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Silicified microcrystalline cellulose composite auxiliary material and preparation method thereof

A technology of microcrystalline cellulose and composite excipients, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, pill delivery, etc., which can solve the problem of uneven mixing of mixed materials and the inability to meet the requirements of direct powder compression, etc. problems, to achieve the effect of reducing friability, increasing hardness and smoothness, and increasing economic benefits

Inactive Publication Date: 2015-01-07
安徽山河药用辅料股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to overcome the inhomogeneous mixing of the mixed materials obtained by directly mixing silicon dioxide and microcrystalline cellulose, which cannot well meet the requirements of direct powder compression

Method used

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  • Silicified microcrystalline cellulose composite auxiliary material and preparation method thereof
  • Silicified microcrystalline cellulose composite auxiliary material and preparation method thereof
  • Silicified microcrystalline cellulose composite auxiliary material and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A kind of silicified microcrystalline cellulose composite auxiliary material of the present invention and preparation method thereof, its component and quality are as follows:

[0027] Weigh 25.2kg of microcrystalline cellulose, 0.5kg of silicon dioxide, 0.08kg of hypromellose K4M, and 74kg of water. Among them, microcrystalline cellulose, silicon dioxide, and hypromellose come from Anhui Shanhe Pharmaceutical Excipients Co., Ltd.

[0028] The preparation method of the silicified microcrystalline cellulose composite auxiliary material of the present embodiment, its preparation method is:

[0029] ① Mixing: After dissolving the hypromellose K4M and water in the above-mentioned weighed raw materials, put them into a U-shaped blender, put the weighed silicon dioxide into the blender, turn on the blender and stir for 10 minutes, and continue to Drop into the weighed microcrystalline cellulose and stir for 50 minutes to form a uniform suspension A;

[0030] ②Centrifugal sp...

Embodiment 2

[0036] A kind of silicified microcrystalline cellulose composite auxiliary material of the present invention and preparation method thereof, its component and quality are as follows:

[0037] Weigh 25.5kg of microcrystalline cellulose, 0.8kg of silicon dioxide, 0.08kg of hypromellose K4M, and 74kg of water.

[0038] The preparation method of the silicified microcrystalline cellulose composite auxiliary material of the present embodiment, its preparation method is:

[0039] ① Mixing: After dissolving the hypromellose K4M and water in the above-mentioned weighed raw materials, put them into a U-shaped blender, put the weighed silicon dioxide into the blender, turn on the blender and stir for 25 minutes, and continue to Drop into the weighed microcrystalline cellulose and stir for 40 minutes to form a uniform suspension A;

[0040] ②Centrifugal spray drying: Turn on the high-speed centrifugal spray dryer, set the air inlet temperature to 160 degrees, and the outlet temperature t...

Embodiment 3

[0046] A kind of silicified microcrystalline cellulose composite auxiliary material of the present invention and preparation method thereof, its component and quality are as follows:

[0047] Weigh 25.35kg of microcrystalline cellulose, 0.57kg of silicon dioxide, 0.08kg of hypromellose K4M, and 74kg of water.

[0048] The preparation method of the silicified microcrystalline cellulose composite auxiliary material of the present embodiment, its preparation method is:

[0049] ① Mixing: After dissolving the hypromellose K4M and water in the above-mentioned weighed raw materials, put them into a U-shaped blender, put the weighed silicon dioxide into the blender, turn on the blender and stir for 30 minutes, and continue to Drop into the weighed microcrystalline cellulose and stir for 60 minutes to form a uniform suspension A;

[0050] ②Centrifugal spray drying: Turn on the high-speed centrifugal spray dryer, set the air inlet temperature to 160 degrees, and the outlet temperature t...

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Abstract

The invention discloses a silicified microcrystalline cellulose composite auxiliary material and a preparation method thereof, belonging to the field of medical premixed composite auxiliary materials. The silicified microcrystalline cellulose composite auxiliary material disclosed by the invention consists of the following components in parts by mass: 25.2-25.5 parts of microcrystalline cellulose, 0.5-0.8 part of silicon dioxide, 0.08 part of hydroxypropyl methylcellulose K4M and 74 parts of water. The preparation method comprises the following steps: (1) dissolving the hydroxypropyl methylcellulose K4M and water, adding the dissolved substances into a stirrer, adding the silicon dioxide, stirring, adding the microcrystalline cellulose, and stirring, thereby obtaining uniform suspension A; (2) setting the air inlet temperature at 160 DEG C by using a centrifugal spray dryer, setting the outlet temperature at 95 DEG C, setting the rotating speed of an atomizer at 8000 revolutions per minute, setting the rotating speed of a peristaltic pump at 20 revolutions per minute, and drying, thereby obtaining a material B; (3) adding the material B into a screening machine, vibrating and screening to the granularity of 80 meshes, thereby obtaining sieve residues C; and (4) testing the samples of sieve residues C, thereby obtaining the product of which the quality accords with the regulation, namely the composite auxiliary material. According to the composite auxiliary material and the preparation method thereof provided by the invention, the requirement of directly pressing the powder is met, so that the product is uniform in tablet weight, large in tablet hardness, smooth in tablet and qualified in dissolution rate.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical premixed composite auxiliary materials, in particular to a silicified microcrystalline cellulose composite auxiliary material and a preparation method thereof. Background technique [0002] The first appearance of microcrystalline cellulose in 1963 fundamentally improved the flow properties of the powder and broke through the main technical bottleneck of the powder direct compression process, which is a milestone for the pharmaceutical industry. Because there are hydrogen bonds between the molecules of microcrystalline cellulose, hydrogen bonds are associated under pressure, so it has high compressibility and is often used as a binder; when the compressed tablet encounters liquid, water quickly enters the microcrystalline cellulose containing microcrystalline cellulose. Inside the tablet, the hydrogen bond of crystalline cellulose is broken immediately, so it can be used as a disintegrant. ...

Claims

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Application Information

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IPC IPC(8): A61K47/38A61K47/04A61K9/20
Inventor 徐玉勋毕勇叶永超武蛟任利亭朱岩陈晓雪
Owner 安徽山河药用辅料股份有限公司
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