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Method for preparing composition granules containing ibuprofen amino guanidyl valeric acid

A technology of arginine and composition, which is applied in the field of particle preparation containing ibuprofen arginine composition, can solve the problems of irritating odor formulation, seriousness, limitation and the like, and achieves overcoming easy moisture absorption and high bioavailability , good stability

Active Publication Date: 2004-09-15
SUNSTONE TANGSHAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] But according to the prior art, it is very difficult to make ibuprofen arginine into solid preparations, especially when it is made into granules and tablets. Specific dosage forms are limited

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: Preparation of ibuprofen arginine granules

[0021] The first step (granulation stage): 45.5 grams of polyvinylpyrrolidone (PVP) is made into 650 milliliters of PVP ethanol solution of 7% gram / ml, 2.4 grams of hydroxypropyl methylcellulose (HPMC) are made into 8% gram 30 milliliters of HPMC aqueous solution per milliliter, ibuprofen arginine 740g, mannitol 400g, lactose 610g, and above-mentioned 7% gram / ml PVP ethanol solution 650 milliliters, 8% gram / ml HPMC aqueous solution 30 milliliters are fully mixed, Pass through a 30-mesh sieve and set aside.

[0022] The second step (coating stage):

[0023] Preparation of coating solution:

[0024] a. 200g of sodium bicarbonate is dissolved in an appropriate amount of pure water to obtain a solution;

[0025] b. Add 5g of silicon dioxide and 76g of ethyl cellulose to 80ml of ethanol

[0026] and stir the mixture until a homogeneous dispersion is formed;

[0027] c. Mix the solution obtained in step a with th...

Embodiment 2

[0030] Embodiment 2: Preparation of ibuprofen arginine granules

[0031] The first step (granulation stage): 62.3 grams of polyvinylpyrrolidone (PVP) is made into 890 milliliters of PVP ethanol solution of 7% gram / ml, 4.8 grams of hydroxypropyl methylcellulose (HPMC) are made into 8% gram 60 milliliters of HPMC aqueous solution per milliliter, main ingredient ibuprofen arginine 740g, mannitol 1000g, sucrose 955g, 7% gram / ml PVP ethanol solution 890 milliliters, 8% gram / ml HPMC aqueous solution 60 milliliters fully mix, Pass through a 60-mesh sieve and set aside.

[0032] The second step (coating stage):

[0033] Preparation of coating solution:

[0034] A. 592g sodium bicarbonate is dissolved in an appropriate amount of pure water to obtain a solution;

[0035] b. Add 15g of silicon dioxide and 200g of ethyl cellulose to 180 ml of ethyl cellulose

[0036] alcohol and stir the mixture until a homogeneous dispersion is formed;

[0037] c. Mix the solution obtained in step a...

Embodiment 3

[0040] Embodiment 3: Prescription and preparation of ibuprofen arginine powder for children

[0041] Above-mentioned embodiment 2 sprays and obtains particle 2000g

[0042] Orange juice essence 30ml

[0043] Aspartame 25g

[0044] Packing into 1000 bags. Preparation method: Put the granules obtained by spraying in Example 2 on the fluidized bed, and spray the solution containing aspartame at 20-40°C to obtain ibuprofen arginine for children. Acid powder.

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PUM

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Abstract

The present invention provides a preparation method of granules containing ibuprofen arginine composite, and the described composite is formed from ibuprofen arginine, diluting agent and adhesive, and said preparation method includes two steps of granurating and coating, and uses the coating material containing silicon dioxide to make coating liquor, and uses the prepared coating liquor to coat the granules. Said granules can be tabletted, also cna be capsulized, and the conventional solid soage form prepared by using said method has good stability, quick disintegration speed and high biological utilization rate.

Description

(1) Technical field [0001] The invention relates to a method for preparing granules of an antipyretic and analgesic drug containing ibuprofen arginine composition. (2) Background technology [0002] The traditional antipyretic and analgesic ibuprofen is almost insoluble in water, and the pharmacokinetic parameter T max (The time to reach the maximum blood concentration) is 1.5-2h, and like other oral NSAIDs (non-steroidal anti-inflammatory drugs), the onset of action is relatively slow. The Zambon S.p.A. company of Italy solved this problem in 1986 according to the actual situation, and developed the salt of ibuprofen combined with arginine (CH673394): because of the combination of arginine, the water insolubility of ibuprofen is changed, and the absorption in the body The rate of increase, the time to reach the maximum plasma concentration (T max ) decreased, the maximum plasma concentration (C max ) increase, especially T max The value is reduced from 1.5-2 hours to ab...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/198A61P29/00
Inventor 胡雅芳
Owner SUNSTONE TANGSHAN PHARM CO LTD
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