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Solid dispersion containing anti-breast cancer drug tamoxifen, preparation method and preparation

A technology of solid dispersion and tamoxifen, which is applied in the direction of medical preparations containing active ingredients, drug combinations, antineoplastic drugs, etc., can solve poor solubility, easy aging of solid dispersion, and poor water solubility of tamoxifen And other issues

Active Publication Date: 2022-07-22
THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The prior art has solved the problem of low dissolution rate caused by the poor solubility of tamoxifen through solid dispersion technology, but the problem that the solid dispersion is prone to aging phenomenon has not been properly solved, such as low dissolution rate and slow dissolution rate after long-term storage. Problems such as complete and related substance content can rise, the present invention overcomes the deficiencies in the prior art, solves the above-mentioned problems, provides a kind of stable tamoxifen solid dispersion and preparation
[0009] First, in order to solve the problem of poor water solubility of tamoxifen, the present invention utilizes solid dispersion technology, utilizes the encapsulation of carrier as, exists with highly dispersed state with medicine in the carrier, increases the stripping rate of medicine

Method used

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  • Solid dispersion containing anti-breast cancer drug tamoxifen, preparation method and preparation
  • Solid dispersion containing anti-breast cancer drug tamoxifen, preparation method and preparation
  • Solid dispersion containing anti-breast cancer drug tamoxifen, preparation method and preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The preparation of embodiment 1 tamoxifen solid dispersion

[0024]

[0025] Preparation:

[0026] Dissolve tamoxifen, sugar alcohol-based hydrophilic carrier, and surfactant-based hydrophilic carrier in an appropriate amount of ethanol, heat and rotate in a water bath at 25°C-40°C for 2-4h, and change from 25°C-40°C according to the speed of the distillate. The temperature is gradually adjusted at ℃, and the organic solvent is evaporated to obtain a coprecipitate, which is washed and dried to obtain a solid dispersion of tamoxifen with a drug loading of 14.7±0.3%.

Embodiment 2

[0027] Example 2 Tamoxifen Tablets (100 Tablets)

[0028]

[0029]

[0030] Preparation:

[0031] According to the formula, the tamoxifen solid dispersion, filler, disintegrant and glidant prepared in Example 1 were respectively crushed, sieved, mixed uniformly, and pressed into tablets.

Embodiment 3

[0032] Example 3 Preparation of Tamoxifen Solid Dispersion

[0033]

[0034] Preparation:

[0035] Dissolve tamoxifen, sugar alcohol-based hydrophilic carrier, and surfactant-based hydrophilic carrier in an appropriate amount of ethanol, heat and rotate in a water bath at 25°C for 10-30min, slowly add an appropriate amount of ethanol-dissolved organic acid solution, and continue at 25°C -40℃ water bath heating and rotary steaming for 2-4h, gradually adjust the temperature from 25℃-40℃ according to the speed of the distillate, evaporate the organic solvent to obtain a coprecipitate, wash and dry to obtain the solid dispersion of tamoxifen, The drug loading was 15.9±0.2%.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a tamoxifen solid dispersion, a preparation method and a preparation thereof, and the tamoxifen-containing solid dispersion comprises tamoxifen, a sugar alcohol hydrophilic carrier, a surfactant hydrophilic carrier and a proper amount of organic acid. According to the tamoxifen solid dispersion, the problem of low dissolution rate caused by poor solubility of tamoxifen is solved through a solid dispersion technology, the problem that the solid dispersion is easy to age is also solved, and the stability of the solid dispersion and the preparation is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a solid dispersion containing an anti-breast cancer drug tamoxifen, a preparation method and a preparation. Background technique [0002] Breast cancer is a phenomenon in which mammary epithelial cells proliferate out of control under the action of various carcinogenic factors. In the early stage of the disease, symptoms such as breast lumps, nipple discharge, and enlarged axillary lymph nodes are often present. In the late stage, cancer cells may metastasize far away, resulting in multi-organ lesions, which directly threaten the patient's life. Clinical treatment in recent years has found that the average ten-year survival rate of breast cancer is 60%, the survival rate after the first stage breast cancer treatment is 80%, and the survival rate after zero stage breast cancer treatment is closer to 100%. Treatment is very important. [0003] Tamo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/138A61K47/10A61K47/12A61P35/00
CPCA61K31/138A61K9/145A61K47/10A61K47/12A61P35/00
Inventor 余朴崔扛
Owner THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIV
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