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Enteric-coated kitasamycin sustained release microspheres and preparation method thereof

A technology of guitarmycin and sustained-release microspheres, applied in the field of enteric-coated guitarmycin sustained-release microspheres and preparation thereof, can solve the problem of large batch-to-batch variation of micropellets, large fluctuation of blood drug concentration level, and destruction of guitarmycin. The problem of large amount and other problems can be achieved to achieve the effect of small differences between products and small fluctuations in blood drug concentration levels.

Inactive Publication Date: 2017-01-04
甘肃瑞和祥生物科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides an enteric-coated kitamaycin sustained-release microsphere and a preparation method thereof, which solve the problem of large amount of damage of kitamaycin in the gastric acid environment, short release time of the microsphere in the intestinal tract, and large fluctuation of blood drug concentration in the prior art And the problem of large differences between pellet batches

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] (1) Weigh polyethylene glycol 4000 by weight percentage and add it into a high-speed stirrer, heat to completely melt the melting agent, and the heating temperature is 55°C~105°C;

[0041] (2) Weigh kitasamycin by weight percentage, add it to a high-speed mixer, and mix kitasarmycin with the completely melted polyethylene glycol 4000 obtained in step (1), so that kitasarmycin is dissolved in polyethylene glycol 4000 Disperse evenly, the speed of the high-speed agitator is 1000r / min~2000r / min, the stirring time is 30min~60min, then cool the uniformly mixed kitasarmycin mixture to room temperature to form a solid dispersion of kitasarmycin, and pulverize the solid dispersion , select 40 mesh ~ 60 mesh kitasamycin solid dispersion fine powder;

[0042] (3) Add microcrystalline cellulose weighed by weight percentage to the fine powder of kitasarmycin solid dispersion obtained in step (2), and then add water weighed by weight percentage to make kitasarmycin soft material;

...

Embodiment 2

[0047] (1) Weigh polyethylene glycol 4000 by weight percentage and add it into a high-speed stirrer, heat to completely melt the melting agent, and the heating temperature is 55°C~105°C;

[0048] (2) Weigh kitasamycin by weight percentage, add it to a high-speed mixer, and mix kitasarmycin with the completely melted polyethylene glycol 4000 obtained in step (1), so that kitasarmycin is dissolved in polyethylene glycol 4000 Disperse evenly, the speed of the high-speed agitator is 1000r / min~2000r / min, the stirring time is 30min~60min, then cool the uniformly mixed kitasarmycin mixture to room temperature to form a solid dispersion of kitasarmycin, and pulverize the solid dispersion , select 40 mesh ~ 60 mesh kitasamycin solid dispersion fine powder;

[0049] (3) adding lactose weighed by weight percentage to the kitasarmycin solid dispersion fine powder obtained in step (2), and then adding water weighed by weight percentage to make kitasarmycin soft material;

[0050] (4) The ki...

Embodiment 3

[0054] (1) Weigh polyethylene glycol 6000 by weight percentage and add it into a high-speed stirrer, heat to completely melt the melting agent, and the heating temperature is 55°C~105°C;

[0055] (2) Weigh kitasamycin by weight percentage, add it to a high-speed mixer, and mix kitasarmycin with the completely melted polyethylene glycol 6000 obtained in step (1), so that kitasarmycin is dissolved in polyethylene glycol 6000 Disperse evenly, the speed of the high-speed agitator is 1000r / min~2000r / min, the stirring time is 30min~60min, then cool the uniformly mixed kitasarmycin mixture to room temperature to form a solid dispersion of kitasarmycin, and pulverize the solid dispersion , select 40 mesh ~ 60 mesh kitasamycin solid dispersion fine powder;

[0056] (3) adding lactose weighed by weight percentage to the kitasarmycin solid dispersion fine powder obtained in step (2), and then adding water weighed by weight percentage to make kitasarmycin soft material;

[0057] (4) The ...

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Abstract

The invention relates to enteric-coated kitasamycin sustained release microspheres and a preparation method thereof. The problems that in the prior art, the destruction amount of kitasamycin in a gastric acid environment is high, the release time of microspheres in the intestinal tract is short, blood medicine concentration level fluctuation is great, and the difference among batches of pellets is great are solved. The preparation method comprises the steps that kitasamycin is uniformly mixed in a melting agent, a kitasamycin soft material is prepared from a bonding agent and filling auxiliary materials, microspheres are prepared and then coated with two layers, and preparation of the enteric-coated kitasamycin sustained release microspheres is completed. According to an enteric-coated kitasamycin sustained release microsphere composition and the enteric-coated kitasamycin sustained release microspheres and the preparation method thereof, the destroyed amount in the gastric acid environment does not exceed 5%, little blood medicine concentration level fluctuation is generated, the release amount per hour is about 8%-12% of the labeled amount, little difference among products is generated, and the quality is stable.

Description

technical field [0001] The invention relates to enteric-coated kitamaycin sustained-release microspheres and a preparation method thereof, belonging to the technical field of veterinary drug preparation. Background technique [0002] Kitamycin has a strong inhibitory effect on Gram-positive bacteria, some Gram-negative bacteria, Bacteria, Rickettsia, Mycoplasma and its Leptospira. [0003] At present, the main preparation forms of kitasarmycin are: [0004] (1) Powder: Jitarmycin is simply mixed with auxiliary materials. Due to the specific gravity of the materials and other problems, the mixing is uneven, and stratification will occur during transportation and storage. The bitter taste affects the feed intake of animals, and it is easily destroyed in the stomach. After taking it, the metabolism is fast, and the effect of antibacterial and growth promotion is poor. [0005] (2) Granules: Kitamycin is mixed with suitable excipients and granulated, which cannot cover up the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/7048A61K47/34A61K47/38A61K47/32A61P31/04
CPCA61K9/0002A61K9/5026A61K9/5042A61K31/7048
Inventor 李竹田刚王莉邱启强赵强
Owner 甘肃瑞和祥生物科技有限公司
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