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Novel pharmaceutical auxiliary material namely silicified microcrystalline cellulose and preparation method thereof

A technology of microcrystalline cellulose and pharmaceutical excipients, applied in pharmaceutical formulations, medical preparations of non-active ingredients, etc.

Inactive Publication Date: 2015-07-15
GUANGDONG GUOYUAN GUOYAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to overcome the shortcomings that the existing microcrystalline cellulose in China cannot fully meet the requirements of the existing powder direct compression and traditional Chinese medicine dispersion preparations.

Method used

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  • Novel pharmaceutical auxiliary material namely silicified microcrystalline cellulose and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Components:

[0020] Material name

Proportion(%)

Weight (g)

microcrystalline cellulose

98.15

9815

Micropowder silica gel

1.85

185

[0021] Preparation:

[0022] (1) take by weighing microcrystalline cellulose 9815g and micropowder silica gel 185g of recipe quantity, standby;

[0023] (2) Pass 9815g of microcrystalline cellulose and 154.17g of micropowder silica gel through an 80-mesh sieve for 3 times, add into purified water, stir evenly, and prepare a solution with a solid content of 0.5%, and set aside;

[0024] (3) Add the solution in (2) to the high-shear dispersing homogenizer, set the linear speed to 30m / s, treat it 7 times, and set aside; (4) Add 30.83g of micropowder silica gel to the solution in (3), and stir Evenly, add to the high-shear dispersing homogenizer, set the line speed to 15m / s, process twice, and set aside;

[0025] (5) Put the solution in (4) in the spray dryer, set the air inlet temperat...

Embodiment 2

[0027] Components:

[0028] Material name

Proportion(%)

Weight (g)

microcrystalline cellulose

99.45

9945

Micropowder silica gel

0.55

55

[0029] Preparation:

[0030] (1) microcrystalline cellulose 9945g and micropowder silica gel 55g of prescription quantity are taken by weighing, for subsequent use;

[0031] (2) Pass 9945g of microcrystalline cellulose and 45.83g of micropowder silica gel through an 80-mesh sieve for 3 times, add into purified water, stir evenly, and prepare a solution with a solid content of 4.8% for subsequent use;

[0032] (3) Add the solution in (2) to the high-shear dispersing homogenizer, set the linear velocity to 65m / s, process 5 times, and set aside;

[0033] (4) Add 9.17g of micropowder silica gel to the solution in (3), stir evenly, add it to a high-shear dispersing homogenizer, set the line speed to 18m / s, process 3 times, and set aside;

[0034] (5) Put the solution in (4) in the spray d...

Embodiment 3

[0036] Components:

[0037] Material name

Proportion(%)

Weight (g)

microcrystalline cellulose

99.02

9902

Micropowder silica gel

0.98

98

[0038] Preparation:

[0039] (1) take microcrystalline cellulose 9902g and micropowder silica gel 98g of recipe quantity, standby;

[0040] (2) Pass 9902g of microcrystalline cellulose and 81.67g of micropowder silica gel through an 80-mesh sieve for 3 times, add to purified water, stir evenly, prepare a solution with a solid content of 3.1%, and set aside;

[0041] (3) Add the solution in (2) to a high-shear dispersing homogenizer, set the linear velocity to 50m / s, process it twice, and set aside;

[0042] (4) Add 16.33g of micropowder silica gel into the solution in (3), stir evenly, add it into a high-shear dispersing homogenizer, set the line speed to 22m / s, process it twice, and set aside;

[0043] (5) Put the solution in (4) in the spray dryer, set the inlet air temperature to ...

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Abstract

A novel pharmaceutical auxiliary material namely silicified microcrystalline cellulose and a preparation method thereof are disclosed. The preparation method comprises the following steps: preparing microcrystalline cellulose accounting for 98.15 to 99.45% of the total weight of raw materials and aerosil accounting for 0.55 to 1.85% of the total weight of raw materials, mixing microcrystalline cellulose with part of aerosil, processing the mixture by a high-speed shearing, dispersing, and homogenizing machine, adding the residual aerosil into the homogenized emulsion, evenly mixing, and carrying out spray-drying to prepare the silicified microcrystalline cellulose. The prepared silicified microcrystalline cellulose has good fluidity and compressibility, moreover the preparation properties such as disintegration property, dispersion uniformity, dissolution rate, and the like are effectively improved, and thus the silicified microcrystalline cellulose is especially suitable for the production of traditional Chinese medicine dispersible preparations. The silicified microcrystalline cellulose is used to prepare Fuyankang dispersible tablets, and the appearance, dispersion uniformity, and dissolution degree of the tablets are all effectively improved.

Description

technical field [0001] The invention relates to an innovative pharmaceutical auxiliary material, silicified microcrystalline cellulose, namely silicified microcrystalline cellulose and a preparation method thereof. Background technique [0002] Microcrystalline cellulose (MCC) is an extremely fine white short rod-shaped or amorphous crystalline powder obtained by hydrolyzing natural cellulose with dilute inorganic acid to reach the limit degree of polymerization. It is odorless and tasteless. The particle size is generally 20-80 microns, and the limiting degree of polymerization (LODP) is 15-375; it is not fibrous and has strong fluidity. Insoluble in water, dilute acids, organic solvents and oils, partially soluble and swelling in dilute alkali solutions, and has high reactivity in the process of carboxymethylation, acetylation and esterification. Due to its special properties such as low degree of polymerization and large specific surface area, microcrystalline cellulose ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/38A61K47/04
Inventor 张晓薇郭彧张凯谢雁鸣欧石军刘华亮艾风伍彪
Owner GUANGDONG GUOYUAN GUOYAO PHARMA CO LTD
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