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Method for preparing tegafur, gimeracil and oteracil potassium capsules

A capsule preparation and capsule technology, which is applied in the field of medicine, can solve the problems that are not conducive to labor protection, the disintegrating agent is easy to absorb moisture, and the dust is large, so as to achieve the effects of being beneficial to labor protection, improving drug dissolution, and avoiding aggregation

Active Publication Date: 2013-07-24
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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  • Method for preparing tegafur, gimeracil and oteracil potassium capsules
  • Method for preparing tegafur, gimeracil and oteracil potassium capsules
  • Method for preparing tegafur, gimeracil and oteracil potassium capsules

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030]

[0031] Preparation Process:

[0032] (1) Tegafur was dissolved in methanol, gimeracil was dissolved in hydrochloric acid solution, oteracil potassium was dissolved in sodium hydroxide solution;

[0033] (2) After mixing the three solutions quickly, quickly add microcrystalline cellulose and stir to obtain nanoscale drugs attached to the microcrystalline cellulose;

[0034] (3) Dry the drug-containing granules at 60°C, and sieve the granules with 20 meshes;

[0035] (4) Add magnesium stearate to the dry granules, mix well, and pack into capsules.

Embodiment 2

[0037]

[0038]

[0039] Preparation Process:

[0040] (1) Tegafur was dissolved in methanol, gimeracil was dissolved in hydrochloric acid solution, oteracil potassium was dissolved in sodium hydroxide solution;

[0041] (2) After mixing the three solutions quickly, quickly add microcrystalline cellulose and stir to obtain nanoscale drugs attached to the microcrystalline cellulose;

[0042] (3) Dry the drug-containing granules at 60°C, and sieve the granules with 20 meshes;

[0043] (4) Add micropowder silica gel to dry granules, mix well, and put into capsules.

Embodiment 3

[0045]

[0046] Preparation Process:

[0047] (1) Tegafur was dissolved in methanol, gimeracil was dissolved in hydrochloric acid solution, oteracil potassium was dissolved in sodium hydroxide solution;

[0048] (2) After mixing the three solutions quickly, quickly add microcrystalline cellulose and stir to obtain nanoscale drugs attached to the microcrystalline cellulose;

[0049] (3) Dry the drug-containing granules at 60°C, and sieve the granules with 20 meshes;

[0050] (4) Add magnesium stearate to the dry granules, mix well, and pack into capsules.

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PUM

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Abstract

The invention relates to a method for preparing tegafur, gimeracil and oteracil potassium capsules. The method comprises the steps of dissolving tegafur in methanol, dissolving gimeracil in a hydrochloric acid solution, dissolving oteracil potassium in a sodium hydroxide solution, rapidly mixing the three solutions, rapidly adding microcrystalline cellulose and stirring, slowly cooling to about 4 DEG C at the same time to obtain nanoscale drug adhered to the microcrystalline cellulose, drying drug-containing particles, adding a lubricant into the dry particles, uniformly mixing and encapsulating. According to the invention, the technologies of acid-base neutralization and nanometer crystallization are creatively utilized to prepare nanoscale tegafur, gimeracil and oteracil potassium, so that the drug dissolution rate is greatly increased.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preparation method of tigio capsules. Background technique [0002] Tegafur (FT, FT207) is one of the pyrimidine anticancer drugs. It is the prodrug of 5-fluorouracil (5-FU), and has inhibitory effect on most solid tumors. In the body, it can interfere and block the biosynthesis of DNA, RHA and protein, thereby producing its anticancer effect. Basic medical research and clinical observation have proved that tegafur has less toxic and side effects, higher chemotherapy index, less effect on immunosuppression and related immune organs, and 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 that of intravenous administration, so it can exert its better therapeutic ...

Claims

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Application Information

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IPC IPC(8): A61K31/53A61K9/48A61P35/00A61K31/513A61K31/44
Inventor 赵志全郝贵周刘阿利吴善霞陈美丽
Owner SHANDONG NEWTIME PHARMA
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