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Dexibuprofen particle and preparation method thereof

A granule and sodium carbonate technology, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of long time required for low-temperature drying, unqualified microbial limits, and difficult moisture control and other problems, to achieve the effect of stable and controllable quality, suitable for industrial production, and easy control of microorganisms

Active Publication Date: 2010-09-15
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the fusing point of Dexibuprofen is low, it is 48 ℃~52 ℃, this method adopts low-temperature drying to prepare Dexibuprofen granule, and the temperature of its low-temperature drying is 35 ℃~40 ℃, and this temperature is more suitable for microbial growth, causes The microbial limit of the product is unqualified, and it takes a long time to dry at low temperature. Not only the moisture content of the product is not easy to control, the quality cannot be guaranteed, but also the cost is high

Method used

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  • Dexibuprofen particle and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Pass the dextrobuprofen, sodium carbonate, and aspartam through 80-mesh sieves respectively, and sucrose after crushing and pass through 80-mesh sieves for later use.

[0043] Weigh the raw materials of the following prescription quantities:

[0044] Dexibuprofen 200g

[0045] Sodium carbonate 200g

[0046] Sucrose 2480g

[0047] Aspartame 60g

[0048] 75% ethanol 860g

[0049] Lychee essence 10g.

[0050] Fully mix aspartam, dextrobuprofen, and sodium carbonate to obtain a mixture. Divide sucrose into 3 parts of equal weight, add the above mixture in 3 times, mix for 10 minutes after each addition, and mix well. Finally, add 75% ethanol to make soft material, use 20 mesh sieve to granulate, blow dry at 60°C for 2 hours, spray lychee essence, mix, and obtain dextroibuprofen granules after 18 mesh sieve granulation, intermediate After passing the inspection, use aluminum-plastic composite bags to pack into 14600 bags according to 200mg / bag, and pack to get the fini...

Embodiment 2

[0052] Pass the dextrobuprofen, sodium carbonate, and aspartam through 80-mesh sieves respectively, and sucrose after crushing and pass through 80-mesh sieves for later use.

[0053] Weigh the raw materials of the following prescription quantities:

[0054] Dexibuprofen 100g

[0055] Sodium carbonate 300g

[0056] Sucrose 2360g

[0057] Aspartame 14g

[0058] 75% ethanol 460g

[0059] Orange essence 5g.

[0060] Fully mix aspartam, dextrobuprofen, and sodium carbonate to obtain a mixture. Divide sucrose into 3 parts of equal weight, add the above mixture in 3 times, mix for 10 minutes after each addition, and mix well. Finally, add 75% ethanol to make a soft material, use 20 mesh sieve to granulate, then blow dry at 70°C for 1.5h, spray into orange essence, and mix them all. After passing the intermediate inspection, use aluminum-plastic composite bags to divide into 13480 bags according to 200 mg / bag, and pack to obtain the finished product.

Embodiment 3

[0062] Pass the dextrobuprofen, sodium carbonate, and aspartam through 80-mesh sieves respectively, and sucrose after crushing and pass through 80-mesh sieves for later use.

[0063] Weigh the raw materials of the following prescription quantities:

[0064] Dexibuprofen 400g

[0065] Sodium carbonate 500g

[0066] Sucrose 4360g

[0067] Aspartame 60g

[0068] 75% ethanol 1300g

[0069] Green Apple Flavor 20g.

[0070] Fully mix aspartam, dextrobuprofen, and sodium carbonate to obtain a mixture. Divide sucrose into 3 parts of equal weight, add the above mixture in 3 times, mix for 10 minutes after each addition, and mix well. Finally, add 75% ethanol to make a soft material, use a 20-mesh sieve to granulate, and then dry it by air at 80°C for 1 hour. After passing the physical examination, use aluminum-plastic composite bags to pack into 25280 bags according to 200 mg / bag, and pack to get the finished product.

[0071] The Dexibuprofen granule that embodiment 1~3 is made...

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Abstract

The invention discloses a dexibuprofen particle which is mainly prepared from the following raw materials in parts by weight: 1-10 parts of dexibuprofen, 1-6 parts of sodium carbonate, 1-35 parts of sucrose, 0.1-0.8 part of aspartame and 3-12 parts of ethanol. The invention also discloses a preparation method of the dexibuprofen particle, which comprises the following steps of: sieving each raw material, and then, fully mixing the raw materials uniformly; granulating; and drying at high temperature, and then, refining to obtain the dexibuprofen particle. The dexibuprofen particle of the invention can endure high-temperature drying, has qualified indexes of microbial limit, solubility and the like and has stable and controllable quality; in addition, the preparation method is simple to operate has short production cycle and low cost, and is suitable for industrialized production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dextrobuprofen granule and a preparation method thereof. Background technique [0002] Ibuprofen is a propionic acid non-steroidal anti-inflammatory drug with analgesic, anti-inflammatory and antipyretic effects. Congestion and swelling of the tissues in the body can reduce the sensitivity of peripheral nerve pain. It acts as an antipyretic through the hypothalamic thermoregulatory center. [0003] Although ibuprofen is a commonly used non-steroidal anti-inflammatory drug at present, its wide application is affected due to reasons such as large oral dose, poor taste and gastrointestinal irritation. In recent years, there have been many clinical adverse reactions of ibuprofen, such as anaphylaxis, anaphylactic shock, lower extremity edema, nausea, vomiting, indigestion and so on. Clinically, the application of mixed ibuprofen instead of ibuprofen has also been adopte...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/192A61K47/26A61P29/00
Inventor 刘全国
Owner HAINAN HULUWA PHARMA GRP CO LTD
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