Naproxen injection and preparation method thereof

A technology for injection and naproxen, applied in the field of naproxen injection and preparation thereof, can solve the problems of unseen, difficult to control impurities, increased manufacturing cost and the like, and achieve the effects of improved solubility, low production cost and reduced transportation cost

Pending Publication Date: 2020-05-19
HUBEI XINGHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Commercially available naproxen raw materials are mostly used to prepare oral preparations such as tablets and capsules, and naproxen sodium is also used to prepare solution-type preparations, such as eye drops, injections, etc., but naproxen sodium needs to use naproxen and alkali Salt formation

Method used

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  • Naproxen injection and preparation method thereof
  • Naproxen injection and preparation method thereof
  • Naproxen injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A naproxen injection prepared from the following raw materials:

[0031]

[0032]

[0033] The preparation method of above-mentioned naproxen injection, its steps are:

[0034] 1) Sodium hydroxide is mixed with water for injection to prepare a sodium hydroxide solution with a concentration of 12% by mass;

[0035] 2) First add naproxen to the remaining water for injection, then add sodium hydroxide solution, and continue to stir until the naproxen is completely dissolved, then add sodium sulfite and disodium edetate, and stir evenly. The pH value is 8.5, then add activated carbon, stir evenly and let stand for 26 minutes, then filter (remove activated carbon), fill, fill with nitrogen, seal, and finally sterilize at 117°C for 32 minutes to obtain the described naproxen Raw injections.

[0036] Test 1, the stability test of the naproxen injection of the present invention.

[0037] According to the requirements of "Technical Specifications for Drug Stability Test...

Embodiment 2

[0048] A kind of naproxen injection, is prepared from the raw material of following mass percentage:

[0049]

[0050] The preparation method of this naproxen injection, its steps are:

[0051] 1) sodium hydroxide is made into a sodium hydroxide solution with a mass percent concentration of 8% with water for injection;

[0052] 2) First add naproxen to the remaining water for injection, then add sodium hydroxide solution, and continue to stir until the naproxen is completely dissolved, then add disodium edetate and sodium citrate, and stir evenly. When the pH value of the system is 9.0, add activated carbon, stir evenly and let it stand for 20 minutes, remove the activated carbon, filter, fill, fill with nitrogen, seal, and finally sterilize at 115°C for 35 minutes to obtain the described Naproxen injection.

Embodiment 3

[0054] A kind of naproxen injection, is prepared from the raw material of following mass percentage:

[0055]

[0056]

[0057] The preparation method of this naproxen injection, its steps are:

[0058] 1) Sodium hydroxide is prepared into a 15% sodium hydroxide solution with water for injection.

[0059] 2) First add naproxen to the remaining water for injection, then add sodium hydroxide solution, and continue to stir until the naproxen is completely dissolved, then add disodium edetate and sodium citrate, and stir evenly. When the pH value of the system is 8.5, then add activated carbon, stir evenly and let it stand for 23 minutes, remove the activated carbon, then filter, fill, fill with nitrogen, seal, and finally sterilize at 121°C for 25 minutes to obtain the described Naproxen injection.

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PUM

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Abstract

The invention discloses a naproxen injection and a preparation method thereof. The naproxen injection is prepared from a certain proportion of naproxen, a salt-forming agent, a complexing agent, a stabilizer, an adsorbent and water for injection. The preparation method comprises the following steps: 1) preparing a salt-forming agent solution from the salt-forming agent by using the water for injection; and 2) adding the naproxen into the remaining water for injection, adding the salt-forming agent solution, performing continuous stirring until the naproxen is completely dissolved, adding the complexing agent and the stabilizer, performing uniform stirring, wherein the pH value of the system at the time is 7.5-9.0, adding the adsorbent, performing uniform stirring, allowing the mixture to stand for 20-30 min, performing filtration, performing filling, introducing nitrogen, performing sealing, and finally performing sterilization for 25-35 min at 115-121 DEG C. The injection has high stability, and can be used for intramuscular administration, the administration is convenient and rapid, and the injection has a small preparation volume, and is convenient for transportation, and low intransportation cost.

Description

technical field [0001] The invention belongs to the technical field of clinical preparations, and in particular relates to a naproxen injection and a preparation method thereof. Background technique [0002] Naproxen, also known as methoxyisopropionic acid, is an aryl propionic acid non-steroidal drug, white or off-white powder crystal, chemical name (+)—α—methyl—6—methoxy— 2—Naphthylacetic acid, odorless or almost odorless, almost insoluble in water, soluble in methanol or chloroform. The drug has good anti-inflammatory, antipyretic, and analgesic effects, and has less adverse reactions. Naproxen can obviously inhibit the synthesis of prostaglandins, and can reduce or even stop the release of prostaglandins, so it has strong anti-inflammatory, antipyretic and analgesic effects. The anti-inflammatory effect of naproxen is 11 times that of phenylbutazone, the antipyretic effect is 22 times that of aspirin, and the analgesic effect is 7 times that of aspirin. Naproxen is cl...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61K47/18A61P29/00
CPCA61K9/0019A61K9/08A61K31/192A61K47/183A61P29/00
Inventor 张小刚
Owner HUBEI XINGHUA PHARMA CO LTD
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