Innovative drug excipient compressible sucrose and preparation method thereof

A technology of pharmaceutical excipients and sucrose, which is applied in the field of compressible sucrose and its preparation, and can solve problems affecting taste

Inactive Publication Date: 2015-12-16
GUANGDONG GUOYUAN GUOYAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to overcome the shortcomings that the existing domestic sucrose, dextrin, starch and compressible sucrose cannot fully meet the needs of modern preparations, and at the same time overcome the need to invest in large-scale equipment, high-temperature reflux and other equipment processes in the existing preparation process, and the preparation process is easy. The shortcoming of coking affecting the taste, using reasonable formula and low temperature preparation, the compressible sucrose produced has good fluidity and compressibility, high drug tolerance, fast dissolution, retains the color, aroma and taste of sucrose and improves the chewing feeling

Method used

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  • Innovative drug excipient compressible sucrose and preparation method thereof
  • Innovative drug excipient compressible sucrose and preparation method thereof
  • Innovative drug excipient compressible sucrose and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Components:

[0013] Material name

Proportion(%)

Weight (g)

sucrose

79.8

7980

Dextrin

3.7

370

starch

14.0

1400

silica

2.5

250

[0014] Preparation:

[0015] (1) take by weighing 7980g sucrose and 370g dextrin of recipe quantity, standby;

[0016] (2) Add the prescribed amount of sucrose and dextrin into purified water at 55°C, stir evenly, prepare a solution with a solid content of 8%, cool down to 36°C, and set aside;

[0017] (3) Mix 1400g of starch and 250g of silicon dioxide in the prescription amount evenly, slowly add to the above (2), stir evenly, and set aside;

[0018] (4) Cool the material in the above (3) to 5°C, crystallize under stirring at 80 rpm for 2 hours, collect the filter cake by suction filtration, wash the filter cake with 0°C purified water 10 times the total amount of feed, and dry at 40°C , to obtain the compressible sucrose of the present invention.

Embodiment 2

[0020] Components:

[0021] Material name

Proportion(%)

Weight (g)

sucrose

94.2

9420

Dextrin

2.5

250

starch

1.5

150

silica

1.8

180

[0022] Preparation:

[0023] (1) take by weighing 9420g sucrose and 250g dextrin of recipe quantity, standby;

[0024] (2) Add the prescribed amount of sucrose and dextrin into purified water at 68°C, stir evenly, prepare a solution with a solid content of 16%, cool down to 42°C, and set aside;

[0025] (3) Mix 150g of starch and 180g of silicon dioxide in the prescription amount evenly, slowly add to the above (2), stir evenly, and set aside;

[0026] (4) Cool the material in the above (3) to 9°C, crystallize under stirring at 110 rpm for 4 hours, collect the filter cake by suction filtration, wash the filter cake with 5°C purified water 10 times the total amount of feed, and dry at 58°C , to obtain the compressible sucrose of the present invention.

Embodiment 3

[0028] Components:

[0029] Material name

Proportion(%)

Weight (g)

sucrose

80

8000

Dextrin

14.5

1450

starch

4

400

silica

1.5

150

[0030] Preparation:

[0031] (1) take by weighing 8000g sucrose and 1450g dextrin of recipe quantity, standby;

[0032] (2) Add the prescribed amount of sucrose and dextrin into purified water at 60°C, stir evenly, prepare a solution with a solid content of 12%, cool to 40°C, and set aside;

[0033] (3) Mix 400g of starch and 150g of silicon dioxide in the prescription amount evenly, slowly add to the above (2), stir evenly, and set aside;

[0034] (4) Cool the material in the above (3) to 7°C, crystallize under stirring at 90 rpm for 3 hours, collect the filter cake by suction filtration, wash the filter cake with purified water at 3°C ​​10 times the total amount of input, and dry at 50°C , to obtain the compressible sucrose of the present invention.

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Abstract

Disclosed are innovative drug excipient compressible sucrose and a preparation method thereof. The innovative drug excipient compressible sucrose is prepared by taking 79.8-94.2% of sucrose, 2.5-14.5% of dextrin, 1.5-14.0% of starch and 1.5-2.5% of silica. The compressible sucrose prepared is high in fluidity, compressibility, drug dissolving quantity and dissolution speed; the compressible sucrose is produced at low temperature, so that color, smell and taste that sucrose should have are retained, chewing sense is improved, and the compressible sucrose is especially suitable for buccal tablets and chewable tablets.

Description

technical field [0001] The invention relates to an innovative pharmaceutical auxiliary material compressible sucrose, namely compressible sucrose and a preparation method thereof. Background technique [0002] Sucrose is a very traditional pharmaceutical excipient, and compressible sucrose is an innovative pharmaceutical excipient that uses sucrose for deep processing. It is a physical and chemical modification of sucrose so that it no longer has a crystalline form and becomes an amorphous powder. When making tablets (buccal tablets, chewable tablets) as excipients, poor fluidity and high hardness can easily cause some weaknesses such as tablet splits and uneven tablet weight, while completely retaining the inherent sweetness and color of sucrose Fragrance, in line with the requirements of modern pharmaceutical excipients and the development needs of preparations. Therefore, it is more convenient to use as an excipient for tablets than sucrose. It can be directly used for t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K47/36
Inventor 郭彧张晓薇谢雁鸣张凯欧石军艾风刘华亮
Owner GUANGDONG GUOYUAN GUOYAO PHARMA CO LTD
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