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Naproxen oral preparation and preparation method thereof

A technology for oral preparations and excipients, applied in the field of naproxen oral preparations and preparation thereof, achieves the effects of being convenient to take, increasing the dissolution rate, and improving the prescription and preparation process

Active Publication Date: 2022-05-27
海南久常制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Naproxen oral preparations are available on the market, including dosage forms such as naproxen tablets and naproxen capsules, but how to adjust naproxen in low pH hydrochloric acid solution through the improvement of naproxen oral preparation prescription and preparation process There are few relevant literature reports on the dissolution rate and dissolution rate in

Method used

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  • Naproxen oral preparation and preparation method thereof
  • Naproxen oral preparation and preparation method thereof
  • Naproxen oral preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Oral formulation of naproxen:

[0029]

[0030]

[0031] The preparation method of naproxen oral preparation:

[0032] (1) Mix the original naproxen powder, malic acid and proline (if there is no such ingredient in the recipe), and grind it at 25 to 30°C for 30 to 50 minutes (preferably 45 minutes in this example), and during the grinding process Add 40-50% ethanol aqueous solution (in this case, the preferred concentration is 50%) dropwise evenly, and after grinding, let it stand for at least 1h (in this case, preferably 1h) under the condition of ≤15°C (preferably 12°C in this case), and vacuum dry; Wherein, the dosage of the ethanol aqueous solution is 0.01 to 0.02 times (preferably 0.01 times in this example) of the total mass of the original naproxen powder.

[0033] (2) mixing the material treated in step (1) with the remaining auxiliary materials uniformly, and sieving; filling the uniformly mixed material into the capsule shell.

Embodiment 2

[0035] Oral formulation of naproxen:

[0036]

[0037] The preparation method of naproxen oral preparation:

[0038] (1) Mix the original naproxen powder, malic acid and proline, and grind them at 25 to 30°C for 30 to 50 minutes (preferably 45 minutes in this example), and evenly dropwise add 40 to 50% of Aqueous ethanol solution (preferably 50% in this example), after grinding, let stand for at least 1 hour (preferably 1 hour in this example) under the condition of ≤15°C (preferably 12°C in this case) to obtain material A;

[0039] (2) at normal temperature, add starch and calcium chloride in material A, evenly drop the sodium alginate aqueous solution (preferably 1% in this example) with a concentration of 1 to 1.5% dropwise and stir and mix, and vacuum dry; wherein, the consumption of the ethanol aqueous solution is 0.01 to 0.02 times the total mass of the original naproxen powder (preferably 0.01 times in this example).

[0040] (3) Filling the material processed in s...

Embodiment 3

[0042] Take prescription 6 formula and prepare capsules as follows:

[0043] (1) Mix the raw naproxen powder, malic acid and proline and grind at 25 to 30°C for 45 minutes, and evenly add 50% ethanol aqueous solution dropwise during the grinding process, and grind at 12°C after grinding. Stand for 1 hour, and vacuum dry; wherein, the amount of the ethanol aqueous solution is 0.01 times the total mass of the original naproxen powder.

[0044] (2) Mixing the material treated in step (1) with the remaining auxiliary materials uniformly, and filling the uniformly mixed material into the capsule shell.

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Abstract

The invention provides a naproxen oral preparation and a preparation method thereof, the naproxen oral preparation comprises naproxen raw powder and auxiliary materials, and the auxiliary materials comprise malic acid, proline, starch and calcium chloride. And auxiliary materials such as malic acid and proxen are added, so that the dissolution rate of naproxen is increased, and the dissolution of active pharmaceutical ingredients under an acidic condition is ensured. Through improvement of the preparation method, the dissolution rate and the dissolution rate of naproxen in a hydrochloric acid solution are further improved. The naproxen oral preparation provided by the invention is accurate in dosage, uniform in content, relatively small in internal medicine content difference, good in chemical stability and relatively convenient to carry, transport and take.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a naproxen oral preparation and a preparation method thereof. Background technique [0002] The chemical name of naproxen is: (S)-(+)-6-methoxy-α-methyl-2-naphthaleneacetic acid, molecular formula: C 14 H 14 O 3 ; molecular weight: 230.26. Naproxen is a non-steroidal anti-inflammatory drug, a PG synthase inhibitor, can inhibit prostate synthase, has significant analgesic and antipyretic effects, clinically used for the treatment of rheumatoid and rheumatoid arthritis, bone and joint It can also be used to relieve pain caused by musculoskeletal sprains, contusions, injuries and dysmenorrhea. [0003] Oral formulations refer to formulations that are administered orally. Oral administration is the most commonly used mode of administration for drug therapy, and the drug is absorbed through the gastrointestinal mucosa. Oral preparations have become a class of dosage forms that...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/22A61K9/08A61K31/192A61K47/02A61K47/12A61K47/22A61K47/36A61P19/02A61P29/00
CPCA61K31/192A61K9/0053A61K9/4866A61K9/4858A61K9/485A61K9/205A61K9/2013A61K9/2009A61K9/0095A61K47/02A61K47/12A61K47/22A61K47/36A61P19/02A61P29/00Y02A50/30
Inventor 魏雪纹戴宏旭吴海锋彭琪王宗达纪新明许宇丽
Owner 海南久常制药有限公司
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