Dexibuprofen pharmaceutical composition with improved dissolving out capability and method for preparing the same

The technology of a composition and a pharmaceutical preparation is applied in the field of dexibuprofen pharmaceutical composition and its preparation, which can solve the problems of slow dissolution of dexibuprofen, reduce gastrointestinal ulcer bleeding and improve plasma bioavailability , the effect of reducing adverse reactions

Inactive Publication Date: 2008-07-16
海南高升医药科技开发股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to provide a kind of Dexibuprofen composition and preparation method thereof, solve the problem that Dexibuprofen dissolves slowly in the gastrointesti

Method used

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  • Dexibuprofen pharmaceutical composition with improved dissolving out capability and method for preparing the same
  • Dexibuprofen pharmaceutical composition with improved dissolving out capability and method for preparing the same
  • Dexibuprofen pharmaceutical composition with improved dissolving out capability and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment 1 Preparation of Dexibuprofen pharmaceutical composition improving dissolution performance of the present invention

[0057] 1. Prescription A (tablet)

[0058] 1. Raw material - Dexibuprofen 150.0g

[0059] 2. Solubilizing compound - sodium carbonate 75.0g

[0060] 3. Thinner - starch 20.0g

[0061] Dry starch 12.0g (pre-dried at 100℃~105℃)

[0062] 3. Adhesive - 10% starch slurry 12.0g

[0063] 4. Lubricant—magnesium stearate 1.2g

[0064]A total of 1000 tablets were produced, specification: 150mg (calculated as Dexibuprofen)

[0065] 2. Preparation method

[0066] The first step: pass the dextrobuprofen and sodium carbonate through a 80-mesh sieve respectively, mix them with starch,

[0067] Step 2: Add starch slurry to make soft material, granulate with a 14-mesh sieve, dry at 40°C-50°C, granulate at 12-mesh, add dry starch and magnesium stearate, mix well, and set aside.

[0068] The third step: the obtained material is tested by the ...

Embodiment 2

[0069] Embodiment 2 Preparation of Dexibuprofen pharmaceutical composition improving dissolution performance of the present invention

[0070] 1. Prescription B (orally disintegrating tablets)

[0071] 1. Raw material - Dexibuprofen 150.0g

[0072] 2. Solubilizing compound - arginine 122.0g

[0073] 3. Diluent - Mannitol 30.0g

[0074] 4. Disintegrant—cross-linked polyvinylpyrrolidone (PVPP) 50.0g

[0075] Microcrystalline Cellulose 28.0g

[0076] 5. Flavoring agent - Stevia 20.0g

[0077] Citric acid 10.0g

[0078] 6. Lubricant—magnesium stearate 2.0g

[0079] A total of 1000 tablets were produced, specification: 150mg (calculated as Dexibuprofen)

[0080] 2. Preparation method

[0081] The first step: pass the dextrobuprofen and auxiliary materials through a 100-mesh sieve respectively, and take by weighing.

[0082] Step 2: Take Dexibuprofen, mannitol, microcrystalline cellulose, citric acid and 2 / 3 prescription amount of cross-linked polyvi...

Embodiment 3

[0085] Embodiment 3 Preparation of Dexibuprofen Pharmaceutical Composition with Improved Dissolution Performance of the Present Invention

[0086] 1. Prescription C (capsule)

[0087] 1. Raw material - Dexibuprofen 150.0g

[0088] 2. Solubilizing compound - sodium carbonate 50.0g

[0089] Sodium bicarbonate 30.0g

[0090] 3. Thinner - starch 30.0g

[0091] Dry starch 12.0g (pre-dried at 100℃~105℃)

[0092] 4. Lubricant—magnesium stearate 1.5g

[0093] A total of 1000 tablets were produced, specification: 150mg (calculated as Dexibuprofen)

[0094] 2. Preparation method

[0095] The first step: pass the dextrobuprofen and auxiliary materials through a 60-mesh sieve respectively, and take by weighing.

[0096] Step 2: Mix well and set aside.

[0097] The fourth step: the obtained material is tested by the intermediate, and after the filling amount is determined, it is packed into capsules.

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Abstract

The invention provides a dexibuprofen medical composition that can improve dissolution and a preparation method thereof, relating to the method technology field that improves the dissolution rate of the dexibuprofen medical compositions which comprise amino acid, sodium carbonate and sodium bicarbonate, being added with proper amount of other pharmaceutic adjuvant to form a new dexibuprofen medical composition. The dexibuprofen medical composition added with solubilization composition can be dissolved quickly in vivo and in vitro to shorten the absorption time and to improve the bioavailability of the blood plasma, thus resisting disease more quickly and effectively.

Description

technical field [0001] The invention provides a dexibuprofen pharmaceutical composition with improved dissolution performance and a preparation method thereof, and relates to the technical field of methods for improving the dissolution rate of dexibuprofen medicine. Background technique [0002] Dexibuprofen is the S-(+)-isomer of the widely used non-steroidal anti-inflammatory drug ibuprofen (racemate), which was launched in Austria in 1994. It is a non-steroidal antipyretic and analgesic drug, mainly used for the treatment of fever and pain induced by acute upper respiratory tract infection in children, acute pharyngitis and other diseases, various types of rheumatoid arthritis, rheumatoid arthritis, gout, various muscle injury pains, Acute mild to moderate pain, fever, etc. [0003] Studies have shown that there are great differences in the efficacy of ibuprofen chiral enantiomers, and the activity of dextroibuprofen is 160 times that of L-isomer and 1.6 times that of ra...

Claims

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Application Information

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IPC IPC(8): A61K31/192A61K47/16A61K47/02A61P29/00A61P19/02A61P11/04
Inventor 王小树杨贵方
Owner 海南高升医药科技开发股份有限公司
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