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Medicinal preparations containing racecadotril and preparation methods

A technology of racecadotril and filler, which is applied in the field of medicine, can solve the problems of unsatisfactory treatment effect of children's diarrhea and children's difficulty in swallowing, and achieve the effect of good treatment effect and easy administration

Inactive Publication Date: 2015-12-09
黑龙江童医生儿童生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to provide a pharmaceutical preparation containing racecadotril and its preparation method, which solves the problem that the existing racecadotril preparation is difficult for children to swallow and the treatment effect on children's diarrhea is not ideal.

Method used

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  • Medicinal preparations containing racecadotril and preparation methods
  • Medicinal preparations containing racecadotril and preparation methods
  • Medicinal preparations containing racecadotril and preparation methods

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0063] The preparation method of racecadotril oral pellet gel for children of the present invention specifically comprises the following steps:

[0064] 1) Preparation of drug-containing pellets

[0065] ① Evenly mix the weighed racecadotril, filler, and binder to make a soft material, then extrude and spheronize to make drug-containing pills, or make drug-containing pills in a fluidized bed for later use;

[0066] ②The drug-containing pills and micro-pills are coated with the coating materials in a fluidized bed to make drug-containing micro-pills;

[0067] 2) Preparation of oral pellet gel

[0068] ① Add curing agent, sweetener, fragrance and preservative to water and stir to dissolve, add gel forming agent to swell for 10-30 minutes, heat in a water bath at 75-90°C for 15-25 minutes, stir to dissolve, add appropriate amount to adjust pH agent, adjust the pH to 5-8, make up to the full amount with distilled water, and sieve while it is hot;

[0069] ②Under isothermal cond...

Embodiment 1

[0101] A racecadotril oral pellet gel, measured in 1000ml, consists of the following components:

[0102]

[0103] Add water to make up the balance.

[0104] The preparation method is to uniformly mix racecadotril raw materials with crystalline cellulose and starch slurry to make a soft material, then extrude and spheronize to make drug-containing pills, or to make drug-containing pills in a fluidized bed; The vegetarian pills are fluidized bed coated to make Chinese medicine extract pellets;

[0105] Sieve calcium chloride, sucrose, orange essence, and sorbic acid separately (50 mesh), add water and stir to dissolve, add carrageenan, konjac powder swells for 10-30 minutes, heat in a water bath at 75-90°C for 15-25 minutes, and stir Make it dissolve, add an appropriate amount of citric acid, adjust the pH to 5-8, make up to the full amount with distilled water, and sieve while it is hot. At the same temperature, add the drug-containing pellets, stir well, and distribute w...

Embodiment 2

[0107] A racecadotril oral pellet gel, measured in 1000ml, consists of the following components:

[0108]

[0109] Add water to make up the balance.

[0110] The preparation method is to uniformly mix the racecadotril raw material with lactose and starch slurry to make a soft material, then extrude and spheronize to make drug-containing pills, or to make drug-containing pills in a fluidized bed; The pellets are coated with a fluidized bed to make drug-containing pellets;

[0111] Sieve calcium chloride, xylitol, strawberry essence, and propyl paraben separately (50 mesh), add water and stir to dissolve, add carrageenan, agar, and konjac gum to swell for 10-30 minutes, and place in a 75-90°C water bath Heat for 15-25 minutes, stir to dissolve, add sodium dihydrogen phosphate and appropriate amount of disodium hydrogen phosphate, adjust pH to 5-8, make up to full amount with distilled water, and sieve while hot. At the same temperature, add the drug-containing pellets, stir...

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Abstract

The invention discloses medicinal preparations containing racecadotril and preparation methods, wherein racecadotril oral pellet gel is prepared from the following main ingredients in parts by mass: 0.01-10 parts of racecadotril, 10-100 parts of filling agent, 5-60 parts of binding agent, 2-20 parts of pellet coating material, 2-50 parts of gel forming agent, 0.5-2 parts of curing agent, 0.2-200 parts of sweetening agent, 0.5-5 parts of flavoring agent, 0.1-1.5 parts of preservative and 0-30 parts of pH conditioning agent; racecadotril oral pellet emulsion is prepared from the following main ingredients in parts by mass: 0.01-10 parts of racecadotril, 10-100 parts of filling agent, 5-60 parts of binding agent, 2-20 parts of pellet coating material, 50-350 parts of oil phase, 1-300 parts of emulgator and 0-150 parts of co-emulsifier. The medicinal preparations disclosed by the invention have the beneficial effects that the racecadotril oral pellet products are easy to take by children, and have a good treatment effect for diarrhea of children.

Description

technical field [0001] The invention belongs to the technical field of medicines, and relates to a medicine preparation containing racecadotril and a preparation method thereof. Background technique [0002] Diarrhea has always been a concern, and its most common cause is intestinal infection. As many as 3 to 4 million people die from intestinal infection every year in the world, especially infants, preschool children and the elderly. The morbidity and mortality rate higher. Racecadotril (racecadotril) is an antidiarrheal drug with a new mechanism of action, and has a high specific antisecretory effect. Developed by the French company Bioproject, it was first launched in France under the trade name Tiorfan in 1993 for the treatment of acute diarrhea in adults. In 2001, the indication for diarrhea in children was added. [0003] Racecadotril is a lipophilic dipeptide derivative of thiophene (thiorphan), which is an enkephalinase inhibitor, which protects endogenous enkepha...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/265A61K9/107A61K9/16A61P1/12
Inventor 彭项雨姜波刘晓磊王娜
Owner 黑龙江童医生儿童生物制药有限公司
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