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Capecitabine solid preparation pharmaceutical composition and preparation method thereof

A capecitabine and solid preparation technology, applied in the field of capecitabine solid preparation pharmaceutical composition and its preparation, to achieve the effect of optimizing prescription quantity and stable product quality

Inactive Publication Date: 2013-12-25
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0034] The object of the present invention is to provide a kind of capecitabine solid preparation pharmaceutical composition and preparation method thereof, it can overcome the deficiencies in the prior art, effectively solve the problem of capecitabine solid preparation

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Prepare 1000 capecitabine solid preparation pharmaceutical compositions, the composition formula is as follows:

[0057]

[0058] When making:

[0059] 1) Raw and auxiliary materials pretreatment process: pass capecitabine, pregelatinized starch, and microcrystalline cellulose through a 60-mesh sieve respectively. 2) Granulation process: preparation of binder: prepare a 3% solution according to the ratio of povidone K30:purified water=3:97 (W:W). After sieving, capecitabine, pregelatinized starch, microcrystalline cellulose, and low-substituted hydroxypropyl cellulose sodium are added to a wet mixing granulator for premixing, and after premixing, a binder is added for granulation; The atomization pressure is 0.25-0.35Mpa, and when there are obvious particles in the soft material, the granulation is over. Wet granulate the prepared soft material on-line, the sieve aperture: 3×3mm. The fluidized bed is started and the wet granules are conveyed in-line to the fluidiz...

Embodiment 2

[0067] Simulate the large-scale production scale, with each batch of 30,000 pieces, scale up and produce 3 batches.

[0068] Sample trial batch number

[0069] It has been proved by experiments that the product prescription process is simple and feasible. More than three batches of products have been packaged in the accelerated test conditions of 40°C±2°C and relative humidity of 75%±5% for 6 months and long-term test conditions for 6 months. The results show that the quality is relatively stable and meets the production requirements.

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Abstract

The invention relates to the technical field of medicine dosage form structures, and particularly relates to a capecitabine solid preparation pharmaceutical composition and a preparation method thereof. The best formula and the optimal technology are selected through a great quantity of experiments and prescription screening to provide the capecitabine solid preparation pharmaceutical composition for the patients, thereby filling the domestic vacancy and meeting the clinical pharmaceutical needs.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical dosage forms, in particular to a capecitabine solid preparation pharmaceutical composition and a preparation method thereof. Background technique [0002] Breast cancer is one of the most common malignant tumors in women. According to statistics, the incidence rate accounts for 7-10% of all kinds of malignant tumors in the whole body. Its incidence is often related to genetics, and the incidence rate of women between the ages of 40 and 60 and before and after menopause is higher. Only about 1 to 2% of breast cancer patients are men. Malignant tumors usually occurring in the glandular epithelium of the breast. It is one of the most common malignant tumors that seriously affects women's physical and mental health and even threatens their lives. Male breast cancer is rare. [0003] Colorectal cancer is a common malignant tumor in the gastrointestinal tract. Early symptoms are not obvious. A...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/30A61K31/7068A61K47/38A61P35/00
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH