Dexibuprofen enteric-coated and sustained-release tablet and preparation method thereof

A technology of dextro-ibuprofen and sustained-release tablets, which can be used in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc. and other problems, to achieve excellent sustained-release effect, eliminate irritation, and the effect of light and small tablets

Active Publication Date: 2016-01-20
湖北省医药工业研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patents CN102160855B and CN102293759A both involve dextroibuprofen sustained-release tablets and their preparation methods. The preparation of CN102160855B sustained-release tablets consists of quick-release parts, sustained-release parts and magnesium stearate; the preparation process of CN102293759A involves direct mixing of powders and tableting The preparation method of the process, obviously due to the poor fluidity of dextrobuprofen, the powder direct mi...

Method used

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  • Dexibuprofen enteric-coated and sustained-release tablet and preparation method thereof
  • Dexibuprofen enteric-coated and sustained-release tablet and preparation method thereof
  • Dexibuprofen enteric-coated and sustained-release tablet and preparation method thereof

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Embodiment 1

[0084] The preparation of embodiment 1 Dexibuprofen enteric-coated sustained-release tablets:

[0085] Tablet core prescription composition (g / 1000 tablets:

[0086] Dexibuprofen 300

[0087] Hydroxypropylmethylcellulose (HPMC)-K4M40

[0088] Hydroxypropyl Methyl Cellulose (HPMC)-K100LV20

[0089] Lactose 30

[0090] 75% ethanol solution Q.S

[0091] Micropowder silica gel 3

[0092] Magnesium Stearate 2

[0093] Enteric coating formula:

[0094] Acrylic resin (Eudragit® L30D-55) 160g

[0095] Triethyl citrate 4.8g

[0096] Glyceryl monostearate 2.4g

[0097] Tween-801.0g

[0098] 160g of water

[0099] 【Description of preparation process】

[0100] (1) Pass the prescription amount of Dexibuprofen through an 80-mesh sieve, and mix well with hypromellose (K4M), hypromellose (K100LV) and lactose;

[0101] (2) Add an appropriate amount of 75% ethanol to prepare soft materials, and pass through a 24-mesh sieve to obtain wet granules;

[0102] (3) Dry the wet g...

Embodiment 2

[0111] The preparation of embodiment 2 Dexibuprofen slow-release tablets

[0112] Tablet core prescription composition (g / 1000 tablets:

[0113] Dexibuprofen 300

[0114] Hydroxypropylmethylcellulose (HPMC)-K4M40

[0115] Hydroxypropyl Methyl Cellulose (HPMC)-K100LV20

[0116] Lactose 30

[0117] 75% ethanol solution Q.S

[0118] Micropowder silica gel 3

[0119] Magnesium Stearate 2

[0120] Enteric coating formula:

[0121] Acrylic resin (Eudragit® L30D-55) 160g

[0122] Triethyl citrate 4.8g

[0123] Glyceryl monostearate 2.4g

[0124] Tween-801.0g

[0125] 160g of water

[0126] 【Description of preparation process】

[0127] (1) Pass the prescription amount of Dexibuprofen through an 80-mesh sieve, and mix well with hypromellose (K4M), hypromellose (K100LV) and lactose;

[0128] (2) Add an appropriate amount of 75% ethanol to prepare soft materials, and pass through a 24-mesh sieve to obtain wet granules;

[0129] (3) Dry the wet granules in a blast dr...

Embodiment 3

[0135] The preparation of embodiment 3 Dexibuprofen slow-release tablets

[0136] Tablet core prescription composition (g / 1000 tablets):

[0137] Dexibuprofen 300

[0138] Hydroxypropylmethylcellulose (HPMC)-K4M45

[0139] Hydroxypropyl Methyl Cellulose (HPMC)-K100LV15

[0140] 85% ethanol solution Q.S

[0141] Micropowder silica gel 3

[0142] Magnesium Stearate 2

[0143] Coating formula:

[0144] Acrylic resin (Eudragit® L30D-55) 160g

[0145] Triethyl citrate 4.8g

[0146] Glyceryl monostearate 2.4g

[0147] Tween-801.0g

[0148] 160g of water

[0149] 【Description of preparation process】

[0150] (1) Pass the prescribed amount of Dexibuprofen through an 80-mesh sieve, and mix well with hypromellose (K4M) and hypromellose (K100LV);

[0151] (2) Add an appropriate amount of 85% ethanol to prepare soft materials, and pass through a 24-mesh sieve to obtain wet granules;

[0152] (3) Dry the wet granules in a blast drying oven at 45°C for 4 hours, and pass...

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Abstract

The invention relates to a dexibuprofen enteric-coated and sustained-release tablet. The dexibuprofen enteric-coated and sustained-release tablet comprises a tablet core with a sustained release effect and a coating for coating the table core, wherein the tablet core is prepared from the following components: 70-90 parts of dexibuprofen, 10-30 parts of sustained-release skeleton stabilizer, 0-10 parts of filler, 0.2-1.5 parts of lubricating agent and 0.2-1.5 parts of flow aid; the effective quantity of active ingredient dexibuprofen takes more than 70% of the weight of table core. The invention has the advantages of excellent formula, reliable preparation process and easiness in industrial production; the prepared enteric-coated and sustained-release tablet in-vitro dissolution experiment shows: the releasing rate of gastric juice in 2 hours is smaller than 10%, which meets the requirements; the releasing rate of intestinal juice in 2 hours is 25-55%, the accumulative releasing rate in 4 hours is 50-80%, the accumulative releasing rate in 8 hours is more than 80%, and therefore, the releasing effect is excellent. The dexibuprofen enteric-coated and sustained-release tablet has effects of undissolving in the stomach and slowly releasing in the intestines so as to prevent irritation to the stomach and prolong the in-vivo releasing time of medicines simultaneously; the dexibuprofen enteric-coated and sustained-release tablet facilitates absorption to human bodies and has lasting effects.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a dextroibuprofen enteric-coated sustained-release tablet and a preparation method thereof. Background technique [0002] Active ingredient: Dexibuprofen [0003] Chemical name: (2S)-2-[4-(2-methylpropyl)phenyl]propanoic acid [0004] English name: Dexibuprofen [0005] English chemical name: S(+)-2(4-isobutylphenyl) propionic acid [0006] Molecular formula: C 13 h 18 o 2 [0007] Molecular weight: 206.28 [0008] Structural formula: [0009] [0010] As a non-steroidal anti-inflammatory drug that has been used clinically for many years, ibuprofen has been fully confirmed in its safety and effectiveness. It produces antipyretic, analgesic and anti-inflammatory effects by inhibiting the synthesis of prostaglandins. For rheumatism and rheumatoid arthritis, it can also be used for general antipyretic and analgesic, and it is the first step drug i...

Claims

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Application Information

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IPC IPC(8): A61K9/32A61K9/36A61K31/192A61P29/00
Inventor 程天贵谢林肖志梅
Owner 湖北省医药工业研究院有限公司
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