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Indobufen pharmaceutical composition

A technology of indobufen and its composition, which is applied in the field of medicine, can solve problems such as poor fluidity and poor granulation effect, and achieve the effects of improving dissolution rate, increasing bulk density, and improving fluidity

Pending Publication Date: 2022-07-01
HANGZHOU ZHONGMEI HUADONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the defects in the prior art, this aspect provides a new indobufen tablet pharmaceutical composition, which solves the problems of poor granulation effect and poor fluidity

Method used

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  • Indobufen pharmaceutical composition
  • Indobufen pharmaceutical composition
  • Indobufen pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Indobufen 200g

[0033] Lactose monohydrate 210.4g

[0034] Microcrystalline Cellulose 78.78g

[0035] Sodium Carboxymethyl Starch 26.3g

[0036] Magnesium Lauryl Sulfate 5.26g

[0037] Magnesium Stearate 5.26g

[0038] 1) Pre-mixing: Weigh the raw and auxiliary materials of the recipe and mix them in wet granulation for 3 minutes. The stirring speed of the wet granulator is 5r / s and the shearing speed is 20r / s;

[0039] 2) Granulation: add water to make soft materials respectively, the amount of water is 10%, 24%, 40% respectively, the stirring speed of the wet granulator is 5r / s, the shearing speed is 20r / s; grain;

[0040] 3) Drying; drying the wet granules in an oven (60°C);

[0041] 4) Granulation: dry granules are granulated through a 1.5mm screen;

[0042] 5) total mixing: add the magnesium stearate of recipe quantity and carry out total mixing;

[0043] 6) Compression: Press the theoretical tablet to recompress the tablet, and the dissolution data result...

Embodiment 2

[0048] Indobufen 200g

[0049] Lactose monohydrate 210.4g

[0050] Microcrystalline Cellulose 78.78g

[0051] Sodium Carboxymethyl Starch 26.3g

[0052] Sodium Lauryl Sulfate 5.26g

[0053] Magnesium Stearate 5.26g

[0054] 1) Pre-mixing: Weigh the raw and auxiliary materials of the recipe and mix them in wet granulation for 3 minutes. The stirring speed of the wet granulator is 5r / s and the shearing speed is 20r / s;

[0055] 2) Granulation: add water to make soft material, the amount of water is 24%, the stirring speed of the wet granulator is 5r / s, the shearing speed is 20r / s; the soft material is granulated through a 1.5mm screen;

[0056] 3) Drying; drying the wet granules in an oven (60°C);

[0057] 4) Granulation: dry granules are granulated through a 1.5mm screen;

[0058] 5) total mixing: add the magnesium stearate of recipe quantity and carry out total mixing;

[0059] 6) Compression: Press the theoretical tablet to recompress the tablet, the dissolution data re...

Embodiment 3

[0061] Indobufen 200g

[0062] Lactose monohydrate 210.4g

[0063]Microcrystalline Cellulose 78.78g

[0064] Sodium Carboxymethyl Starch 26.3g

[0065] Sodium Lauryl Sulfate 10g

[0066] Magnesium Stearate 5.26g

[0067] 1) Pre-mixing: Weigh the raw and auxiliary materials in the formulation and mix them in wet granulation for 3 minutes. The wet granulator has a stirring speed of 5r / s and a shearing speed of 20r / s;

[0068] 2) Granulation: add water to make soft material, the amount of water is 24%, the stirring speed of the wet granulator is 5r / s, the shearing speed is 20r / s; the soft material is granulated through a 1.5mm screen;

[0069] 3) Drying; drying the wet granules in an oven (60°C);

[0070] 4) Granulation: dry granules are granulated through a 1.5mm screen;

[0071] 5) total mixing: add the magnesium stearate of recipe quantity and carry out total mixing;

[0072] 6) Tablet compression: Press the theoretical tablet to recompress the tablet, the dissolution d...

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Abstract

According to the indobufen pharmaceutical composition disclosed by the invention, the use of an adhesive disclosed in the prior art is avoided in a formula, and lauryl sodium sulfate or lauryl magnesium sulfate is added, so that the bulk density and tap density of powder are improved, the fluidity is favorably improved, and the particle size of indobufen is controlled to be below 100 meshes; and the dissolution rate of the product is improved and reaches 95.8%.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an indobufen pharmaceutical composition and a preparation method thereof. Background technique [0002] Indobufen, an isoindolinyl phenylbutyric acid derivative, is an inhibitor of platelet aggregation. It is currently the only reversible, selective multi-target antithrombotic drug. The comprehensive inhibition of various links and multiple targets can effectively block the formation of thrombosis, so as to achieve fast and high efficiency. Safely prevent ischemic cardiovascular disease, cerebrovascular disease, venous thrombosis caused by arteriosclerosis, and prevent thrombosis during hemodialysis. This product mainly exerts its anti-platelet aggregation effect through the following mechanisms: [0003] (1) Reversible inhibition of platelet cyclooxygenase reduces the production of thromboxane A2 (a potent activator of platelet aggregation); [0004] (2) Inhibit ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/404A61K9/20A61K47/20A61P7/02A61P9/10A61P3/06A61P9/14A61P3/10
CPCA61K31/404A61K9/2013A61K9/2077A61P7/02A61P9/10A61P3/06A61P9/14A61P3/10Y02A50/30
Inventor 方洁王建军傅立峰雷伯开施海斌方红梨王娟张霞
Owner HANGZHOU ZHONGMEI HUADONG PHARMA
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