Epigallocatechin gallate sustained-release capsule and preparation method thereof

A technology of epigallocatechin and gallate, which is applied in the field of epigallocatechin gallate sustained-release capsules and its preparation, can solve the unsolved problems of hygroscopicity and fluidity, and affect the dissolution rate and Curative effect, compliance, poor compliance and other issues, to achieve the effect of prolonging the effective time of action, reducing the fluctuation of blood drug concentration, and stabilizing the quality

Pending Publication Date: 2021-09-24
AFFILIATED CANCER HOSPITAL OF SHANDONG FIRST MEDICAL UNIV SHANDONG CANCER INST (SHANDONG CANCER HOSPITAL) +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Chinese patent CN101167719A discloses a kind of epigallocatechin gallate (EGCG) microcapsule particle and preparation technology thereof, and this microcapsule particle is capsule core with epigallocatechin gallate, with ethyl cellulose (ECG) ) and / or polyethylene glycol (PEG) as the capsule material, and carboxymethyl starch sodium (CMS-Na) is used as the accelerator, but the microcapsule particles have a short half-life in the organism and are slowly eliminated. It needs to take medicine many times to achieve the curative effect, the medicine is more frequent, and the patient's compliance with the medicine is poor.
The camellia extract sustained-release preparation is composed of the following raw materials by weight percentage: 4-65% of camellia extract, 25-50% of skeleton material, 15-50% of diluent, 1-4% of filler, and 1% of lubricant %, the sustained-release preparation does not solve the hygroscopicity and fluidity problems of epigallocatechin gallate, which affects the dissolution rate and curative effect of the sustained-release preparation
[0008] Considering the problems of hygroscopicity and fluidity of epigallocatechin gallate, as well as its short half-life in vivo and slow elimination, its common dosage form needs to be taken several times a day to achieve the curative effect, and the medicine is more frequent. Compliant, compliance is poor, so it is of great significance to develop a new type of epigallocatechin gallate slow control agent

Method used

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  • Epigallocatechin gallate sustained-release capsule and preparation method thereof
  • Epigallocatechin gallate sustained-release capsule and preparation method thereof
  • Epigallocatechin gallate sustained-release capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037]

[0038] 2. Preparation method

[0039] Pulverize epigallocatechin gallate with a pulverizer and pass through a 100-mesh sieve; weigh 12g of epigallocatechin gallate, 1g of ascorbyl palmitate, 15g of hydroxypropyl methylcellulose, and 50g of microcrystalline fiber Add Su PH101 to the wet granulator and mix evenly, then add an appropriate amount of aqueous solution to make a suitable soft material, stirring speed 400rpm, chopping speed 400rpm; extrude the soft material and spheronize to obtain wet skeleton pellets, extrusion speed 30rpm, spheronize The speed is 1000pm, the spheronization time is 5 minutes, and the wet pellet core is obtained; the wet pellet is dried in a fluidized bed for 10 minutes, and sieved to obtain a 20-40 mesh pellet core; weigh 15g Eudragit RS100, 3g triethyl citrate , 3g povidone k30, 6g magnesium stearate are dispersed in 90% ethanol, stir evenly, and preparation concentration is 5% coating liquid; Gained contains pill core coating, 60 ℃ of ...

Embodiment 2

[0041]

[0042] 1. Preparation method

[0043] Use a pulverizer to crush epigallocatechin gallate and pass through a 100-mesh sieve; weigh 10g of epigallocatechin gallate, 1g of ascorbyl palmitate, 20g of hydroxypropyl methylcellulose, and 80g of microcrystalline fiber Add Su PH101 to the wet granulator and mix evenly, then add an appropriate amount of aqueous solution to make a suitable soft material, stirring speed 400rpm, chopping speed 400rpm; extrude the soft material and spheronize to obtain wet skeleton pellets, extrusion speed 30rpm, spheronize The speed is 1000pm, the spheronization time is 5 minutes, and the wet pellet core is obtained; the wet pellet is dried in a fluidized bed for 10 minutes, and sieved to obtain a 20-40 mesh pellet core; weigh 20g Eudragit RS100, 4g triethyl citrate , 4g povidone k30, 4g magnesium stearate are dispersed in 90% ethanol, stir evenly, and preparation concentration is 5% coating solution; Gained contains pill core coating, 60 ℃ of ...

