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High-stability capecitabine tablets and preparation method thereof

A high-stability capecitabine technology, applied in the field of high-stability capecitabine tablets and its preparation, can solve the problems of poor drug stability, cumbersome preparation process, failure to provide stability, etc., and achieve The effect of rapid dissolution and simple preparation process

Inactive Publication Date: 2015-10-28
QINGDAO CENT HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process is cumbersome, and silicon dioxide is easy to absorb moisture, resulting in poor drug stability
[0014] Through careful retrieval and research of domestic and foreign literature, it is found that the prior art fails to provide a capecitabine tablet with good stability and rapid dissolution

Method used

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  • High-stability capecitabine tablets and preparation method thereof
  • High-stability capecitabine tablets and preparation method thereof
  • High-stability capecitabine tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037]

[0038]

[0039] Preparation Process:

[0040] (1) Add L-methionine to the purified water by weighing the prescription amount, stir until completely dissolved, and set aside;

[0041] (2) Capecitabine is pulverized and passed through an 80 mesh sieve, and the prescription amount is weighed to mix capecitabine, polycridine potassium, lactose, and copovidone, add L-methionine aqueous solution to granulate, pass through a 20 mesh sieve, Dry at 50°C, pass through a 20-mesh sieve for granulation, and dry the granules for later use;

[0042](3) Take the dry granules and mix them with sodium stearate fumarate evenly, punch the tablets with a Φ12mm inclined plane, and control the hardness to 80N-120N to obtain the product.

Embodiment 2

[0044]

[0045] Preparation Process:

[0046] (1) Add L-methionine to the purified water by weighing the prescription amount, stir until completely dissolved, and set aside;

[0047] (2) Pulverize capecitabine and pass through an 80-mesh sieve, weigh capecitabine, pocridine potassium, mannitol, and copovidone in the prescribed amount, mix evenly, add L-methionine aqueous solution to granulate, and pass through a 20-mesh sieve , dried at 50°C, passed through a 20-mesh sieve for granulation, and the dry granules are ready for use;

[0048] (3) Take the dry granules and mix them with magnesium stearate evenly, punch the tablets with a Φ12mm inclined plane, and control the hardness to 80N-120N to obtain the product.

Embodiment 3

[0050]

[0051]

[0052] Preparation Process:

[0053] (1) Add L-methionine to the purified water by weighing the prescription amount, stir until completely dissolved, and set aside;

[0054] (2) Pulverize capecitabine and pass through an 80-mesh sieve, weigh capecitabine, pocridine potassium, sorbitol, and copovidone in the prescribed amount, mix evenly, add L-methionine aqueous solution to granulate, and pass through a 20-mesh sieve , dried at 50°C, passed through a 20-mesh sieve for granulation, and the dry granules are ready for use;

[0055] (3) Take the dry granules and mix them evenly with calcium stearate, punch the tablets with a Φ12mm inclined plane, and control the hardness to 80N-120N.

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Abstract

The invention discloses high-stability capecitabine tablets and a preparation method thereof. The tablets contain L-methionine, polacrilin potassium and other auxiliary materials which are acceptable in pharmacy and low in hygroscopicity. The tables are prepared through the following steps: 1, weighing the L-methionine, and dissolving the L-methionine in the water for standby application; 2, smashing and sieving the capecitabine, weighing and mixing the capecitabine, the polacrilin potassium, filling agents and adhesion agents uniformly, adding an L-methionine aqueous solution for prilling, and conducting sieving, drying and granulating; 3, mixing dry particles and lubricating agents uniformly, and obtaining the capecitabine tablets through tabletting. The prepared tablets are small in related substance, good in stability, fast to dissolve, simple in preparation process and suitable for industrialized mass production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a high-stability capecitabine tablet and a preparation method thereof. Background technique [0002] Capecitabine (Capecitabine) is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate drug that can be converted into 5-FU in the body. It is developed by Roche and its trade name is Xeloda. It can inhibit cell division and interfere with RNA and protein synthesis, mainly used in the treatment of advanced primary or metastatic breast cancer, rectal cancer, colon cancer and gastric cancer. [0003] The chemical name of capecitabine is 5'-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine, molecular formula C 15 h 22 o 6 N 3 F, molecular weight 359.35, structural formula as follows: [0004] [0005] The compound has poor stability, and the amide bond is prone to hydrolysis under high temperature and high humidity conditions to generate imp...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/7068A61K47/18A61K47/32A61P35/00A61P35/04
Inventor 孙丽华
Owner QINGDAO CENT HOSPITAL
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