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Dexketoprofen injection and preparation method thereof

A technology of dexketoprofen and injection, which is applied in the field of medicine, can solve the problems of increasing drug delivery routes, small side effects, and small doses, and achieve the effects of reducing the process of arteriosclerosis, small side effects, and small doses

Active Publication Date: 2014-06-18
西安远大德天药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The injection adopts dexketoprofen to replace racemic ketoprofen, the dose is small, the side effect is small, and basic amino acid is used as a cosolvent, which solves the solubility problem of dexketoprofen and overcomes the problem of existing preparations. Insufficient of other co-solvents, in addition, the analgesic benzyl alcohol is not used in the injection, which can be injected intravenously, which increases the route of drug administration; no organic solvent is used, which is safer

Method used

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  • Dexketoprofen injection and preparation method thereof
  • Dexketoprofen injection and preparation method thereof
  • Dexketoprofen injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0028] The dexketoprofen injection of the present embodiment comprises dexketoprofen, L-arginine and water for injection, wherein every 1000mL of the dexketoprofen injection contains 25g dexketoprofen; The mol ratio of described dexketoprofen and L-arginine is 1: 1.

[0029] The preparation method of the dexketoprofen injection of the present embodiment is:

[0030] Step 1, adding 3 times the mass percent concentration of the bulk drug quality to the oral grade dexketoprofen bulk drug is 45% ethanol, and heating to reflux at a temperature of 50°C makes the dexketoprofen bulk drug completely dissolve , then add 0.2% activated carbon to the dissolved solution, heat it for 10 minutes and filter it while it is hot, place the filtered filtrate at -4°C overnight or cool it with cold water to precipitate crystals, and filter it with suction to obtain purified dexketorol Fern;

[0031] Step 2. Dissolve 4.29g of L-arginine in 200mL of water for injection, then add 6.25g of the purifi...

Embodiment 2

[0035] The dexketoprofen injection of the present embodiment comprises dexketoprofen, lysine and water for injection, wherein every 1000mL of the dexketoprofen injection contains 25g dexketoprofen; The mol ratio of ketoprofen and lysine is 1: 0.5.

[0036] The preparation method of the dexketoprofen injection of the present embodiment is:

[0037] Step 1, adding 5 times the mass percentage concentration of the raw material drug to the oral grade dexketoprofen raw material drug is 40% ethanol, and heating and refluxing at a temperature of 40°C makes the dexketoprofen raw material drug completely dissolve , then add 0.5% activated carbon of the solution mass to the dissolved solution, keep warm for 10 minutes and filter while it is hot, place the filtered filtrate at 4°C overnight or cool it with cold water to precipitate crystals, filter with suction to obtain purified dexketoprofen ;

[0038] Step 2. Dissolve 1.8 g of lysine in 200 mL of water for injection, then add 6.25 g ...

Embodiment 3

[0042] The dexketoprofen injection of the present embodiment comprises dexketoprofen, histidine and water for injection, wherein every 1000mL of the dexketoprofen injection contains 25g dexketoprofen; The molar ratio of ketoprofen to histidine is 1: 1.5.

[0043] The preparation method of the dexketoprofen injection of the present embodiment is:

[0044] Step 1, adding 2 times the mass percentage concentration of the raw material drug to the oral grade dexketoprofen raw material drug is 50% ethanol, and heating and refluxing at a temperature of 60 ° C makes the dexketoprofen raw material drug completely dissolved , then add activated carbon of 0.05% solution mass to the dissolved solution, keep warm for 15min and filter while it is hot, place the filtered filtrate at 4°C overnight or cool it with cold water to precipitate crystals, filter with suction to obtain purified dexketoprofen ;

[0045] Step 2. Dissolve 5.71 g of histidine in 200 mL of water for injection, then add 6...

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Abstract

The invention discloses a dexketoprofen injection which contains dexketoprofen, an alkaline latent solvent and water for injection, wherein 25g dexketoprofen is contained in the dexketoprofen injection per 1000mL; the molar ratio of the dexketoprofen to the alkaline latent solvent is (1: 0.5)-1.5; and the alkaline latent solvent is alkaline amino acid. In addition, the invention further discloses a preparation method of the injection. In the injection, racemic ketoprofen is replaced by the dexketoprofen, so dosage is little, and side effect is small; and alkaline amino acid is used as a latent solvent, which solves the solubility problem of the dexketoprofen and also overcomes the shortcomings of other latent solvents used in the current preparation; furthermore, the injection can be administered in an intravenous drip way owing to no use of painkiller phenylcarbinol in the injection, thus increasing the medicine administration way; and better safety is ensured because an organic solvent is not used.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a dexketoprofen injection and a preparation method thereof. Background technique [0002] Ketoprofen is a non-steroidal anti-inflammatory drug (NSAI dexketoprofen injection), currently clinically used in rheumatoid arthritis, rheumatoid arthritis, ankylosing spondylitis, gout, osteoarthritis Arthritis, hemophilic arthritis, cervical and lumbar spondylosis, migraine, trauma, and postoperative pain. Because ketoprofen is an organic acid drug, insoluble in water, gastrointestinal administration is mainly distributed in the stomach, small intestine and kidney, and has relatively large side effects on the gastrointestinal tract. Reaction of ketoprofen with an organic base to form an alkyl ammonium salt can increase the water solubility of ketoprofen, reduce the stimulation to blood vessels or muscles, reduce the tolerance of patients to this drug, and further expand the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/192A61K47/18A61K47/22A61P29/00
Inventor 唐星王亚轩
Owner 西安远大德天药业股份有限公司
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