Pharmaceutical preparation containing racecadotril and preparation method thereof

A technology for racecadotril and pharmaceutical preparations, which is applied in the field of pharmaceutical preparations containing racecadotril and its preparation, and can solve the problems of insignificant taste-masking effect, reduced dissolution rate, low solubility of racecadotril, etc. , to achieve the effect of improving water vapor permeability and tension, increasing film forming temperature, and good drug loading performance

Active Publication Date: 2022-05-13
BEIJING CHILDRENS HOSPITAL AFFILIATED TO CAPITAL MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to our experiments, it is difficult to obtain the ideal effect with this prescription and process. The curing time in the preparation process is long, and the requirements for the operation and control of the production process are strict, and the production efficiency is low. At the same time, the performance of the product still needs to be improved.
This is reflected in: Although the insoluble film-like structure formed by using NE30D material can obviously cover the bitter taste of racecadotril, but the Such materials are water-insoluble materials, and the mechanism for controlling their release is mainly through the pores formed by swelling or crystallization of surfactants to regulate drug release. The early stage of drug release is too slow, and the relatively fast drug release characteristics in the early stage of administration cannot be achieved to meet other requirements. In vivo absorption and rapid drug release requirements; at the same time, the copolymer in NE30D aqueous dispersion is usually in the form of small spherical particles , during the preparation process, small polymer particles aggregate, soften, and fuse with each other to form a film or skeleton. Therefore, this type of material usually needs to be cured to fully fuse the polymer film. Since this curing time is usually long, it makes The prepared preparations usually have the problems of reduced dissolution rate and poor stability durin

Method used

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  • Pharmaceutical preparation containing racecadotril and preparation method thereof
  • Pharmaceutical preparation containing racecadotril and preparation method thereof
  • Pharmaceutical preparation containing racecadotril and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] prescription:

[0041]

[0042]

[0043] Preparation Process:

[0044] (1) Pulverize the racecadotril raw material with an airflow mill to obtain racecadotril micropowder, with an average particle diameter of D 50 Control within the range of 20 μm; use a universal pulverizer to pulverize ethyl cellulose to obtain ethyl cellulose fine powder with an average particle size of 45 μm;

[0045] (2) Weighing the prescription amount NE30D, diluted with 1.5 times the amount of purified water; under the action of high shear, add ethyl cellulose fine powder to prepare a binder solution;

[0046] (3) Put racecadotril micropowder and sucrose (120 mesh) in a high-shear wet granulator, add a binder solution for wet granulation, and place the prepared wet granules in a blast drying box, Dry at 60°C for 4 hours, and obtain drug-containing granules after granulation;

[0047] (4) Mix the drug-containing granules with sucrose (40 mesh), peach essence and silicon dioxide in a th...

Embodiment 2

[0049] prescription:

[0050]

[0051] Preparation Process:

[0052] (1) Pulverize the racecadotril raw material with an airflow mill to obtain racecadotril micropowder, with an average particle diameter of D 50 Control within the range of 20 μm; use a universal pulverizer to pulverize ethyl cellulose to obtain ethyl cellulose fine powder with an average particle size of 45 μm;

[0053] (2) Weighing the prescription amount NE30D, diluted with 1.5 times the amount of purified water; under the action of high shear, add ethyl cellulose fine powder to prepare a binder solution;

[0054] (3) Put racecadotril micropowder and sucrose (120 mesh) in a high-shear wet granulator, add a binder solution for wet granulation, and place the prepared wet granules in a blast drying box, Dry at 60°C for 4 hours, and obtain drug-containing granules after granulation;

[0055] (4) Mix the drug-containing granules with sucrose (40 mesh), peach essence and silicon dioxide in a three-dimensio...

Embodiment 3

[0057] prescription:

[0058]

[0059] Preparation Process:

[0060] (1) Pulverize the racecadotril raw material with an airflow mill to obtain racecadotril micropowder, with an average particle diameter of D 50 Control within the range of 20 μm; use a universal pulverizer to pulverize ethyl cellulose to obtain ethyl cellulose fine powder with an average particle size of 20 μm;

[0061] (2) Weighing the prescription amount NE30D, diluted with 1.5 times the amount of purified water; under the action of high shear, add ethyl cellulose fine powder to prepare a binder solution;

[0062] (3) Put racecadotril micropowder and sucrose (120 mesh) in a high-shear wet granulator, add a binder solution for wet granulation, and place the prepared wet granules in a blast drying box, Dry at 60°C for 4 hours, and obtain drug-containing granules after granulation;

[0063] (4) Mix the drug-containing granules with sucrose (40 mesh), peach essence and silicon dioxide in a three-dimensio...

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Abstract

The invention discloses a pharmaceutical preparation containing racecadotril and a preparation method thereof, and belongs to the field of pharmaceutical preparations. The preparation comprises racecadotril, a taste masking material, a filling agent, a flavoring agent and a lubricant, the taste masking material is composed of NE30D and ethyl cellulose fine powder according to a certain proportion, and further aggregation of an acrylate copolymer is prevented through formation of an incompatible phase between ethyl cellulose and acrylate copolymer particles; the water vapor permeability and tension of the membrane are improved, so that the drug release rate is stabilized, the bitter taste of the drug is effectively covered, and the membrane is suitable for acute diarrhea treatment of infant and child patients; the product stability is good; the preparation method has the advantages of good drug entrapment performance, good taste masking effect, and simple preparation process by adopting a conventional wet granulation process, and is more suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical preparation containing racecadotril and a preparation method thereof. Background technique [0002] The information disclosed in this background section is only intended to increase the understanding of the general background of the present invention, and is not necessarily taken as an acknowledgment or any form of suggestion that the information constitutes the prior art already known to those skilled in the art. [0003] Racecadotril (Racecadotril) is a kind of enkephalinase inhibitor, is the antidiarrheal drug of a kind of new mechanism of action developed by French Bioproject company, and it can inhibit enkephalinase selectively and reversibly, thereby Protect endogenous enkephalins from degradation, prolong the physiological activity of endogenous enkephalins in the digestive tract, directly inhibit the excessive secretion of ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/265A61K47/38A61K47/32A61P1/12
CPCA61K9/1652A61K9/1635A61K31/265A61P1/12
Inventor 王景雁王晓玲梅冬张艳菊
Owner BEIJING CHILDRENS HOSPITAL AFFILIATED TO CAPITAL MEDICAL UNIV
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