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Capecitabine pharmaceutical composition and preparation method thereof

A technology of capecitabine and its composition, applied in the field of pharmaceutical preparations, to achieve the effect of being beneficial to the treatment of gastric cancer, suitable for large-scale production, and reducing toxic and side effects

Active Publication Date: 2013-09-18
QILU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If capecitabine is released locally in the stomach, the toxic and side effects of the drug can be greatly reduced, but due to physiological factors such as gastric peristalsis and the influence of diet, the drug can only stay in the stomach for a short time

Method used

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  • Capecitabine pharmaceutical composition and preparation method thereof
  • Capecitabine pharmaceutical composition and preparation method thereof
  • Capecitabine pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] A capecitabine intragastric floating tablet, the main components of which are:

[0034] name

[0035] Preparation process: Pass capecitabine, hydroxypropyl methylcellulose, calcium carbonate, stearyl alcohol, and polyethylene glycol through 80 mesh sieves, mix evenly according to the above ratio, add an appropriate amount of purified water, and use pharmaceutical industry The known method is used for granulation, and the prepared granules are dried in a drying oven at 60° C. until the water content is 1%, and the granules are sized with a 30-mesh sieve. After mixing the prepared granules and magnesium stearate, press into tablets, the tablet hardness is controlled at 5kg / cm 2 , that is, this product.

Embodiment 2

[0037] A capecitabine intragastric floating tablet, the main components of which are:

[0038] name

[0039] Preparation process: Pass capecitabine, carbomer, magnesium carbonate, cetyl alcohol, and lactose through 80-mesh sieve respectively, mix evenly according to the above-mentioned ratio, add an appropriate amount of purified water, and granulate using a known method in the pharmaceutical industry. The prepared granules were dried in a drying oven at 60°C until the moisture content was 0.5%, and sieved with a 30-mesh sieve for sizing. After mixing the prepared granules and zinc stearate, press into tablets, the tablet hardness is controlled at 6kg / cm 2 , that is, this product.

Embodiment 3

[0041] A capecitabine intragastric floating tablet, the main components of which are:

[0042] name

[0043] Preparation process: Pass capecitabine, hydroxypropyl methylcellulose, sodium bicarbonate, stearyl alcohol, and polyvinylpyrrolidone through 80-mesh sieves, mix evenly according to the above ratio, add an appropriate amount of purified water, and use pharmaceutical industry The known method is used for granulation, and the prepared granules are dried in a drying oven at 60° C. until the water content is 0.3%, and the granules are sized with a 30-mesh sieve. After mixing the prepared granules and stearic acid, press into tablets, the tablet hardness is controlled at 4kg / cm 2 , that is, this product.

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Abstract

The invention relates to a capecitabine pharmaceutical composition for treating gasatric cancer, and a preparation method thereof. The pharmaceutical composition is prepared by taking capecitabine as bulk pharmaceutical chemicals and a foaming agent, a release modifier, a binding agent, a lubricant and the like as auxiliary ingredients through adopting pharmaceutical acceptable preparation technology including wet-process pelletizing or dry-process pelletizing and then tabletting. The capecitabine is prepared into gastric floating tablets which can target towards the stomach and can be kept in the stomach for longer time and slowly release pharmaceutics, the curative effect of the capecitabine on the gastric cancer can be enhanced, the peak valley change of blood concentration of pharmaceutics can be reduced, the toxic and side effects of the pharmaceutics can be reduced, and the effecting time of the pharmaceutics can be prolonged.

Description

technical field [0001] The invention relates to a pharmaceutical composition of capecitabine for treating gastric cancer and a preparation method thereof, in particular to a capecitabine intragastric floating tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Gastric cancer is a common malignant disease and one of the main causes of death worldwide. Due to the hidden onset of gastric cancer, less than 50% of gastric cancer patients are detected in the early stage. At present, most of the clinically diagnosed gastric cancer patients in China are In the advanced stage, surgical resection cannot be performed, and the treatment effect is not satisfactory. Domestic data report that the 5-year survival rate of advanced gastric cancer is only about 15%, and foreign data is only 5-40%. At this stage, intravenous infusion of 5-FU chemotherapy and systemic chemotherapy are mainly used for treatment, b...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/7068A61K47/44A61K47/38A61K47/36A61K47/34A61K47/32A61P35/00A61P1/00A61K47/10
Inventor 王晶翼郑晓清张明会杨清敏
Owner QILU PHARMA
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