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Acrivastine capsule and preparation method thereof

A technology of Avastin and capsules, applied in the field of pharmaceutical preparations, to achieve the effects of simplifying operation steps, reducing the generation of agglomerates, and improving product yield

Active Publication Date: 2018-06-08
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In view of this, the object of the present invention is to provide a kind of Avastin capsule and preparation method thereof, the preparation method of the present invention solves the content uniformity problem and the dissolution rate problem of Avastin capsule, simultaneously simplifies the operation of production process steps to increase product yield

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] (1) Prescription

[0037] Raw materials

Prescription amount (g)

Prescription ratio (%)

Avastin

10

3.3

lactose

246.5

82.2

sodium starch glycolate

24

8

Povidone K30

18

6

Magnesium stearate

1.5

0.5

total

300

100

[0038] (2) Preparation process

[0039]a. Pretreatment: after pulverizing the Avastin of prescription quantity, the lactose of 20% prescription quantity, the carboxymethyl starch sodium of 50% prescription quantity together, pass through 80 mesh sieves together with the lactose of remaining 80% prescription quantity;

[0040] b. Slurry preparation: add the povidone of the prescribed amount into water to prepare a 10% solution;

[0041] c. Granulation: Mix the sieved powder evenly, add 10% povidone K30 solution to make a soft material, granulate with a 14-mesh sieve, dry at 60±5°C, granulate with a 40-mesh sieve to obtain dry granules;

[0042] d. Blending: the dr...

Embodiment 2

[0048] (1) Prescription

[0049] Raw materials

Prescription amount (g)

Prescription ratio (%)

Avastin

10

3.3

lactose

258.5

86.2

sodium starch glycolate

24

8

Povidone K30

6

2

Magnesium stearate

1.5

0.5

total

300

100

[0050] (2) Preparation process

[0051] a. Pretreatment: after pulverizing the Avastin of prescription quantity, the lactose of 20% prescription quantity, the carboxymethyl starch sodium of 50% prescription quantity together, pass through 80 mesh sieves together with the lactose of remaining 80% prescription quantity;

[0052] b. Slurry preparation: add the povidone of the prescribed amount into water to prepare a 10% solution;

[0053] c. Granulation: Mix the sieved powder evenly, add 10% povidone K30 solution to make a soft material, granulate with a 14-mesh sieve, dry at 60±5°C, granulate with a 40-mesh sieve to obtain dry granules;

[0054] d. Blending: the dr...

Embodiment 3

[0060] (1) Prescription

[0061] Raw materials

Prescription amount (g)

Prescription ratio (%)

Avastin

10

3.3

lactose

264.5

88.2

sodium starch glycolate

24

8

Magnesium stearate

1.5

0.5

total

300

100

[0062] (2) Preparation process

[0063] a. Pretreatment: After pulverizing the Avastin of the prescribed amount, the lactose of 20% of the prescribed amount, and the sodium starch glycolate of 50% of the prescribed amount, pass through an 80-mesh sieve with the lactose of the remaining 80% of the prescribed amount;

[0064] b. Granulation: Mix the sieved powder evenly, add water-based soft material, granulate with a 14-mesh sieve, dry at 60±5°C, and granulate with a 40-mesh sieve to obtain dry granules;

[0065] c. Blending: the dry granules obtained in step b are uniformly mixed with the magnesium stearate of the prescribed amount and the disintegrant of 50% of the prescribed amount, and fille...

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Abstract

The invention belongs to the field of pharmaceutical preparations and in particular relates to an acrivastine capsule and a preparation method thereof. The acrivastine capsule disclosed by the invention is composed of the following components in percentage by mass: 3.3% of acrivastine, 80%-90% of a filling agent, 8%-12% of a disintegrating agent and 0.5%-2% of a lubricating agent. The acrivastinecapsule disclosed by the invention solves the problems that high probability of forming block mass while adding an adhesive solution for preparing a soft material, difficult pelletization and low yield. An adhesive is removed in the formula, a certain amount of carboxymethyl starch sodium or cross-linked sodium carboxymethylcellulose is added to serve as the disintegrating agent and has certain adhesive performance, and the soft material prepared is loose and does not produce any block mass. The invention further provides a preparation method of the preparation. The preparation method can ensure uniform particles, and is high in yield, simple in operation, low in cost and suitable for industrialized production, the product is stable and controllable in quality, and the drug dissolution rate reaches 85% or higher within 15 minutes.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an Avastin capsule and a preparation method thereof. Background technique [0002] Allergic rhinitis is an allergic disease that occurs in the nasal mucosa, characterized by nasal itching, sneezing, hypersecretion, and swelling of the nasal mucosa. According to a comprehensive report published by the International Federation of Otorhinolaryngology in 1997, the prevalence of allergic rhinitis in the population ranges from 10% to 40%. The disease is divided into perennial allergic rhinitis and seasonal allergic rhinitis, the latter also known as "hay fever". The incidence of allergic rhinitis is closely related to heredity and environment, and the incidence of the disease has been on the rise in recent years. The treatment of this disease is mainly divided into specific treatment and non-specific treatment. The former mainly refers to immunotherapy, and the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4439A61K47/36A61K47/38A61K47/26A61P37/08A61P11/02A61P17/00A61P17/04
CPCA61K9/4858A61K9/4866A61K31/4439
Inventor 罗敏兰洁传娜
Owner CHONGQING HUAPONT PHARMA
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