Unfavorable taste-masking drug granule, chewable formulation and preparation process thereof

A technology of taste-masking granules and preparation process, which can be used in pill delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc. It can solve the problems of difficult matrix materials and obvious bitterness, and avoid equipment or processes, and avoid inclusion efficiency not high effect

Inactive Publication Date: 2007-07-11
牛祝琴 +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, for water-soluble and acidic bad-tasting drugs, this method has the following problems: first, the drug is easily soluble in water and the matrix material is difficult to dissolve in water, so the drug cannot be fully combined with the matrix, and some drugs are sprayed. After drying or rotary evaporation, they still gather on the surface of the granules. Therefore, although the mouthfeel is improved compared with that before spray drying and granulation, there is still a strong bitterness; second, the difference between acidic drugs and alkaline stomach-soluble materials Effect, the time of the particles in the mouth is a little longer, after the acidic drug is dissolved in the stomach-soluble matrix material cup, the drug is released in the mouth, and the bitter taste is obvious
Therefore, the method has obvious flaws

Method used

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  • Unfavorable taste-masking drug granule, chewable formulation and preparation process thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0040] Acrylic resin No. 4 375g (Degussa company, Eudragit E-100) is dissolved in dehydrated alcohol 1300g, is mixed with the ethanol solution of acrylic resin, berberine 25g (Hainan Pharmaceutical Factory Co., Ltd.) is dispersed in the water of 320g, obtains For the suspension of berberine, the two solutions are mixed uniformly and heated to 50 degrees Celsius to obtain a solution. The solution is sprayed into a spray dryer for spray drying, the rotating speed is adjusted to 300HZ, and the drying temperature is set to 115-120 degrees Celsius. After collection and drying, 60-120 mesh particles are obtained and sieved. Prepare 800 g of aqueous solution of xanthan gum (Shandong Jinsu Biological Products Co., Ltd.) with a concentration of 1%, add 5 g of sucralose to dissolve to obtain a glue, and pour 400 g of the spray-dried particles into the glue to stir and disperse evenly at 55 degrees Celsius Dried, tested for moisture, sieved to obtain xanthan gum-wrapped granules, added s...

Embodiment 2

[0053] Acrylic resin No. 4 15g (Degussa company, Eudragit E-100) is dissolved in absolute ethanol 100g, is mixed with the ethanol solution of acrylic resin, 15g of dextromethorphan hydrobromide (Shanghai Xinya Pharmaceutical Co., Ltd.) is dispersed In 20g of water, the solution of dextromethorphan hydrobromide was obtained, and the two solutions were mixed uniformly to obtain the solution. The solution is sprayed into a spray dryer for spray drying, the rotating speed is adjusted to 300HZ, and the drying temperature is set to 115-120 degrees Celsius. After collection and drying, 60-120 mesh particles are obtained and sieved. Prepare 100 g of an aqueous solution of gum arabic (Shandong Runyuan Industrial Co., Ltd.) with a concentration of 10%, add 2 g of sucralose to dissolve to obtain a glue agent, pour 20 g of spray-dried particles into the glue agent, stir and disperse evenly, and dry at 55 degrees Celsius , test moisture, sieve to get Arabic gum-wrapped granules after passi...

Embodiment 3

[0065] Acrylic resin No. 4 750g (Degussa company, Eudragit E-100) is dissolved in absolute ethanol 3000g, is mixed with the ethanol solution of acrylic resin, paracetamol 150g (Shanghai Xinya Pharmaceutical Co., Ltd.) is dispersed in 600g The solution of paracetamol was obtained in the water, and the two solutions were mixed uniformly to obtain the solution. The solution is sprayed into a spray dryer for spray drying, the rotating speed is adjusted to 300HZ, and the drying temperature is set to 115-120 degrees Celsius. After collection and drying, 60-120 mesh particles are obtained and sieved. Prepare 500g of an aqueous solution of gum arabic (Shandong Runyuan Industrial Co., Ltd.) with a concentration of 10%, add 20g of sucralose to dissolve to obtain a glue agent, pour 500g of spray-dried particles into the glue agent, stir and disperse evenly, and dry at 55 degrees Celsius , test moisture, sieve to get Arabic gum-wrapped granules after passing the test, add fillers such as ...

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Abstract

The invention relates to a particles used to shade bad taste of drug, wherein it is formed by corn element with active component and continuous polymer dress; the corn element is formed by active component and acrylic resin at 1:0.5-1:20 mass ratio; the dress is soluble gel slurry; and the drug is soluble in acid solution with bad taste. And the production comprises that: dissolving drug and soluble base material into solvent; using atomizing drier or rotation evaporator to obtain dry particles; then graining them at neutral condition via gel material; forming dress that separates drug and taste bud on the surface of particles; preparing oral agent via general method. The invention can avoid releasing bad taste in mouth but release drug in stomach.

Description

technical field [0001] The invention relates to a taste-masking granule of a drug with bad taste, a chewable preparation and a preparation process thereof, more specifically a chewable preparation of a drug with good water solubility and acidity and a bad taste and a preparation process thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] The basic requirements of pharmaceutical preparations are safe, effective, and quality-controllable. In addition, pharmaceutical preparations can improve the bad smell and taste of drugs, and improve patients' tolerance and compliance, so that the active ingredients can fully play their role . As we all know, most of the medicines have bad smell and taste, therefore, especially children and the elderly have huge adverse effects when administered. In consideration of improving the compliance and taking characteristics of children and the elderly, many drugs have been developed into dosage forms suita...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/32A61K9/16A61K9/20A61K45/00
Inventor 朱祝琴钟少虎向生贵
Owner 牛祝琴
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