Solid dispersion combination of EGCG (epigallocatechin gallate) with thermal stability and preparation method of solid dispersion combination and application in preparation of solid dispersion combination

A technology of solid dispersion and composition, applied in the direction of organic active ingredients, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of affecting product quality EGCG preparation/product development, product preparation, storage , adverse effects of circulation, poor stability of EGCG, etc.

Active Publication Date: 2015-06-24
南京润瞳畅达医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the disadvantage is that EGCG has poor stability and is easily affected by factors such as temperature, water, pH, etc., especially when it is stored in a liquid environment for 7 days, its hydrolysis / degradation rate reaches more than 17%, even in a solid state, Although the stability will be relatively improved, it is more sensitive to temperature and will gradually degrade in a hot environment, which will seriously affect product quality and the development of EGCG preparations / products, and have serious adverse effects on product preparation, storage, circulation, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Embodiment 1, the solid dispersion of EGCG and sugar alcohols and its preparation

[0089] The prescription quantity is calculated by weight percentage and contains:

[0090] EGCG 1%~10%, preferably 3%,

[0091] Fructose or xylitol 90% to 99%, preferably 97% fructose;

[0092] The preparation method comprises: passing fructose or xylitol through 80-mesh sieve, preferably 100-mesh sieve, weighing according to the prescription amount, dissolving EGCG in ethanol-water solution, preferably in 75% ethanol solution, spraying the solution on Made soft material from fructose or xylitol, wet granulated, dried at 45-70°C, granulated, packaged or bagged, sealed, ready to be obtained;

[0093] Alternatively, the preparation method includes: weighing EGCG, fructose or xylitol, crushing them through a 80-mesh sieve, preferably passing through a 100-mesh sieve, mixing them uniformly in equal increments, or dry granulation, drying at 45-70°C, and sizing , packed or bagged, sealed, t...

Embodiment 2

[0099] Embodiment 2, the solid dispersion of EGCG and sugar alcohols and its preparation

[0100] The prescription quantity is calculated by weight percentage and contains:

[0101] EGCG 1%~10%, preferably 2.5%,

[0102] FOS 90%~99%, preferably 97.5%;

[0103] Its preparation method comprises: passing 80 mesh sieves of fructooligosaccharides, preferably 100 meshes, weighing according to the prescription amount, and dissolving EGCG in ethanol-water solution, preferably 75% ethanol solution, spraying the solution on fructooligosaccharides Made into soft material, wet granulated, dried at 45-70°C, granulated, packaged or bagged, sealed, ready to be obtained;

[0104] Alternatively, the preparation method includes: weighing EGCG and fructooligosaccharides, crushing them through 80 mesh sieves, preferably 100 mesh sieves, mixing uniformly in equal increments, or dry granulation, drying at 45-70°C, granulating, and packaging Or bagged, sealed, that is.

[0105] Further, if n...

Embodiment 3

[0110] Embodiment 3, the solid dispersion of EGCG and sugar alcohols and its preparation

[0111] The prescription quantity is calculated by weight percentage and contains:

[0112] EGCG 1%~5%, preferably 2% salt,

[0113] Mannose oligosaccharides or xylooligosaccharides 5% to 25%, preferably mannose oligosaccharides 10%,

[0114] Sorbitol 70%~94%, preferably 88%;

[0115] Its preparation method comprises: oligosaccharide or xylooligosaccharide, sorbitol respectively pass through 80 mesh sieves, preferably pass through 100 mesh, mix evenly, in addition dissolve EGCG in ethanol-water solution, preferably 75% ethanol solution, the The solution is sprayed into the mixture of mannose-oligosaccharide or xylo-oligosaccharide and sorbitol to make a soft material, wet granulated, dried at 45-70°C, granulated, packed or bagged, sealed, and ready to be obtained;

[0116] Alternatively, the preparation method comprises: weighing EGCG, mannose-oligosaccharides or xylo-oligosaccharides,...

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PUM

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Abstract

The invention provides a solid alcohol solid dispersion combination of EGCG (epigallocatechin gallate) with thermal stability and sugar alcohols. The sugar alcohols include one or more ingredients comprising fructose, newtol, fructo-oligose, xylooligosaccharide, polydextrose, mannitol, cane sugar, glucose, resistant dextrin, sorbitol, maltose, isomalt, mannose oligomer, carbo wax, dextrin, cyclodextrin, hydroxyl-lpropyl-beta-cyclodextrin, microcrystalline cellulose, carboxymethylcellulose, pregelatinized starch, starch, starch sugar, lactose, sodium carboxymethyl starch, proteoglycan, sucralose, aspartame, acesulfame, stachyose, neotame and stevioside, and the sugar alcohols and the EGCG are in (12-80):1 in proportion by weigth. The invention further provides a preparation method of the solid dispersion combination and application in preparation of the solid dispersion combination. By the aid of the solid dispersion combination, the EGCG is effectively improved in stability.

Description

Technical field [0001] The present invention involves a healthy product composition, and its preparation methods and applications. It is specifically the composition of the solid dispersed body of EGCG, as well as its preparation methods and applications.The health compositions described in the present invention include, but not limited to drugs, nutritional health products, medical food, special diet, health food or functional food, ordinary food, etc. Background technique [0002] EGCG, that is, there is no menia cordonin, no meal acid, the structure is as follows, the structure is as follows, [0003] ,, [0004] EGCG is a natural compound that is extracted and separated from green tea. It is the most efficient active monomer of tea polyphenols. It has good safety and extensive physiological activity. Studies have shown that EGCG has antitumor and antiviral virus., Antibacterial, regulating immunity, anti -free radical damage, antioxidant, antioxidant stress, antiphastinal f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A23L1/29A61K31/353A61K47/26A61K47/34A61K47/36A61K47/38A61K47/18A23L33/00
CPCA23V2002/00A61K9/1623A61K9/1641A61K9/1652A61K9/2018A61K9/2031A61K9/2059A61K31/353A61K47/549A23V2200/30A23V2250/606A23V2250/6422A23V2250/61A23V2250/5042A23V2250/28A23V2250/51082A23V2250/51084A23V2250/5118A23V2250/264A23V2250/612A23V2250/242A23V2250/2482
Inventor 张耿元王保红唐湘成
Owner 南京润瞳畅达医药科技有限公司
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