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Pharmaceutic adjuvant microcrystalline cellulose pellet core and preparation method thereof

A technology of microcrystalline cellulose and pharmaceutical excipients, which is applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, and block transportation, etc., can solve problems such as impact, and achieve the effect of simple preparation process

Active Publication Date: 2015-04-29
GUANGDONG GUOYUAN GUOYAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, medicinal blank cores have been produced in China, but there is still a certain gap from foreign products, especially the surface finish, roundness and friability of blank cores. At the same time, many companies want to improve the friability and Surface smoothness, hypromellose, polyvinylpyrrolidone, ethyl cellulose and other semi-synthetic macromolecular substances are mostly used as adhesives. Since these substances are mostly chemically synthesized, too many related impurities in them will have a certain impact on the properties of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Components:

[0019] Material name

Proportion(%)

Weight (g)

Microcrystalline Cellulose Avicel PH-105

54

540

Microcrystalline Cellulose Avicel RC-581

13

130

powdered cellulose

33

33

[0020] Preparation:

[0021] (1) Weigh 540g of microcrystalline cellulose Avicel PH-105, 130g of microcrystalline cellulose Avicel RC-581, 33g of powdery cellulose, and set aside;

[0022] (2) Add 130g of microcrystalline cellulose Avicel RC-581 and 33g of powdered cellulose into 50% ethanol, stir evenly, and prepare a solution with a solid content of 0.1%, and set aside;

[0023] (3) Add the solution in (2) to the ultra-high pressure nano homogeneous disperser, set the pressure to 1800kg / cm 3 , homogeneously disperse once, and use it as a binder for later use;

[0024] (4) Put 50g of microcrystalline cellulose Avicel PH-105 in the centrifugal granulator, adjust the air inlet of the centrifugal granulator to 15HZ, the...

Embodiment 2

[0028] Components:

[0029] Material name

Proportion(%)

Weight (g)

Microcrystalline Cellulose Avicel PH-105

73

730

Microcrystalline Cellulose Avicel RC-581

3

30

powdered cellulose

24

240

[0030] Preparation:

[0031] (1) Weigh 730g of microcrystalline cellulose Avicel PH-105, 30g of microcrystalline cellulose Avicel RC-581, 240g of powdered cellulose, and set aside;

[0032] (2) Add 30g of microcrystalline cellulose Avicel RC-581 and 240g of powdery cellulose into 50% ethanol, stir evenly, and prepare a solution with a solid content of 4.5%, and set aside;

[0033] (3) Add the solution in (2) to the ultra-high pressure nano homogeneous disperser, set the pressure to 1100kg / cm 3 , dispersed homogeneously for 3 times, and used as an adhesive for standby;

[0034] (4) Put 120g of microcrystalline cellulose Avicel PH-105 in the centrifugal granulator, adjust the air inlet of the centrifugal granulator to 16...

Embodiment 3

[0038] Components:

[0039] Material name

Proportion(%)

Weight (g)

Microcrystalline Cellulose Avicel PH-105

88

880

Microcrystalline Cellulose Avicel RC-581

4

40

powdered cellulose

8

80

[0040] Preparation:

[0041] (1) Take microcrystalline cellulose Avicel PH-105 880g, microcrystalline cellulose Avicel RC-581 40g, powdery cellulose 80, set aside;

[0042] (2) Add 40g of microcrystalline cellulose Avicel RC-581 and 80g of powdered cellulose into 50% ethanol, stir evenly, and prepare a solution with a solid content of 7% for subsequent use;

[0043] (3) Add the solution in (2) to the ultra-high pressure nano homogeneous disperser, set the pressure to 300kg / cm 3 , homogeneously dispersed 5 times, and used as a binder for standby;

[0044](4) Put 180g of microcrystalline cellulose Avicel PH-105 in the centrifugal granulator, adjust the air inlet of the centrifugal granulator to 17HZ, the inlet air temperat...

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PUM

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Abstract

The invention discloses a pharmaceutic adjuvant microcrystalline cellulose pellet core and a preparation method thereof. The pellet core comprises the following materials: 50-90% of microcrystalline cellulose Avicel PH-105, 2-20% of microcrystalline cellulose Avicel RC-581, and 7-35% of flour cellulose; the preparation method comprises the following steps: adopting the microcrystalline cellulose Avicel PH-105 as a raw material; configuring an adhesive in high pressure and homogeneity by adopting the microcrystalline cellulose Avicel RC-581 and the flour cellulose; efficiently ensuring the rigidity and friability of micropills by controlling the viscosity of the adhesive. According to the invention, a centrifugal granulator is adopted for pelletizing; the method is short in pelletizing time; the prepared micropills are high in rounding degree, and low in friability, and avoid excessive penetration and surface roughness of the micropills.

Description

technical field [0001] The invention relates to a pharmaceutical auxiliary material specially used for sustained and controlled release pellet preparations, that is, a pharmaceutical auxiliary material microcrystalline cellulose pellet core and a preparation method thereof. Background technique [0002] Sustained and controlled-release pellets are a multi-unit dosage form. Due to their small particle size, they are evenly distributed in the gastrointestinal tract, which can reduce local irritation and improve the consistency of drug release, thereby reducing adverse reactions caused by drug burst release. ; The dosage form has high processing flexibility and is suitable for subsequent compression into pellets or capsules. With the advancement of equipment, pharmaceutical excipients and preparation technology, sustained and controlled release pellets have achieved great development in preparation and clinical application due to their unique advantages. [0003] The common pr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/38A61K9/16
Inventor 郭彧张晓薇谢雁鸣张凯艾风欧石军刘华亮伍彪
Owner GUANGDONG GUOYUAN GUOYAO PHARMA CO LTD