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A kind of preparation method of azithromycin capsule

A technology for azithromycin and capsules, applied in the field of preparation of azithromycin capsules, can solve the problems of unstable granulation, uneven mixing of azithromycin granules, easily destroyed crystal form, etc. uneven mixing effect

Active Publication Date: 2022-02-18
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] In order to solve the above technical problems, the present invention provides a preparation method of azithromycin capsules. The preparation method provided by the present invention overcomes the problems of unstable and easily destroyed crystal forms of traditional wet granulation, and at the same time solves the problems of azithromycin granules caused by dry granulation. Problems such as uneven mixing

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  • A kind of preparation method of azithromycin capsule
  • A kind of preparation method of azithromycin capsule
  • A kind of preparation method of azithromycin capsule

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Embodiment 1

[0032] The present embodiment provides a kind of preparation method of azithromycin, and this preparation method comprises the following steps:

[0033] (1) Weigh 250.0g azithromycin, 80.0g microcrystalline cellulose, 2.0g sodium lauryl sulfate, and sieve the microcrystalline cellulose with a 40-mesh sieve to remove caking;

[0034] (2) Add azithromycin, microcrystalline cellulose, and sodium lauryl sulfate into a wet mixing granulator and stir for 3 minutes under the condition of 35 r / min;

[0035] (3) Add 42.0g of purified water into the wet granulator, cut for 55s under the condition of 50r / min, and make soft material;

[0036] (4) Add the soft materials into the oscillating granulator for granulation to obtain wet granules, and place the wet granules in a fluidized bed dryer to dry, the drying temperature is 45±5°C, and the drying time is 10min;

[0037] (5) The dried particles are sized by a 0.75mm aperture sieve;

[0038] (6) Add 6.0 g of magnesium stearate to the dri...

Embodiment 2

[0040] The present embodiment provides a kind of preparation method of azithromycin, and this preparation method comprises the following steps:

[0041] (1) Weigh 250.0g azithromycin, 50.0g microcrystalline cellulose, and 1.5g sodium lauryl sulfate, and remove the agglomeration by sieving the microcrystalline cellulose with a 40-mesh sieve;

[0042] (2) Add azithromycin, microcrystalline cellulose, and sodium lauryl sulfate into a wet mixing granulator and stir for 3 minutes under the condition of 20-50r / min;

[0043] (3) Add 37.7g of purified water into the wet granulator, cut for 55s under the condition of 45r / min, and make soft material;

[0044] (4) Add the soft materials into the oscillating granulator for granulation to obtain wet granules, and place the wet granules in a fluidized bed dryer to dry, the drying temperature is 45±5°C, and the drying time is 10min;

[0045] (5) The qualified particles after drying are sized by a sieve with an aperture of 0.75mm;

[0046]...

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Abstract

The invention provides a preparation method of azithromycin capsules. The preparation method of the azithromycin capsule comprises the following steps: (1) weighing azithromycin, microcrystalline cellulose, sodium lauryl sulfate; (2) putting azithromycin, microcrystalline cellulose, sodium lauryl sulfate into wet mixing Mix uniformly in the granulator to obtain mixed powder; (3) add purified water to the wet granulator and mix evenly to make a soft material; (4) add the soft material to a swing granulator to granulate, dry, and the resulting The drying temperature is 45±5°C, and the drying time is 9-11min; (5) the dried granules are granulated by a swing granulator; (6) magnesium stearate is added to the dried granules Mix evenly, pack into the capsule shell, and obtain the azithromycin capsule; the preparation method of the azithromycin capsule provided by the present invention overcomes the problems of instability of traditional wet granulation and easy destruction of the crystal form.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a preparation method of azithromycin capsules. Background technique [0002] Azithromycin C 38 h 72 N 2 o 12 , also known as azithromycin, azithromycin, is a white powder, antibiotics belonging to macrolides, discovered in 1980, launched in 1981, azithromycin can treat many bacterial infections, including otitis media, streptococcus Pharyngitis, pneumonia, traveler's diarrhea and other conditions such as gastroenteritis, can also treat many sexually transmitted diseases, including chlamydial infection and gonorrhea, and can also be used to treat malaria. Its preparations are capsules, tablets, dry suspension, etc. dosage forms. [0003] The existing azithromycin capsule preparations mostly use dry granulation, which often leads to inability to better wet the material and uneven mixing of granules, so the product has poor dissolution rate, low absorption rate, and m...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/38A61K47/20A61K31/7052A61P31/04
CPCA61K9/1682A61K9/1652A61K9/1617A61K31/7052A61P31/04
Inventor 宋更申李同进安百锋张婷婷
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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