Berberine and berberine forming salt enteric micropellet, preparation and application thereof

A technology of enteric-coated pellets and berberine, which is applied in the field of preparation of berberine and its enteric-coated pellets that can form salt, can solve the problems of gastric mucosa irritation, etc., so as to increase the compliance of use, reduce losses, Reduce the effect of stimulation

Inactive Publication Date: 2018-10-23
INST OF MATERIA MEDICA CHINESE ACAD OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] Based on the above research, in order to overcome the defects of the prior art, the present invention provides a preparation method and new application for researching berberine and its salty enteric-coated pellets, effectively solving the problem of berberine and its salty taste Bitter, irritating to gastric mucosa and other problems

Method used

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  • Berberine and berberine forming salt enteric micropellet, preparation and application thereof
  • Berberine and berberine forming salt enteric micropellet, preparation and application thereof
  • Berberine and berberine forming salt enteric micropellet, preparation and application thereof

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Experimental program
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Embodiment 1-8

[0046] Embodiment 1-8 (embodiment one to eight):

Embodiment 1-2

[0048]

[0049]

[0050] The preparation method of embodiment 1-2:

[0051] 1). Add polyethylene glycol in boiling water, and add active drug ingredients while stirring; take another purified water to dissolve surfactant and adhesive evenly, add active drug and PEG boiling water solution while stirring, and stir until dispersed evenly , and keep the temperature of the mixed solution higher than 60°C to obtain the drug-containing layer coating solution. Put the blank core in a fluidized bed for coating, fan frequency 16-20Hz, air inlet temperature 35-70°C, exhaust air temperature 25-30°C, material temperature 25-60°C, atomization pressure 1.5-2bar, pack Continue to dry for 2-5 minutes after the coat is completed.

[0052] 2). Weigh an appropriate amount of retarder and adhesive, add appropriate amount of purified water and stir to fully swell, add appropriate amount of purified water with anti-adhesive agent, stir slowly for 3-5min, mix the two solutions, and obtain the ...

Embodiment 3-8

[0057]

[0058]

[0059] The preparation method of embodiment 3-8:

[0060] 1). Preparation of drug-containing layer pellets

[0061] Take part of the hot purified water and add dispersant and active pharmaceutical ingredients to it while stirring to make it fully dissolved and dispersed; take another purified water to dissolve the surfactant and add the binder to obtain a clear solution. After the dispersion is uniform, add it while stirring Heat the active drug component solution, stir until uniformly dispersed, and obtain the drug-containing layer coating solution. Place the blank core in a fluidized bed for coating, fan frequency 16-20Hz, air inlet temperature 35-50°C, exhaust air temperature 25-30°C, material temperature 25-30°C, atomization pressure 1.5-2bar, pack Continue to dry for 2-5 minutes after the coat is completed. The active pharmaceutical ingredient is berberine and / or a salt that can be formed by berberine.

[0062] 2). Preparation of isolation layer...

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Abstract

The invention discloses berberine and a berberine forming salt enteric micropellet, a preparation method and application thereof in preparing medicines for treating various metabolic diseases such ashyperglycemia, hyperlipemia, obesity and fatty liver. The berberine forming salt enteric micropellet includes a blank pellet core, a drug layer, a barrier layer, an enteric layer, and a protective layer from the inside to the outside. The drug layer includes the berberine and / or a salt which can be formed by the berberine, a dispersing agent, a binder, and a surfactant. The preparation method of the berberine forming salt enteric micropellet is a fluidized bed air suspension method or a droplet spray drying method. The berberine forming salt enteric micropellet prepared by the method can coverthe bitter taste of the berberine, reduces the simulating effect of the drug on gastric mucosa, reduces the adverse reaction of clinical use, improves the compliance of patients, is hardly released in stomachs, is rapidly released after entering the intestinal tract, has high bioavailability, and is suitable for the treatment of the hyperglycemia, the hyperlipemia, the obesity, the fatty liver and other metabolic diseases.

Description

technical field [0001] The present invention relates to the field of pharmaceutical preparations and applications. Specifically, a method for preparing berberine and enteric-coated salt pellets is designed, which is applied to the treatment of metabolic diseases such as hyperglycemia, hyperlipidemia, obesity and fatty liver. . Background technique [0002] Berberine (BBR) has a long history of clinical application in my country. In the past, it was mainly used as an antibacterial drug to treat bacterial diarrhea, and its efficacy and safety have been generally recognized. Through the screening of traditional Chinese medicine monomers, we found for the first time that berberine can up-regulate the expression of low-density lipoprotein receptor (LDLR) in hepatocytes, and has a clear blood lipid-lowering effect in vivo. More subsequent studies also proved the therapeutic effect of berberine on metabolic diseases such as hyperlipidemia, hyperglycemia, obesity and fatty liver. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/4375A61K47/32A61K47/10A61P3/06A61P3/10A61P3/04A61P1/16
CPCA61K9/5026A61K9/5031A61K9/5047A61K9/5078A61K9/5089A61K31/4375A61P1/16A61P3/04A61P3/06A61P3/10
Inventor 蒋建东王璐璐韩燕星郑稳生
Owner INST OF MATERIA MEDICA CHINESE ACAD OF MEDICAL SCI
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