Oral preparation containing andrographolide and preparation method thereof

Abstract

The invention relates to an oral preparation containing andrographolide and a preparation method thereof, belonging to the field of medicines. The oral preparation containing andrographolide is in dosage forms of enteric-coated granules, enteric-coated tablets, enteric-coated capsules and enteric-coated dispersible tablets which are prepared by mixing andrographolide and pharmaceutically acceptable auxiliary materials. The prepared oral preparation can reduce incidence of adverse reactions and side effects thereof and improve the medication safety while ensuring the therapeutic effect, and uses the andrographolide more widely.

Description

technical field

[0001] The invention relates to an oral preparation containing Yanhuning and a preparation method thereof, belonging to the field of medicine. Background technique

[0002] Yanhuning is a dehydrated andrographolide potassium half-ester succinate potassium sodium salt extracted from the traditional Chinese medicine Andrographis paniculata through esterification, dehydration and salt formation. Its chemical name is 14-dehydroxy-11,12- Potassium sodium salt of didehydroandrographolide-3,19-disuccinate half ester monohydrate. Yanhuning can inhibit early capillary permeability increase and inflammatory exudation and edema, can specifically excite the pituitary-adrenal cortex function, promote the release of ACTH, and increase the biosynthesis of ACTH in the anterior pituitary; The effect of various viruses such as viruses, influenza viruses, respiratory viruses, etc. Animal experiments have anti-early and middle-pregnancy effects. It has heat-clearing, detoxify...

Examples

Embodiment 1

[0055] Embodiment 1 prepares enteric-coated granules

[0056] prescription:

[0057]

[0058] Preparation:

[0059] Coating layer formula: polyacrylic acid resin 200g, ethyl cellulose 100g, polyethylene glycol 5g.

[0060] Color coat formula: 5% polyvinylpyrrolidone (PVP) solution 40g-200g, sunset yellow 1-2g, simple syrup 10-100g.

[0061] After mixing the raw and auxiliary materials of the prescription amount evenly, the soft material is made. Extrusion-spheronization pellets are made into pellets with a diameter of 0.1mm to 2.5mm. The extrusion speed is 1080r / min, the spheronization speed is 960r / min, and the spheronization time is 5min. Drug pellets, after drying in a fluidized bed, screen 30 mesh to 40 mesh pellets for coating, use polyacrylic resin 200g, ethyl cellulose 100g, polyethylene glycol 5g solution to coat the enteric coating layer, 5% polyethylene 40g-200g of pyrrolidone (PVP) solution, 1-2g of sunset yellow, 10-100g of simple syrup, coated with a color ...

Embodiment 2

[0062] Embodiment 2 prepares enteric-coated tablet

[0063] prescription:

[0064]

[0065] Preparation:

[0066] Coating layer formula: polyacrylic acid resin 65g, ethyl cellulose 35g, polyethylene glycol 1.7g.

[0067] Color coat formula: 5% polyvinylpyrrolidone (PVP) solution 40g-200g, sunset yellow 1-2g.

[0068] Pass Yanhuning, microcrystalline cellulose, and pregelatinized starch through a 80-mesh sieve, mix evenly, add an appropriate amount of 95% ethanol to make a soft material, pass through a 20-mesh sieve for granulation, dry at 60°C for 1 hour, and pass through a 18-mesh sieve granules, add CMS-Na, micropowder silica gel, mix evenly, and then use a die to press into tablets, use polyacrylic resin 65g, ethyl cellulose 35g, polyethylene glycol 1.7g solution to coat the enteric coating layer, 5% polyvinylpyrrolidone (PVP) solution 40g~200g, sunset yellow 1~2g.

[0069] Each tablet contains 40mg of the main drug Yanhuning.

Embodiment 3

[0070] Embodiment 3 prepares enteric-coated tablet

[0071] prescription:

[0072]

[0073] Preparation:

[0074] Coating layer formula: polyacrylic acid resin 65g, ethyl cellulose 35g, polyethylene glycol 1.7g.

[0075] Color coat formula: 5% polyvinylpyrrolidone (PVP) solution 40g-200g, sunset yellow 1-2g.

