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Racecadotril granules and preparation method thereof

A technology of racecadotril and granules, which is applied in the digestive system, pharmaceutical formulas, medical preparations of non-active ingredients, etc., can solve problems such as poor taste, achieve low production costs, increase solubility and dissolution rate, and increase stability sexual effect

Inactive Publication Date: 2020-02-28
JIANMIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the deficiencies of the prior art, the present invention provides a racecadotril granule and a preparation method thereof, which not only solves the problems of the current racecadotril granules with bitter taste and poor mouthfeel, but also improves the preparation Dissolution, making it better accepted by pediatric patients

Method used

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  • Racecadotril granules and preparation method thereof
  • Racecadotril granules and preparation method thereof
  • Racecadotril granules and preparation method thereof

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preparation example Construction

[0034] The embodiment of the present invention also provides a preparation method of racecadotril granules, which specifically includes the following steps:

[0035] S1, pulverizing the racecadotril raw material with a jet mill, passing through a 150-mesh sieve for subsequent use;

[0036] S2. Dissolve the raw material of racecadotril obtained in step S1 of the prescribed amount in an appropriate amount of ethanol, and then dissolve the prescribed amount of polyethylene glycol in the ethanol solution;

[0037] S3, drying and pulverizing the solution obtained in step S2 under reduced pressure to obtain a solid dispersion of racecadotril;

[0038] S4. Take the prescription amount of racecadotril solid dispersion and filler obtained in step S3, mix evenly, stir in a wet granulator and add binder to prepare soft material, pass through a 50-65 mesh sieve to granulate;

[0039] S5, putting the particles in step S4 into a fluidized bed for drying;

[0040] S6. Sizing the granules o...

Embodiment 1

[0059]

[0060] Table 4

[0061] The production process is:

[0062] (1) Racecadotril is pulverized by air flow and the raw material of racecadotril passed through a 150 mesh sieve is dissolved in ethanol, and then the prescription amount of polyethylene glycol 6000 is dissolved in the above solution;

[0063] (2) Drying and pulverizing the solution obtained in (1) under reduced pressure to obtain a racecadotril solid dispersion;

[0064] (3) Mix the above-mentioned solid dispersion and lactose in the prescribed amount evenly, stir and add hydroxypropyl cellulose in a wet granulator to prepare a soft material, and granulate through a 60-mesh sieve;

[0065] (4) Put the granules in (3) into a fluidized bed for drying, control the inlet air temperature of the fluidized bed to be 50°C, the outlet air temperature to be 45°C, and the residence time of the material in the fluidized bed to be about 25 minutes;

[0066] (5) sizing the particles obtained in (4) with a 50-mesh siev...

Embodiment 2

[0069]

[0070] table 5

[0071] The production process is:

[0072] (1) Racecadotril is pulverized by air flow and the raw material of racecadotril passed through a 150 mesh sieve is dissolved in ethanol, and then the prescription amount of polyethylene glycol 6000 is dissolved in the above solution;

[0073] (2) Drying and pulverizing the solution obtained in (1) under reduced pressure to obtain a racecadotril solid dispersion;

[0074] (3) Mix the above-mentioned solid dispersion and lactose in the prescribed amount evenly, stir and add hydroxypropyl cellulose in a wet granulator to prepare a soft material, and granulate through a 60-mesh sieve;

[0075] (4) Put the granules in (3) into a fluidized bed for drying, control the inlet air temperature of the fluidized bed to be 50°C, the outlet air temperature to be 45°C, and the residence time of the material in the fluidized bed to be about 25 minutes;

[0076] (5) sizing the particles obtained in (4) with a 50-mesh siev...

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Abstract

The invention discloses racecadotril granules and a preparation method thereof. The racecadotril granules comprise, by mass, 10-20% of racecadotril solid dispersions, 80-90% of fillers, 0.1-1% of flavoring agent, 0.5-1.5% of binders and 0.05-0.15% of glidant. The racecadotril solid dispersions comprise, by mass, 5-20% of racecadotril and 80-95% of polyethylene glycol. The racecadotril granules andthe technological preparation method thereof have the advantages that the bitter taste of the medicine can be covered up, the taste of the medicine can be improved, the compliance of children duringmedication can be enhanced, and the dissolution rate and stability of products can be further increased.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to racecadotril granules and a preparation method thereof. Background technique [0002] Racecadotril is an enkephalinase inhibitor, which can selectively and reversibly inhibit enkephalinase, thereby protecting endogenous enkephalins from degradation and prolonging the physiological function of endogenous enkephalins in the digestive tract. Active, reduces excessive secretion of water and electrolytes. Oral administration of racecadotril acts on peripheral enkephalinase, does not affect the activity of enkephalinase in the central nervous system, and has no significant effect on gastrointestinal peristalsis and intestinal basal secretion. [0003] Because the crude drug of racecadotril tastes bitter and is almost insoluble in water, its preparations often have poor mouthfeel and low dissolution rate. Therefore, how to develop a new racecadotril gra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/265A61K47/10A61P1/12
CPCA61K9/1641A61K31/265A61P1/12
Inventor 任霞赵刚黄志军余丽花郭平张梦婷黄珮闻吴木琴
Owner JIANMIN PHARMA GRP CO LTD
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