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Medicine granule, preparation method thereof, and preparation containing same

A drug and particle technology, which is applied to medical preparations containing active ingredients, pharmaceutical formulas, pill delivery, etc., can solve problems such as bad taste, large dosage, and low content of drug particles, and achieve good taste masking effect and high drug content. High, good taste-masking effect

Inactive Publication Date: 2009-10-07
SHANGHAI INST OF PHARMA IND +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is to overcome the defects that the existing drug particles have low content, are not suitable for the preparation of pharmaceutical preparations with large dosage, and especially have bad taste at the same time, and provide a drug with higher drug content. Drug particles with strong hardness, better taste masking effect and smaller particle size, pharmaceutical preparations containing the particles and their preparation methods

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] 300g (75%) of paracetamol (75%), 88g (22%) of lactose, and 2g (0.5%) of micropowdered silica gel were mixed according to the double amount method by the high shear method, placed in a tangential jet fluidized bed, and the frequency of the fan was 27Hz. The air inlet temperature is 30°C, the atomization pressure is 0.25MPa, the rotary speed is 500rpm, the spray speed is 4g / min, the material is heated to 24°C, and 4g / 100ml hydroxypropylmethylcellulose (viscosity is 5cPs) aqueous solution (containing hypromellose Base cellulose 10g (2.5%)) is sprayed on the dry mixture of heating, makes to form drug particle, heats up and dries, promptly obtains acetaminophen drug particle. The drug content of acetaminophen is 75%, the particle size is 80-180 μm, the angle of repose is 28°, the degree of compression is 8%, and the friability is 1.4%. The agent has high tensile strength.

[0045] Following the above preparation steps, in the tangential jet fluidized bed, adopt fan frequenc...

Embodiment 2

[0050] 380g (95%) of ranitidine, 8g (2%) of starch and 0.24g (0.06%) of talcum powder were mixed by the high shear method according to the method of doubling the amount, placed in a tangential jet fluidized bed, and the frequency of the fan was 15Hz. , the air inlet temperature is 35°C, the atomization pressure is 0.15MPa, the turntable speed is 300rpm, the spray speed is 6g / min, the material is heated to 30°C, and 3g / 100ml hydroxypropylmethylcellulose (viscosity is 50cPs) aqueous solution (containing hydroxypropylmethylcellulose) Methyl cellulose 11.76g (2.94%)) is sprayed on the heated dry mixture to form drug particles, which are heated and dried to obtain ranitidine drug particles. The drug content of ranitidine is 95%, the particle size is 60-240 μm, the angle of repose is 38°, the degree of compression is 15%, and the degree of friability is 10%. High tensile strength.

[0051] Following the above preparation steps, in the tangential jet fluidized bed, adopt fan frequen...

Embodiment 3

[0055] 340g (85%) of aspirin, 53g (13.25%) of microcrystalline cellulose and 1g (0.25%) of magnesium stearate were mixed by the high shear method according to the double amount method, placed in a tangential jet fluidized bed, and the fan frequency was used 30Hz, air inlet temperature 35°C, atomization pressure 0.05MPa, turntable speed 120rpm, liquid spray speed 3g / min, material heated to 30°C, 2g / 100ml hydroxypropylmethylcellulose (viscosity 5cPs) aqueous solution (containing hydroxyl Propylmethylcellulose (1.5%) is sprayed onto the heated dry mixture to form drug particles, which are heated and dried; namely, aspirin drug particles are obtained. The content of aspirin is 85%, the particle size is 100~200 μm, the angle of repose is 35°, the degree of compression is 15%, and the degree of friability is 7%. high.

[0056] Following the aforementioned preparation steps, in a tangential jet fluidized bed, adopt fan frequency 30Hz, air inlet temperature 55°C, atomization pressure...

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Abstract

The invention discloses a medicine granule containing the following components by mass percent: 75 to 95 of medicine, 2 to 22 of thinner for pelletization, 0.06t to 0.5 of glidant, and 1.5 to 3.5 of adhesive. The invention also discloses a preparation method thereof and a preparation containing same. The medicine granule has high medicine content, round surface, higher rigidity and smaller grain diameter, can be directly used for tabletting, has less weight increment if being coated and can achieve a better taste masking effect. The method for preparing the medicine granule can simultaneously realize pelletization and coating technologies in a tangent spraying fluidized bed, has simple production steps and high efficiency, and can be applied to mass production.

Description

technical field [0001] The present invention relates to a drug microparticle, its preparation method, and a preparation containing the microparticle. Background technique [0002] Solid dosage forms such as dry suspensions, fine granules and orally disintegrating tablets are especially suitable for the elderly, children and other patients who have difficulty swallowing because of their small unit volume or rapid disintegration in the oral cavity. The above-mentioned dosage forms are usually produced from pharmaceutical microparticles. The drug content contained in the existing drug particles is relatively low, which cannot meet the preparation requirements of drugs with a large dosage. For medicines with large doses and bad taste, this problem is even more serious. It is not enough to cover the bitter taste in the mouth only by adding fillers and flavoring agents with good taste. Coating is a general method of coating. Coating is divided into powder coating and pre-granul...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/20A61K47/38A61K47/36A61K47/34A61K47/32A61K31/167A61K31/192A61K31/196A61K31/341A61K31/4164A61K31/616
Inventor 任麒唐慧敏沈慧凤张慧张开衷李杰孙冠男任瑶吴梦菲
Owner SHANGHAI INST OF PHARMA IND
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