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A refining method and technology of preparation steps, applied in the field of medicine, can solve the problems of not being able to reach the injection level, unknown side effects, many adverse reactions, and high impurity content, and achieve the effects of avoiding adverse reactions, easy operation, and simple process
Inactive Publication Date: 2013-01-16
WUXI XINRENTANG PHARMA TECH
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Problems solved by technology
However, there is no generic drug of this drug formulation on the market in China, and the current commercially available ibuprofen is an oral-grade raw material drug, which generally has a high impurity content and cannot reach the injection level for injection.
As an injection preparation, if the content of impurities is higher, the unknown side effects and adverse reactions that will be caused when the liquid medicine is injected into the human body will be more.
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Embodiment 1
[0028] Refining process of ibuprofen:
[0029] (1) Precisely weigh 40.00g of ibuprofen, put it in a 500mL round bottom flask, add 320mL of petroleum ether, and shake to dissolve completely;
[0030] (2) In the dissolved ibuprofen petroleum ether solution, add 0.05% activated carbon accounting for the mass volume ratio of the total solution;
[0031] (3) Heating in a water bath to 75°C for reflux reaction for 40 minutes;
[0032] (4) Filter out the activated carbon while it is hot;
[0033] (5) Allow the obtained filtrate to stand at room temperature and then crystallize overnight at -7°C;
[0034] (6) Remove petroleum ether by filtration to obtain ibuprofen filter cake;
[0035] (7) Grind the above filter cake into powder, dry in vacuum at 50°C for 3 hours and weigh to obtain the final product of ibuprofen.
Embodiment 2
[0037] Refining process of ibuprofen:
[0038] (1) Precisely weigh 80.00g of ibuprofen, place it in a 1000mL round bottom flask, add 640mL of 70% ethanol solution, and shake to dissolve completely;
[0039] (2) Add 0.2% activated carbon to the dissolved ibuprofen 70% ethanol solution;
[0040] (3) Heating in a water bath to 65°C for reflux reaction for 30 minutes;
[0041] (4) Filter out the activated carbon while it is hot;
[0042] (5) Allow the obtained filtrate to stand at room temperature and then crystallize overnight at -7°C;
[0043] (6) Remove 70% ethanol solution by filtration to obtain ibuprofen filter cake;
[0044] (7) Grind the above filter cake into powder, dry in vacuum at 40°C for 3 hours and weigh to obtain the final product of ibuprofen.
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Abstract
The invention discloses a refining method of ibuprofen, particularly relating to a refining process of the ibuprofen, impurity limit and quality comparison with the commercially available ibuprofen at present, and belonging to the technical field of medicine. The ibuprofen is mainly dissolved by using an organic solvent, active carbon is added for reflux decolorizing and then solution is crystallized, filtered, ground, dried and weighed to obtain a finished product, i.e., refined ibuprofen. According to the product prepared by the invention, the impurity content of the ibuprofen can be strictly controlled within a certain range, and requirements of all formations including injection can be met, so that adverse reaction produced to a human body can be avoided to the greatest extent and the safety is higher during intravenous drip and other administration approaches of a patient. The refining process of the ibuprofen has the advantages of simplicity, easiness in operation, high efficiency and capability of preparing a product with stable quality.
Description
technical field [0001] The invention relates to a refining method of ibuprofen, in particular to a refining process of ibuprofen, the limit of impurities and its quality comparison with the current commercially available ibuprofen, and belongs to the technical field of medicine. Background technique [0002] Ibuprofen, also known as 2-(4-isobutylphenyl) propionic acid, is a class of non-steroidal anti-inflammatory drugs that have been used for many years. It has good anti-inflammatory, antipyretic and analgesic effects, and is especially suitable for the treatment of Rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and neuritis, etc. [0003] Ibuprofen was first launched in the UK in 1968. Due to its remarkable antipyretic and analgesic effects and low toxicity, it is better than aspirin and paracetamol, so the market has expanded rapidly. Due to the better curative effect and less adverse reactions of ibuprofen, in the late 1980s, the Unit...
Claims
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