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A kind of direct compression tablet composite auxiliary material and preparation method thereof

A tableting, direct technology, used in pharmaceutical formulations, medical preparations with non-active ingredients, pill delivery, etc., can solve the problems of unstable dissolution, decreased fluidity, uneven mixing, etc., to achieve no chemical reaction changes, production The effect of reducing energy consumption and overcoming uneven particle size

Active Publication Date: 2017-10-24
ANHUI SUNHERE PHARMA EXCIPIENTS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are still some problems in tableting after mixing these direct tableting excipients, such as inhomogeneous mixing, particle damage if the mixing time is too long, decreased fluidity, large difference in tablet weight, over-lubrication effect, loose tablet after tableting , and the dissolution is not stable

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] A direct compression composite auxiliary material is composed of the following raw materials in parts by weight ratio: 25 parts of microcrystalline cellulose, 4 parts of lactose monohydrate, 3 parts of pregelatinized starch, 0.8 parts of sodium stearyl fumarate, and colloidal dioxide 5 parts of silicon, 0.2 parts of sodium lauryl sulfate, and 62 parts of water.

[0016] The specific preparation method is:

[0017] ①Powder sieve: at room temperature, microcrystalline cellulose, lactose monohydrate, pregelatinized starch, colloidal silicon dioxide are passed through a 100 mesh thickened vibrating sieve;

[0018] ②Emulsification: At room temperature, weigh the required amount of the above-mentioned raw materials according to the formula, and put them into the mixing tank, turn on the mixing for 30 minutes, and transfer to the high-speed shearing machine after mixing. After mixing for 30 minutes, a uniform white color can be formed Milky suspension;

[0019] ③Spray: Turn on the po...

Embodiment 2

[0022] A direct compression composite auxiliary material is composed of the following raw materials in parts by weight ratio: 35 parts of microcrystalline cellulose, 9 parts of lactose monohydrate, 5 parts of pregelatinized starch, 1 part of sodium stearyl fumarate, and colloidal dioxide 6 parts of silicon, 0.5 parts of sodium lauryl sulfate, 43.5 parts of water.

[0023] The specific preparation method is:

[0024] ①Powder sieve: at room temperature, microcrystalline cellulose, lactose monohydrate, pregelatinized starch, colloidal silicon dioxide are passed through a 100 mesh thickened vibrating sieve;

[0025] ②Mixing: At room temperature, weigh the required amount of the above-mentioned raw materials according to the formula, and put them into the mixing tank, turn on the mixing for 40 minutes, and transfer to the high-speed shearing machine after mixing. After mixing for 40 minutes, a uniform white color can be formed Milky suspension;

[0026] ③Spray: turn on the power switch an...

Embodiment 3

[0029] A direct compression composite auxiliary material is composed of the following raw materials in parts by weight ratio: 30 parts of microcrystalline cellulose, 6 parts of lactose monohydrate, 5 parts of pregelatinized starch, 0.8 parts of sodium stearyl fumarate, and colloidal dioxide 5 parts of silicon, 0.2 parts of sodium lauryl sulfate, and 53 parts of water.

[0030] The specific preparation method is:

[0031] ①Powder sieve: at room temperature, microcrystalline cellulose, lactose monohydrate, pregelatinized starch, colloidal silicon dioxide are passed through a 100 mesh thickened vibrating sieve;

[0032] ②Mixing: At room temperature, weigh the required amount of the above-mentioned raw materials according to the formula, and put them into the mixing tank, turn on the mixing for 20 minutes, and transfer to the high-speed shearing machine after mixing. After mixing for 20 minutes, a uniform white color can be formed Milky suspension;

[0033] ③Spray: Turn on the power swit...

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PUM

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Abstract

The invention discloses a composite auxiliary material for direct compression, which mainly consists of raw materials in parts by weight: 25-35 parts of microcrystalline cellulose, 4-9 parts of lactose monohydrate, 3-5 parts of pregelatinized starch, stearin rich 0.8-1 part of sodium maleate, 5-6 parts of colloidal silicon dioxide, 0.2-0.5 part of sodium lauryl sulfate, and 50-70 parts of water are prepared through the process steps of pulverization, emulsification, spraying and granulation. The invention also discloses a preparation method of the direct tableting compound auxiliary material. The present invention improves the process adaptability of the direct tableting auxiliary material, and reduces the production energy consumption by 1-2 times compared with the production of a single direct tableting auxiliary material; overcomes the non-uniform particle size, easy occurrence in the mixing process of different types of direct tableting auxiliary materials, Stratification, dissolution instability, over-lubrication effect, etc.

Description

Technical field [0001] The invention relates to a composite auxiliary material, in particular to a direct compression composite auxiliary material and a preparation method thereof, and belongs to the field of chemical pharmacy. Background technique [0002] At present, although wet granule compression is still the most widely used tablet production in my country, the application of powder direct compression technology in domestic and foreign pharmaceutical companies is gradually attracting attention and has a rapid development. Direct powder compression has obvious advantages over wet granulation and compression: 1. It reduces the cost of equipment and operation, and its production process is simple, without the need for granulation, sieving, drying, granulation, and intermediate sampling and testing. It reduces the corresponding equipment plant investment, inspection cost and labor intensity, and saves time and energy. 2. Avoid the influence of heating and moisture. In actual ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/38A61K47/36A61K47/26A61K47/04A61K47/20A61K47/12A61K9/20
Inventor 毕勇余伟尹正龙李杰徐玉勋朱岩刘强武蛟夏叶青陈晓雪叶永超任利亭
Owner ANHUI SUNHERE PHARMA EXCIPIENTS
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