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Capecitabine pharmaceutical composition, and preparation method thereof

The technology of capecitabine and the composition is applied in the field of capecitabine pharmaceutical composition and preparation thereof, which can solve the problems of capecitabine being unstable when exposed to humidity, and achieve improved drug stability, fewer procedures, and simplified preparation. The effect of craftsmanship

Inactive Publication Date: 2014-06-04
SUZHOU XINBEIRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to provide a kind of capecitabine pharmaceutical composition and preparation method thereof that can be used for direct compression of powder, solve the problem that capecitabine encounters moisture Unstable problems, while strictly controlling the content of related substances to ensure the safety of medication

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

[0035] Preparation:

[0036] (1). Capecitabine 500mg, anhydrous lactose 10mg, microcrystalline cellulose 50mg, croscarmellose sodium 30mg, pulverize and sieve, mix well.

[0037] (2). 20 mg of micro-powdered silica gel is pulverized, sieved, and then fully mixed with the raw and auxiliary materials in step (1) and the powder is directly compressed into tablets.

[0038] (3). Take 25 mg of the film-coating composition, prepare a coating solution, and fluidize the plain tablet in (2), to obtain the final capecitabine film-coated tablet.

Embodiment 2

[0040] Preparation:

[0041] (1). Capecitabine 300mg, anhydrous lactose 5mg, microcrystalline cellulose 20mg, croscarmellose sodium 18mg, pulverize and sieve, mix well.

[0042] (2). 15 mg of micro-powdered silica gel is pulverized, sieved, and then fully mixed with the raw and auxiliary materials in step (1) and the powder is directly compressed into tablets.

[0043] (3). Take 18 mg of the film coating composition and prepare it into a coating solution, and fluidize the plain tablet in (2).

[0044] Obtain final capecitabine film-coated tablet.

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Abstract

The invention relates to a capecitabine pharmaceutical composition, and a preparation method thereof, and belongs to the technical field of medicine. The preparation method of the capecitabine pharmaceutical composition comprises following steps: a prescription dosage of capecitabine, a filler, a dry adhesive, and a disintegrating agent are mixed; an obtained mixture is smashed using an air-flow type pulverizer, and is sieved; an obtained material is mixed using a mixer, a lubricant is added, and an obtained mixed material is mixed uniformly using the mixer, and is subjected to tabletting so as to obtain capecitabine tablets; a coating solution is prepared from a thin membrane coating composition with gastric solubility, and is used for spraying; and obtained coated capecitabine tablets are dried slowly so as to obtain capecitabine thin membrane coated tablets. According to the preparation method, powder direct tabletting method is adopted to produce the capecitabine thin membrane coated tablets; technical processes are simple and few; medicine stability is high; effects are achieved quickly, fully and effectively; irritation of the capecitabine tablets on esophagus can be reduced via thin membrane coating; medicine stability is increased via thin membrane coating; and related substances in the capecitabine thin membrane coated tablets are controlled strictly so as to ensure quality and pharmacy safety of the capecitabine pharmaceutical composition.

Description

technical field [0001] The invention relates to a capecitabine pharmaceutical composition and a preparation method thereof. The dosage form has an active ingredient 5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine and belongs to the technical field of medicines. Background technique [0002] Cancer is one of the most serious diseases that threaten human life. With the aggravation of environmental pollution, the incidence of cancer continues to rise. At present, chemotherapy is the main means of treating cancer. Capecitabine (capecitabine) is a drug developed by Roche, Switzerland. An oral fluoropyrimidine carbamate anti-tumor prodrug is a new type of targeted drug, which was approved by the US FDA in 1998 and was registered and marketed in Japan with the same indication in April 2003. The chemical name of capecitabine is 5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine. [0003] The oral anticancer drug capecitabine has good clinical efficacy on metastatic breast cancer ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7068A61K9/28A61P35/00
Inventor 刘文婷杨毅
Owner SUZHOU XINBEIRUI PHARMA
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