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Nimesulide medicine composition for improving dissolution performance and preparation method thereof

A composition and drug technology, applied in the field of nimesulide pharmaceutical composition and its preparation for improving dissolution performance, can solve the problems of difficult supply, expensive equipment, high manufacturing cost, etc., and achieve improved bioavailability and great application value Effect

Active Publication Date: 2012-09-05
HAINAN HONZ PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The above method accelerates and increases the dissolution of poorly soluble drugs and improves their bioavailability, but it is still not ideal
The preparation of nanoparticles requires special equipment such as a jet mill, which is expensive and has a lot of loss of materials during processing, so the manufacturing cost is relatively high; the method of reducing the dose of nimesulide also has some defects, such as taking The therapeutic effect can only be achieved by increasing the dosage; in the method of adding bioavailability enhancers such as piperine, piperine is not a commonly used pharmaceutical excipient, and there are certain difficulties in supply

Method used

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  • Nimesulide medicine composition for improving dissolution performance and preparation method thereof
  • Nimesulide medicine composition for improving dissolution performance and preparation method thereof
  • Nimesulide medicine composition for improving dissolution performance and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Embodiment 1: granule (making 1000 bags)

[0059] Ingredients Quantity / bag (g)

[0060] Nimesulide 50

[0061] PEG400 250

[0062] Microcrystalline Cellulose 1000

[0063] Silica 50

[0064] Sodium starch glycolate 71

[0065] Hypromellose 19.5

[0066] 65% ethanol appropriate amount (disappears during processing)

[0067] method:

[0068] (1) Add nimesulide into PEG400, stir and mix;

[0069] (2) Pass microcrystalline cellulose and silicon dioxide through an 80-mesh sieve, and mix well; add the mixture of step 1), and mix well;

[0070] (3) add sodium starch glycolate, mix;

[0071] (4) prepare 2% hypromellose ethanol solution with 60% ethanol as binder;

[0072] (5) wet granulation of the mixture of step 3) with the binder of step 4);

[0073] (6) The granules prepared in step 5) were dried at 65°C.

Embodiment 2

[0074] Embodiment 2: granules (1000 bags)

[0075] Ingredients Quantity / bag (g)

[0076] Nimesulide 50

[0077] PEG300 100

[0078] Microcrystalline Cellulose 500

[0079] Silica 25

[0080] Sodium starch glycolate 40

[0081] Hypromellose 14.5

[0082] 60% ethanol appropriate amount (disappears during processing)

[0083] method:

[0084] 1) Add nimesulide into PEG400, stir and mix;

[0085] 2) Pass the microcrystalline cellulose and silicon dioxide through an 80-mesh sieve, and mix well; add the mixture in step 1), and mix well;

[0086] 3) Add sodium starch glycolate and mix well;

[0087] 4) Prepare 2% hypromellose ethanol solution with 60% ethanol as binder;

[0088] 5) wet granulating the mixture of step 3) with the binder of step 4);

[0089] 6) The granules produced in step 5) are dried at 65°C.

Embodiment 3

[0090] Embodiment 3: granule (making 1000 bags)

[0091] Ingredients Quantity / bag (g)

[0092] Nimesulide 50

[0093] PEG200 100

[0094] Lactose 1000

[0095] Silica 50

[0096] Sodium starch glycolate 63

[0097] Hypromellose 8.1

[0098] 60% ethanol appropriate amount (disappears during processing)

[0099] method:

[0100] 1) Add nimesulide into PEG400, stir and mix;

[0101] 2) Pass lactose and silicon dioxide through an 80-mesh sieve, and mix well; add the mixture in step 1), and mix well;

[0102] 3) Add sodium starch glycolate and mix well;

[0103] 4) Prepare 2% hypromellose ethanol solution with 60% ethanol as binder;

[0104] 5) wet granulating the mixture of step 3) with the binder of step 4);

[0105] 6) The granules produced in step 5) are dried at 65°C.

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Abstract

The invention provides a nimesulide medicine composition for improving dissolution performance and a preparation method thereof. The medicine composition in the invention comprises the following components in weight percentage: 1%-30% of nimesulide, 5%-30% of dispersing agent (at least one kind of liquid polyethylene glycol), 60%-85% of diluent (one or more of microcrystalline cellulose, lactose and starch), 1%-10% of silicon dioxide, 2%-20% of disintegrating agents (carboxymethyl starch sodium) and 0.1%-5.0% of adhesives (hydroxypropyl methylcellulose). The dissolution degree of the nimesulide medicine composition can reach above 90% within 5-10 minutes, and even 100%, thus the nimesulide medicine composition is different from the conventional solid composition of various medicines; and the nimesulide medicine composition improves the bioavailability of the nimesulide, is beneficial to clinical rapid fever abatement or pain killing and has high application value.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a nimesulide pharmaceutical composition with improved dissolution performance and a preparation method thereof. Background technique [0002] The normal body temperature of the human body is usually controlled between 36.4°C and 36.9°C. Dysregulation of body temperature can lead to hypothermia or hyperthermia, both of which may lead to discomfort, including various diseases caused by the disorder of the body, or have serious consequences such as death. [0003] The most common form of hyperthermia is fever. Fever may be intermittent, characterized by daily high peaks followed by a return to normal temperature, or it may be intermittent, with body temperature not reaching normal levels. Fever may result from infection (eg, viral, bacterial, or fungal infection) or indirectly from various noninfectious conditions (eg, inflammation, tumor, or immunodeficiency). [0004] Fever caused...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/18A61K47/34A61K47/38A61K47/26A61K47/36A61P29/00A61K47/10
Inventor 洪江游洪丽萍王稳奇凌日金
Owner HAINAN HONZ PHARMA