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 direct

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

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Example Embodiment

[0025] Example 1

[0026] The silicified microcrystalline cellulose composite auxiliary material of the present invention and its preparation method have the following components and quality:

[0027] Weigh 25.2 kg of microcrystalline cellulose, 0.5 kg of silicon dioxide, 0.08 kg of hypromellose K4M, and 74 kg 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 this embodiment is as follows:

[0029] ①Mixing: After dissolving the hypromellose K4M and water in the above weighed raw materials, put them into a U-shaped mixer, and put the weighed silica into the mixer, turn on the mixer and stir for 10 minutes, and continue after mixing evenly. Add the weighed microcrystalline cellulose and stir for 50 minutes to form a uniform suspension A;

[0030] ② Centrifugal spray drying: turn on the hi...

Example Embodiment

[0035] Example 2

[0036] The silicified microcrystalline cellulose composite auxiliary material of the present invention and its preparation method have the following components and quality:

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

[0038] The preparation method of the silicified microcrystalline cellulose composite auxiliary material of this embodiment is as follows:

[0039] ①Mixing: After dissolving the hypromellose K4M and water in the above weighed raw materials, put them in a U-shaped mixer, and put the weighed silica into the mixer, turn on the mixer and mix for 25 minutes, and continue after mixing evenly. Add the weighed microcrystalline cellulose and stir for 40 minutes to form a uniform suspension A;

[0040] ② Centrifugal spray drying: Turn on the high-speed centrifugal spray dryer, set the inlet air temperature to 160 degrees, and the outlet temperature to 95 degrees. The feed pipe i...

Example Embodiment

[0045] Example 3

[0046] The silicified microcrystalline cellulose composite auxiliary material of the present invention and its preparation method have the following components and quality:

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

[0048] The preparation method of the silicified microcrystalline cellulose composite auxiliary material of this embodiment is as follows:

[0049] ①Mixing: After dissolving the hypromellose K4M and water in the above weighed raw materials, put them into a U-shaped mixer, and put the weighed silica into the mixer, turn on the mixer and mix for 30 minutes, and continue after mixing evenly Add the weighed microcrystalline cellulose and stir for 60 minutes to form a uniform suspension A;

[0050] ② Centrifugal spray drying: Turn on the high-speed centrifugal spray dryer, set the inlet air temperature to 160 degrees, and the outlet temperature to 95 degrees. The feed pip...

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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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