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Ibuprofen arginine granule and preparation method thereof

The technology of arginine ibuprofen and granules is applied in the directions of anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc. Simple, sweet and bioavailable

Active Publication Date: 2013-03-13
HEFEI KEDA BIO TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to overcome the disadvantages of the arginine ibuprofen granules in the prior art, such as cumbersome preparation process, poor mouthfeel, and unsuitability for children to take, the object of the present invention is to provide an arginine ibuprofen granule

Method used

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  • Ibuprofen arginine granule and preparation method thereof
  • Ibuprofen arginine granule and preparation method thereof
  • Ibuprofen arginine granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] The detailed screening process of arginine ibuprofen granule of the present invention is as follows:

[0068] 1. Filler screening

[0069] Arginine ibuprofen has good water solubility, but it has a pungent taste when dissolved in water, so fillers are added to the prescription to observe the solubility and taste changes of the product. The screening results are shown in Table 1.

[0070] Table 1 Screening of fillers (unit: g, packed in 0.2g / bag)

[0071]

[0072]

[0073] Note: The taste participants include 5 adults, 5 males and 5 females, and 5 children (under 12 years old), 5 males and 5 females each.

[0074] Conclusion: Since arginine ibuprofen is easily soluble in water and has a spicy taste when dissolved in water, a filler with good solubility and sweet taste is added. However, the added filler can only be used to form the shape and adjust the sweetness of the solution taste, and cannot completely cover the pungent taste of the raw material drug itself....

Embodiment 2

[0095] Pass arginine ibuprofen, sucrose, hydroxypropyl beta-cyclodextrin and sodium cyclamate through a 100-mesh sieve respectively, and set aside. Weigh the raw and auxiliary materials of the following prescription quantities:

[0096]

[0097] Mix sodium cyclamate and sucrose evenly (mix for 20 minutes), and then mix the resulting mixture with arginine ibuprofen and hydroxypropyl beta cyclodextrin (mix for 30 minutes), then add 2% hypromellose Su K4M 50% ethanol aqueous solution (dissolve hypromellose K4M in 50% ethanol aqueous solution by volume, wherein the mass percent concentration of hypromellose K4M is 2%) to make soft materials, using 18 Mesh sieve granulation, air drying at 60°C for about 2 hours after granulation, granulation with a 16 mesh sieve, mixing the obtained granules with orange flavor for about 3 minutes to obtain arginine ibuprofen granules, after passing the inspection, subpackage into corresponding specifications / bags.

Embodiment 3

[0099] Pass arginine ibuprofen, mannitol, hypromellose K4M, and aspartame through a 100-mesh sieve respectively, and set aside.

[0100] Weigh the raw and auxiliary materials of the following prescription quantities:

[0101]

[0102] Mix aspartame and mannitol evenly (mix for 30 minutes), and then mix the resulting mixture with arginine ibuprofen and hypromellose K4M (mix for 30 minutes), and then add 70% concentration by volume Ethanol aqueous solution is used to make soft material, granulated with 18-mesh sieve, air-dried at 60°C for about 2 hours after granulation, granulated with 16-mesh sieve, and mixed with orange flavor for about 2 minutes to obtain arginine bulo Fen granules, after passing the inspection, are packed into corresponding specifications / bags.

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Abstract

The invention relates to an ibuprofen arginine granule, which is composed of ibuprofen arginine, a filler, a taste masking agent, an adhesive, a flavoring agent, a smelling agent, and a coloring agent by weight part. The invention also provides a preparation method of the ibuprofen arginine granule. The ibuprofen arginine granule provided by the invention covers up the intrinsic spicy taste of ibuprofen arginine, and has the advantages of good children compliance, fast effect, simple prescription composition, easily available and cheap auxiliary materials with fewer variety and dosage, and no need of coating. The preparation method has the characteristics of simple process, easy operation, no need for special equipment, short production cycle, and low cost, thus being suitable for industrialized production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an arginine ibuprofen granule and a preparation method thereof. Background technique [0002] The traditional antipyretic and analgesic ibuprofen is almost insoluble in water, and the pharmacokinetic parameter T max The value is 1.5 to 2 hours, and like other oral NSAIDs (non-steroidal anti-inflammatory drugs), the onset of action is relatively slow. According to the actual situation, Zambon S.P.A. company in Italy solved this problem in 1986 and developed the salt of ibuprofen combined with arginine (CH673394): due to the combination of arginine, the water insolubility of ibuprofen is changed, making the ibuprofen in the body The rate of absorption increases, reaching the maximum plasma concentration (C max ) time decreases, the maximum plasma concentration increases, especially T max The value is reduced from 1.5 to 2 hours to 15 to 30 minutes. [0003] The ibupro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/205A61K31/192A61K47/40A61K47/26A61K9/16A61P29/00
Inventor 王刚胡群芳俞林龙
Owner HEFEI KEDA BIO TECH CO LTD
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