Embodiment 3

[0045]

[0046]

[0047] 1. Preparation method

[0048] Use a pulverizer to crush epigallocatechin gallate and pass through a 100-mesh sieve; weigh 20g of epigallocatechin gallate, 2g of ascorbyl palmitate, 20g of hydroxypropyl methylcellulose, and 60g of microcrystalline fiber Add Su PH101 to the wet granulator and mix evenly, then add an appropriate amount of aqueous solution to make a suitable soft material, stirring speed 400rpm, chopping speed 400rpm; extrude the soft material and spheronize to obtain wet skeleton pellets, extrusion speed 30rpm, spheronize The speed is 1000pm, the spheronization time is 5 minutes, and the wet pellet core is obtained; the wet pellet is dried in a fluidized bed for 10 minutes, and sieved to obtain a 20-40 mesh pellet core; weigh 20g Eudragit RS100, 4g triethyl citrate , 4g povidone k30, 10g magnesium stearate are dispersed in 90% ethanol, stir evenly, and preparation concentration is 5% coating liquid; Gained contains pill core coatin...

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Abstract

The invention relates to an epigallocatechin gallate sustained-release capsule and a preparation method thereof, and belongs to the technical field of sustained-release preparations. The epigallocatechin gallate sustained-release capsule is obtained by filling a sustained-release pellet, wherein the sustained-release pellet is composed of a drug-containing pellet core and a coating layer, and the drug-containing pellet core comprises epigallocatechin gallate, a synergist, a filler and a sustained-release skeleton material; the coating layer comprises a sustained-release film-forming material, a plasticizer, a pore-foaming agent and an anti-sticking agent; and the sustained-release pellet consists of a plurality of small unit pellets and is a skeleton type and film control type dual-combined sustained-release capsule. The sustained-release capsule is stable in quality and slow in drug release, the safety, effectiveness and compliance of the drug are remarkably improved, and the preparation process is simple and suitable for large-scale production.

Description

technical field [0001] The invention relates to an epigallocatechin gallate sustained-release capsule and a preparation method thereof, belonging to the technical field of sustained-release preparations. Background technique [0002] Green tea extract is the active ingredient extracted from green tea leaves, mainly including tea polyphenols (catechins), caffeine, aromatic oils, water, minerals, pigments, carbohydrates, proteins, amino acids, vitamins, etc. [0003] Tea polyphenols have the functions of anti-oxidation, scavenging free radicals, etc., significantly reducing the serum total cholesterol, triglyceride, and low-density lipoprotein cholesterol levels in hyperlipidemia, and at the same time have the effect of restoring and protecting vascular endothelial function. The hypolipidemic effect of tea polyphenols is also one of the main reasons why tea can make obese people lose weight without rebounding. [0004] The anti-tumor effect of tea polyphenols has been recogni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/52A61K47/38A61K47/32A61K47/22A61K47/12A61K31/353A61P39/06A61P3/06A61P9/14A61P3/04A61P35/00
CPCA61K9/5047A61K9/5026A61K9/5089A61K47/38A61K47/32A61K47/22A61K47/12A61K31/353A61P39/06A61P3/06A61P9/14A61P3/04A61P35/00
Inventor 赵汉玺朱婉琦邢力刚
Owner AFFILIATED CANCER HOSPITAL OF SHANDONG FIRST MEDICAL UNIV SHANDONG CANCER INST (SHANDONG CANCER HOSPITAL)
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