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Azithromycin sustained-release pellet capsule and preparation method thereof

A technology for azithromycin and sustained-release pellets, which is applied in the field of azithromycin sustained-release pellets and its preparation, can solve problems such as increased incidence, and achieve the effects of low material loss, reduced side effects, and stable properties

Inactive Publication Date: 2019-10-22
武汉长联来福制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Oral administration of azithromycin causes gastrointestinal adverse effects in a significant number of patients, and the incidence of these side effects increases with increasing dose levels of azithromycin

Method used

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  • Azithromycin sustained-release pellet capsule and preparation method thereof
  • Azithromycin sustained-release pellet capsule and preparation method thereof
  • Azithromycin sustained-release pellet capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Ball core:

[0034] Prescription Composition Prescription Amount

[0035] Azithromycin 500g

[0036] Croscarmellose Sodium 5g

[0037] Lactose 62.5g

[0038] Macrogol 6000 5g

[0039] Appropriate amount of purified water

[0040] Slow-release coating:

[0041] Prescription Composition Prescription Amount

[0042] Eurdragit RL 30D 35g

[0043] Triethyl citrate 4g

[0044] Talc powder 5g

[0045] Appropriate amount of purified water

[0046] Coating weight gain 20%~25%

[0047] Make 1000 capsules.

[0048] Preparation of pellets: Pass the azithromycin raw material through a 100-mesh sieve, weigh the prescribed amount of azithromycin, croscarmellose sodium, and lactose, mix them evenly in an extruder, and use polyethylene glycol 6000 aqueous solution for bonding To make wet and soft materials, put the soft materials in an extruder to extrude pellets. The sieve aperture is preferably 1mm, and the extrusion speed is 20~30rpm. 1000rpm. The spheronized pell...

Embodiment 2

[0052] Ball core:

[0053] Prescription Composition Prescription Amount

[0054] Azithromycin 500g

[0055] Croscarmellose Sodium 31.25g

[0056] Lactose 5g

[0057] Macrogol 6000 5g

[0058] Appropriate amount of purified water

[0059] Slow-release coating:

[0060] Prescription Composition Prescription Amount

[0061] Eurdragit RL 30D 35g

[0062] Triethyl citrate 4g

[0063] Talc powder 5g

[0064] Appropriate amount of purified water

[0065] Coating weight gain 20%~25%

[0066] Make 1000 capsules.

[0067] Preparation of pellets: Pass the azithromycin raw material through a 100-mesh sieve, weigh the prescribed amount of azithromycin, croscarmellose sodium, and lactose, mix them evenly in an extruder, and use polyethylene glycol 6000 aqueous solution for bonding To make wet and soft materials, put the soft materials in an extruder to extrude pellets. The sieve aperture is preferably 1mm, and the extrusion speed is 20~30rpm. 1000rpm. The spheronized pel...

Embodiment 3

[0071] Ball core:

[0072] Prescription Composition Prescription Amount

[0073] Azithromycin 500g

[0074] Croscarmellose Sodium 5g

[0075] Lactose 33.75g

[0076] Macrogol 6000 18.125g

[0077] Appropriate amount of purified water

[0078] Slow-release coating:

[0079] Prescription Composition Prescription Amount

[0080] Eurdragit RL 30D 35g

[0081] Triethyl citrate 4g

[0082] Talc powder 5g

[0083] Appropriate amount of purified water

[0084] Coating weight gain 20%~25%

[0085] Make 1000 capsules.

[0086] Preparation of pellets: Pass the azithromycin raw material through a 100-mesh sieve, weigh the prescribed amount of azithromycin, croscarmellose sodium, and lactose, mix them evenly in an extruder, and use polyethylene glycol 6000 aqueous solution for bonding To make wet and soft materials, put the soft materials in an extruder to extrude pellets. The sieve aperture is preferably 1mm, and the extrusion speed is 20~30rpm. 1000rpm. The spheronize...

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Abstract

The invention relates to an azithromycin sustained-release pellet capsule and a preparation method thereof. A sustained-release coating film of the pellet is a film forming material using one or a combination of an ethyl cellulose aqueous dispersion, ethyl acrylate-methacrylic acid ester and a polyvinyl acetate copolymer, a plasticizer is one or a combination of triethyl citrate, polyethylene glycol, and propylene glycol, and an anti-adhesive employs powdered steatile. a disintegrating agent in the core of the pellet is prepared by cross linked sodium carboxymethyl cellulose, which accounts for 1% to 5% of the core of the pellet, and a filler is one or a combination of microcrystalline cellulose and lactose, which accounts for 1% to 10% of the core of the pellet, a binder is one or severalcombinations of polyethylene glycol and povidone, which accounts for 1% to 5% of the core of the pellet, and the weight gain of a coating is preferably 20% to 35%. The azithromycin sustained-releasepellet capsule of the invention has stable quality, and can continuously release a drug for a long time to achieve the long-acting effect, which avoids excessive fluctuation of the blood drug concentration, and reduces the side effects.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an azithromycin sustained-release pellet capsule and a preparation method thereof. Background technique [0002] Azithromycin (azithromycin) is a broad-spectrum antibiotic derived from erythromycin A. Deoxy-3-C-methyl-3-O-methyl-a-L-nucleo-hexapyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8 ,10,12,14-Heptamethyl-11[[3,4,6-trideoxy-3(dimethyl)-β-D-xyl-hexapyranosyl]oxy]-1-oxa- 6-Azacyclopentadecane-15-one. Its structural formula is: [0003] [0004] Azithromycin was first listed in the United States by Pfizer in 1991. It is known as the "blockbuster" of antibiotic drugs in the 20th century. It is the first fifteen-membered ring macrolide derivative developed by Croatian Priva Pharmaceuticals. , which has a broader antibacterial spectrum than erythromycin. By inhibiting the synthesis of bacterial ribosomal 50S subunit protein, azithromycin ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/7052A61K47/32A61P31/04
CPCA61K9/5026A61K31/7052A61P31/04
Inventor 王秉庆刘大鹏赵秀林王晓星
Owner 武汉长联来福制药股份有限公司
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