boil at 100°C for 30 minutes, shake off the water while it is hot, rinse twice with fresh water for injection, and immediately place in Put it in an oven at 160°C for 2 hours, take it out and let it cool for later use.

[0047] (2) Dosing: first take the prescribed amount of arginine, add 1400mL of ultrasonically treated water for injection, stir to dissolve, then add the prescribed amount of ibuprofen, ultrasonically stir to dissolve, measure the pH value of 7.8~8.0, and then add water for injection to The whole amount, stir evenly, add 0.2% (w / v, mass: volume) activated carbon for needles and stir at 60°C for 40min. F...

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Abstract

The invention relates to a proportioning method of ibuprofen injection liquid, a preparation process and relevant substance limitation and belongs to the technical field of medicine. The medical auxiliary materials of the injection liquid are arginine, the injection liquid is prepared by mixing the ibuprofen and arginine according to a mol ratio, the total quantity of relevant substances in the injection liquid is lower than 0.5 percent, and in addition, the content of each kind of impurities is respectively lower than 0.1 percent. The pH value of the injection liquid is controlled in a range that the ibuprofen can be completely dissolved, and the crystal separation phenomenon cannot occur. The content of relevant substances of the injection liquid is strictly controlled in a certain range so that the adverse effect generated on human bodied is avoided to the furthest degree during the intravenous drip on patients, and the safety is higher. The ibuprofen injection liquid provided by the invention has the advantages that the preparation process is simple, the operation is easy, the efficiency is high, and products with stable quality can be prepared.

Description

technical field [0001] The invention relates to a compounding method, a preparation process and the limit of related substances of ibuprofen injection, which belong to the technical field of medicine. Background technique [0002] Ibuprofen is a class of non-steroidal anti-inflammatory drugs that have been used for many years. It is an effective PGase synthesis inhibitor and has good anti-inflammatory, antipyretic and analgesic effects. It is widely used in the treatment of arthritis and various Pain caused by inflammation. It is especially suitable for the treatment of rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and neuritis, etc. In addition, it is the only antipyretic drug for children jointly recommended by the World Health Organization and the US FDA, and is recognized as the first choice antipyretic drug for children. [0003] Ibuprofen was first launched in the UK in 1968. Due to its remarkable antipyretic and analgesic effects...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/192A61K47/16A61P29/00
Inventor 毛宇锋邓锋李文燕
Owner 无锡康福特药物科技有限公司
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