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Azithromycin capsule and preparation method thereof

A technology of azithromycin and capsules, which is applied in the field of pharmaceutical preparations, can solve the problems of fragmentation, large difference in weight, and poor powder fluidity, and achieve the effects of high yield, less over-grinding, and good fluidity

Inactive Publication Date: 2018-01-16
合肥远志医药科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the direct compression method faces many challenges. 1. Very picky about the type and dosage of active ingredients and excipients; 2. The fluidity of the powder is poor; 3. The weight difference is large; 4. It is easy to cause splits

Method used

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  • Azithromycin capsule and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Take by weighing 1.309kg of azithromycin raw material, 0.266kg of microcrystalline cellulose, 0.079kg of crospovidone, and 0.029kg of magnesium stearate, mix with a three-dimensional mixer for 5min, granulate with a dry granulator, and weigh 0.0045kg Sodium lauryl sulfate is mixed with the granules for 3 minutes, and the filling agent is prepared. Pass through a 20-mesh sieve to obtain granules. The granules have good fluidity. Fill gelatin capsules with No. 1 gelatin, and control the filling volume to 340 mg.

[0016] name

Embodiment 2

[0018] Take by weighing 1.311kg of azithromycin raw material, 0.265kg of microcrystalline cellulose, 0.077kg of crospovidone, and 0.029kg of magnesium stearate, mix with a three-dimensional mixer for 5min, granulate with a dry granulator, and weigh 0.005kg Sodium lauryl sulfate is mixed with the granules for 3 minutes, and the filling agent is prepared. Pass through a 20-mesh sieve to obtain granules. The granules have good fluidity. Fill gelatin capsules with No. 1 gelatin, and control the filling volume to 340 mg.

Embodiment 3

[0020] Take by weighing 1.309kg of azithromycin raw material, 0.267kg of microcrystalline cellulose, 0.074kg of crospovidone, and 0.029kg of magnesium stearate, mix with a three-dimensional mixer for 5min, and granulate with a dry granulator, weighing 0.0042kg Sodium lauryl sulfate is mixed with the granules for 3 minutes, and the filling agent is prepared. Pass through a 20-mesh sieve to obtain granules. The granules have good fluidity. Fill gelatin capsules with No. 1 gelatin, and control the filling volume to 340 mg.

[0021] Described microcrystalline cellulose can adopt any one in PH-101, PH-102, PH-103, PH-105, PH-F20, PH-301, PH-302, KG-801, preferably PH302, microcrystalline fiber Prime 302 is free-flowing extremely fine short rod-like or powdery particles, white or near-white in color, odorless, tasteless, and has the characteristics of good fluidity, rapid disintegration and dissolution. The above-mentioned microcrystalline cellulose PH-302 It is an excellent new typ...

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Abstract

An azithromycin capsule and a preparation method thereof are disclosed. The azithromycin capsule comprises a capsule filling material and a capsule shell, the capsule filling material comprises the following raw materials in parts by mass: 245 to 255 parts of azithromycin dihydrate (in terms of afatinib), 45 to 50 parts of microcrystalline cellulose, 0.6 to 1.0 part of sodium dialkyl sulfate, 12 to 15 parts of polyvinylpolypyrrolidone and 5 to 6 parts of magnesium stearate. Podwer material is directly prepared into granules by use of crystal water in the material, the azithromycin capsule canbe continuously produced, the azithromycin capsule has the advantages of uniform compression distribution, good granule stability, good fluidity, less over crushing, higher yield and the like, and isconvenient in mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. Specifically, the present invention relates to azithromycin capsule and its preparation method. Background technique [0002] Azithromycin, its chemical name is: (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3-C-methyl-3-O -methyl-α-L-nucleo-hexapyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl -11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xyl-hexapyranosyl]oxy]-1-oxa-6-azacyclopentadecane -15-ketone, its chemical structural formula is: molecular formula: C38H72N2O12, molecular weight: 749.00. The chemical structural formula is: [0003] [0004] Azithromycin is a macrolide antibiotic and is suitable for the treatment of acute pharyngitis, acute tonsillitis caused by Streptococcus pyogenes, acute bronchitis caused by sensitive bacteria, acute exacerbation of chronic bronchitis, and pneumonia caused by Streptococcus pneumoniae, influenza bacillus ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/7052A61K47/38A61K47/32A61P31/04
Inventor 李鹏白中稳
Owner 合肥远志医药科技开发有限公司
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