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 hav

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0043] Example 1

[0044] 300g (75%) of acetaminophen, 88g (22%) of lactose and 2g (0.5%) of micronized silica gel were mixed by the high shear method according to the multiplying method, and placed in a tangential jet fluidized bed with a fan frequency of 27 Hz. The inlet air temperature is 30℃, the atomization pressure is 0.25MPa, the rotating speed of the turntable is 500rpm, the spraying speed is 4g / min, the material is heated to 24℃, and the 4g / 100ml hypromellose (viscosity 5cPs) aqueous solution (containing hypromellose) The base cellulose 10g (2.5%) is sprayed on the heated dry mixture to form the drug particles, and the drug particles are heated and dried to obtain the paracetamol drug particles. The content of acetaminophen drug is 75%, the particle size is 80~180μm, the angle of repose is 28°, the compression degree is 8%, and the fragility is 1.4%. The agent has high tensile strength.

[0045] Following the previous preparation steps, in the tangential jet fluidized bed...

Example Embodiment

[0049] Example 2

[0050] 380g (95%) ranitidine, 8g (2%) starch and 0.24g (0.06%) of talc powder were mixed by high-shearing method according to the multiplying method, and placed in a tangential jet fluidized bed with a fan frequency of 15Hz , The inlet air temperature is 35℃, the atomization pressure is 0.15MPa, the rotating speed of the turntable is 300rpm, the spraying speed is 6g / min, the material is heated to 30℃, and the 3g / 100ml hypromellose (viscosity 50cPs) aqueous solution (containing hydroxypropyl) 11.76g (2.94%) of methylcellulose was sprayed on the heated dry mixture to form drug particles, and heated and dried to obtain ranitidine drug particles. The drug content of ranitidine is 95%, the particle size is 60~240μm, the angle of repose is 38°, the compression degree is 15%, and the fragility is 10%. The tablet made of microparticles is better than the tablet made of the raw material under the same conditions. High tensile strength.

[0051] Following the previous pre...

Example Embodiment

[0054] Example 3

[0055] 340g (85%) of aspirin, 53g (13.25%) of microcrystalline cellulose and 1g (0.25%) of magnesium stearate were mixed by high-shearing method according to the multiplying method, and placed in a tangential jet fluidized bed with fan frequency 30Hz, inlet air temperature 35℃, atomization pressure 0.05MPa, turntable speed 120rpm, spraying speed 3g / min, heating material to 30℃, and 2g / 100ml hydroxypropyl methylcellulose (viscosity 5cPs) aqueous solution (containing hydroxyl Propylmethyl cellulose 1.5%) is sprayed onto the heated dry mixture to form drug particles, which are heated and dried to obtain aspirin drug particles. The aspirin content is 85%, the particle size is 100-200μm, the angle of repose is 35°, the compression degree is 15%, and the fragility is 7%. The tensile strength of the tablet made of microparticles is higher than that of the tablet made of the raw material under the same conditions. high.

[0056] Following the previous preparation steps,...

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PUM

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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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