[0076] After mixing the raw and auxiliary materials of the prescription amount evenly, the soft material is made. Extrusion-spheronization pellets are made into pellets with a diameter of 0.1mm to 2.5mm. The extrusion speed is 1080r / min, the spheronization speed is 960r / min, and the spheronization time is 5min. Drug pellets, after drying in a fluidized bed, screen the pellets with 30 to 40 meshes and coat them with polyacrylic acid resin 65g, ethyl cellulose 35g, polyethylene glycol 1.7g solution to coat the enteric coating layer, 5% polyethylene 40g-200g of pyrrolidone (PVP) solution, 1-2g of sunset yellow, coated with a color coating layer, and the obtained pell...

technical field

[0001] The invention relates to an oral preparation containing Yanhuning and a preparation method thereof, belonging to the field of medicine. Background technique

[0002] Yanhuning is a dehydrated andrographolide potassium half-ester succinate potassium sodium salt extracted from the traditional Chinese medicine Andrographis paniculata through esterification, dehydration and salt formation. Its chemical name is 14-dehydroxy-11,12- Potassium sodium salt of didehydroandrographolide-3,19-disuccinate half ester monohydrate. Yanhuning can inhibit early capillary permeability increase and inflammatory exudation and edema, can specifically excite the pituitary-adrenal cortex function, promote the release of ACTH, and increase the biosynthesis of ACTH in the anterior pituitary; The effect of various viruses such as viruses, influenza viruses, respiratory viruses, etc. Animal experiments have anti-early and middle-pregnancy effects. It has heat-clearing, detoxify...

Examples

Embodiment 1

[0055] Embodiment 1 prepares enteric-coated granules

[0056] prescription:

[0057]

[0058] Preparation:

[0059] Coating layer formula: polyacrylic acid resin 200g, ethyl cellulose 100g, polyethylene glycol 5g.

[0060] Color coat formula: 5% polyvinylpyrrolidone (PVP) solution 40g-200g, sunset yellow 1-2g, simple syrup 10-100g.

[0061] After mixing the raw and auxiliary materials of the prescription amount evenly, the soft material is made. Extrusion-spheronization pellets are made into pellets with a diameter of 0.1mm to 2.5mm. The extrusion speed is 1080r / min, the spheronization speed is 960r / min, and the spheronization time is 5min. Drug pellets, after drying in a fluidized bed, screen 30 mesh to 40 mesh pellets for coating, use polyacrylic resin 200g, ethyl cellulose 100g, polyethylene glycol 5g solution to coat the enteric coating layer, 5% polyethylene 40g-200g of pyrrolidone (PVP) solution, 1-2g of sunset yellow, 10-100g of simple syrup, coated with a color ...

Embodiment 2

[0062] Embodiment 2 prepares enteric-coated tablet

[0063] prescription:

[0064]

[0065] Preparation:

[0066] Coating layer formula: polyacrylic acid resin 65g, ethyl cellulose 35g, polyethylene glycol 1.7g.

[0067] Color coat formula: 5% polyvinylpyrrolidone (PVP) solution 40g-200g, sunset yellow 1-2g.

[0068] Pass Yanhuning, microcrystalline cellulose, and pregelatinized starch through a 80-mesh sieve, mix evenly, add an appropriate amount of 95% ethanol to make a soft material, pass through a 20-mesh sieve for granulation, dry at 60°C for 1 hour, and pass through a 18-mesh sieve granules, add CMS-Na, micropowder silica gel, mix evenly, and then use a die to press into tablets, use polyacrylic resin 65g, ethyl cellulose 35g, polyethylene glycol 1.7g solution to coat the enteric coating layer, 5% polyvinylpyrrolidone (PVP) solution 40g~200g, sunset yellow 1~2g.

[0069] Each tablet contains 40mg of the main drug Yanhuning.

Embodiment 3

[0070] Embodiment 3 prepares enteric-coated tablet

[0071] prescription:

[0072]

[0073] Preparation:

[0074] Coating layer formula: polyacrylic acid resin 65g, ethyl cellulose 35g, polyethylene glycol 1.7g.

[0075] Color coat formula: 5% polyvinylpyrrolidone (PVP) solution 40g-200g, sunset yellow 1-2g.

[0076] After mixing the raw and auxiliary materials of the prescription amount evenly, the soft material is made. Extrusion-spheronization pellets are made into pellets with a diameter of 0.1mm to 2.5mm. The extrusion speed is 1080r / min, the spheronization speed is 960r / min, and the spheronization time is 5min. Drug pellets, after drying in a fluidized bed, screen the pellets with 30 to 40 meshes and coat them with polyacrylic acid resin 65g, ethyl cellulose 35g, polyethylene glycol 1.7g solution to coat the enteric coating layer, 5% polyethylene 40g-200g of pyrrolidone (PVP) solution, 1-2g of sunset yellow, coated with a color coating layer, and the obtained pell...

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