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Preparation method of tegafur gimeracil oteracil potassium capsule

A technology of capsules and preparations, applied in the field of medicine, can solve the problems of disintegrating agents that are easy to absorb moisture, not conducive to labor protection, and large dust, and achieve the effects of ensuring drug safety, benefiting labor protection, and rapid dissolution

Active Publication Date: 2013-06-12
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the disintegrating agent is easy to absorb moisture, it will lead to the degradation of the drug. At the same time, the micronization technology has a large dust, which is not conducive to labor protection.

Method used

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  • Preparation method of tegafur gimeracil oteracil potassium capsule
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  • Preparation method of tegafur gimeracil oteracil potassium capsule

Examples

Experimental program
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Effect test

Embodiment 1

[0023]

[0024]

[0025] Preparation Process:

[0026] Weigh the sucrose, add the prescribed amount of water, stir, and dissolve; weigh the prescribed amount of tegafur, gempyrimidine, and otirazide potassium, add to the sucrose aqueous solution, stir evenly, add to the ball mill, grind for 60 minutes, and grind the particle size measurement result , D90 <180nm. The suspension is spray-dried, and the spray-dried product and magnesium stearate are mixed uniformly, and then filled in a capsule filling machine to obtain it.

Embodiment 2

[0028]

[0029] Preparation Process:

[0030] Weigh the sucrose, add the prescribed amount of water, stir, and dissolve; weigh the prescribed amount of tegafur, gempyrimidine, and otirazide potassium, add to the sucrose aqueous solution, stir evenly, add to the ball mill, grind for 90 minutes, and grind the particle size measurement result , D90 <130nm. The suspension is spray-dried, and the spray-dried product and talc are evenly mixed, and then filled in a capsule filling machine to obtain it.

Embodiment 3

[0032]

[0033] Preparation Process:

[0034] Weigh the sucrose, add the prescribed amount of water, stir, and dissolve; weigh the prescribed amount of tegafur, gempyrimidine, and otirazide potassium, add to the sucrose aqueous solution, stir evenly, add to the ball mill, grind for 120 minutes, and grind the particle size measurement result , D90 <90nm. The suspension is spray-dried, and the spray-dried product is uniformly mixed with the micro-powdered silica gel, and then filled in a capsule filling machine to obtain it.

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Abstract

The invention provides a preparation method of a tegafur gimeracil oteracil potassium capsule. The preparation method comprises the following steps of: dispersing tegafur, gimeracil and potassium oxonate in a hydrophilic material aqueous solution; grinding by utilizing a ball mill; then spray-drying; evenly mixing the spray-dried material with a lubricant; and filling the mixture into a capsule.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a preparation method of a Tiggio capsule preparation. Background technique [0002] Tegafur (FT, FT207) is one of the pyrimidine anticancer drugs. It is a prodrug of 5-fluorouracil (5-FU) and has an inhibitory effect on most solid tumors. It can interfere with the biosynthesis of DNA, RHA and protein in the body, thereby producing its anti-cancer effect. Basic medical research and clinical observations have proved that tegafur has low side effects, high chemotherapy index, and has little effect on immunosuppression and related immune organs. It is a safe drug that can be used continuously in clinical practice. This product is absorbed through the gastrointestinal tract after oral administration, and the blood concentration reaches the highest peak within 1 to 3 hours. The duration is longer than intravenous administration, so it can exert its better therapeutic effect. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/53A61K31/513A61K31/44A61K9/48A61K47/26A61P35/00
Inventor 赵志全郝贵周陈美丽任英
Owner SHANDONG NEWTIME PHARMA
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