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Preparing method of azithromycin capsule

A technology for azithromycin and capsules, which is applied in the field of preparation of azithromycin capsules, can solve problems such as easily destroyed crystal forms, uneven mixing of azithromycin granules, and unstable granulation. overcoming unstable effects

Active Publication Date: 2019-10-01
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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  • Preparing method of azithromycin capsule
  • Preparing method of azithromycin capsule
  • Preparing 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 0.75 mm;

[0046...

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Abstract

The invention provides a preparing method of an azithromycin capsule. The method includes the following steps of firstly, weighing azithromycin, microcrystalline cellulose and lauryl sodium sulfate; secondly, putting the azithromycin, microcrystalline cellulose and lauryl sodium sulfate into a wet-method mixing granulator to be evenly mixed to prepare mixed powder; thirdly, adding purified water into the wet-method granulator to be evenly mixed to prepare a soft material; fourthly, adding the soft material into a swing granulator to be granulated and dried, wherein the drying temperature is 45+ / 5 DEG C, and the drying time is 9-11 minutes; fifthly, rounding dried granules through the swing granulator; sixthly, adding magnesium stearate to the dried granules to be evenly mixed, and fillinga capsule shell with the mixture to obtain the azithromycin capsule. By means of the preparing method of the azithromycin capsule, the problems are solved that traditional wet-method granulating is not stable and the crystal type is prone to damage.

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 Applications(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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