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A kind of fluorouracil for injection and preparation method thereof

A technology for fluorouracil and injection, which is applied in the field of fluorouracil for injection and its preparation. It can solve the problems of poor stability of freeze-dried powder, difficulty in obtaining freeze-dried powder injection, unfavorable safe drug administration, etc., and achieve good dissolution rate and good appearance. Effect

Active Publication Date: 2020-08-11
德州志道医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the vesicle dosage form of fluorouracil has been developed. However, when the vesicles are prepared into freeze-dried powder, due to the special structure of the vesicles, it is difficult to obtain a freeze-dried powder injection that meets the requirements, and the obtained freeze-dried powder has poor stability. , is not conducive to the safe administration of clinical

Method used

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  • A kind of fluorouracil for injection and preparation method thereof
  • A kind of fluorouracil for injection and preparation method thereof
  • A kind of fluorouracil for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0035] (1) get cholesterol hemisuccinate and Span 80 according to mass ratio 1: 2.5 and be dissolved in the mixed solvent of dichloromethane and ethanol, the volume ratio of dichloromethane and ethanol is 1: 3, and the volume ratio of dichloromethane and ethanol is 1: 3. The total mass of the mixed solvent is 23 times the total mass of cholesterol hemisuccinate and Span 80, to obtain the first mixed solution, the mixed solution is placed in a round-bottomed container, and the solvent is rotated and evaporated to dryness to form a film;

[0036] (2) get poloxamer and sodium chloride to be dissolved in the mixed solvent of ethanol and water according to mass ratio 1: 1.5, the mass ratio of ethanol and water is 1: 2, and the total mass of the mixed solvent of ethanol and water is po 9 times of the total mass of loxamer and sodium chloride, obtain the third mixed solution, the third mixed solution is added in the round-bottomed container of step (1), and the solvent is rotary evapo...

Embodiment 2

[0043] (1) get cholesterol hemisuccinate and Span 80 according to mass ratio 1:2 and be dissolved in the mixed solvent of dichloromethane and ethanol, the volume ratio of dichloromethane and ethanol is 1:3, and the volume ratio of dichloromethane and ethanol is 1:3. The total mass of the mixed solvent is 23 times the total mass of cholesterol hemisuccinate and Span 80, to obtain the first mixed solution, the mixed solution is placed in a round-bottomed container, and the solvent is rotated and evaporated to dryness to form a film;

[0044] (2) get poloxamer and sodium chloride and be dissolved in the mixed solvent of ethanol and water according to mass ratio 1: 1.7, the mass ratio of ethanol and water is 1: 3, and the total mass of the mixed solvent of ethanol and water is po 8 times of the total mass of loxamer and sodium chloride, obtain the third mixed solution, the third mixed solution is added in the round-bottomed container of step (1), and the solvent is rotary evaporate...

Embodiment 3

[0051] (1) get cholesterol hemisuccinate and Span 80 according to mass ratio 1:2 and be dissolved in the mixed solvent of dichloromethane and ethanol, the volume ratio of dichloromethane and ethanol is 1:3, and the volume ratio of dichloromethane and ethanol is 1:3. The total mass of the mixed solvent is 24 times the total mass of cholesterol hemisuccinate and Span 80 to obtain the first mixed solution, the mixed solution is placed in a round-bottomed container, and the solvent is rotated to dryness to form a film;

[0052] (2) get poloxamer and sodium chloride to be dissolved in the mixed solvent of ethanol and water according to mass ratio 1:1.8, the mass ratio of ethanol and water is 1:2, and the total mass of the mixed solvent of ethanol and water is po 9 times of the total mass of loxamer and sodium chloride, obtain the third mixed solution, the third mixed solution is added in the round-bottomed container of step (1), and the solvent is rotary evaporated to dryness to for...

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Abstract

The invention discloses fluorouracil for injection and a preparation method of fluorouracil for injection. The preparation method includes steps: dissolving cholesteryl hemisuccinate and span 80 intodichloromethane and ethanol mixed solvent to obtain first mixed solution, adding the mixed solution into a round-bottomed container, and performing solvent rotary evaporation to form a film; dissolving poloxamer and sodium chloride into ethanol and water mixed solvent to obtain third mixed solution, adding the third mixed solution into the round-bottomed container, and performing solvent rotary evaporation to form a film; taking deionized water, adopting NaOH to adjust pH to 7.8-8 to obtain alkali solution, dissolving 5-fluorouracil and tween 20 into the alkali solution to obtain second mixedsolution, adding the second mixed solution into the round-bottomed container, and ultrasonically treating at 40-50 DEG C for 30-40min to obtain vesicle solution; subjecting the vesicle solution to subpackaging and freeze drying to obtain fluorouracil for injection.

Description

technical field [0001] The application relates to a fluorouracil for injection and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Fluorouracil, also known as 5-fluorouracil (5-Fu), is a pyrimidine antimetabolite and is a commonly used chemotherapeutic drug in clinical practice. Inhibits DNA biosynthesis, thereby inhibiting the growth of cancer cells. Clinically used for the treatment of gastrointestinal tumors, such as gastric cancer, intestinal cancer, liver cancer, etc. It is also effective for breast cancer, ovarian cancer, lung cancer, bladder cancer, cervical cancer, pancreatic cancer, etc. [0003] Fluorouracil is first converted into 5-fluoro-2-deoxyuracil nucleotides in the body, which inhibits thymidine nucleotide synthase and blocks the conversion of uracil deoxynucleotides into thymidine deoxynucleotides, thereby affecting DNA biosynthesis. At the same time, it can be incorporated into RNA to directly inhibit RN...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K9/127A61K31/513A61K47/10A61K47/28A61P35/00
CPCA61K9/0019A61K9/1273A61K9/19A61K31/513A61K47/10A61K47/28A61P35/00
Inventor 蔡春梅蔡玉梅姚荷云陈国华韩强李洪水王雁飞
Owner 德州志道医药科技有限公司
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