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Stable tegafur injection formula and preparation process thereof

A technology for tegafur and injection, which is applied in the field of stable tegafur injection formulation and preparation technology, can solve the problems of inconvenience to patients, decreased content of main drug, decreased pH value of finished products, etc., and achieves improved production capacity, increased safety Sexual protection, the effect of reducing the content of related substances

Inactive Publication Date: 2010-12-01
HARBIN PHARMA GROUP BIOLOGICAL ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the process of manufacturing and clinical application of tegafur injection, the pH value of the finished product decreases, the content of the main drug decreases, related substances increase, and crystallization occurs, which brings inconvenience to the use of patients.

Method used

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  • Stable tegafur injection formula and preparation process thereof
  • Stable tegafur injection formula and preparation process thereof
  • Stable tegafur injection formula and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Add 200g of tegafur into 1000ml of 1mol / L carbonate buffer solution, mix and stir for 10 minutes until completely dissolved, add 3500ml of water for injection, adjust the pH value to 9.6 with 1mol / L sodium hydroxide solution or 1M hydrochloric acid, Water for injection was added to make the volume to 5000ml, and the solution was sterilized and filtered with a 0.22 μm filter membrane until it became clear. After passing the test, it was filled into 1000 5ml ampoules to prepare the finished tegafur injection.

Embodiment 2

[0024] Add 200g of tegafur into 1000ml of 1mol / L carbonate buffer, heat to 40±2°C, mix and stir for 10 minutes until completely dissolved, add 3500ml of water for injection, and use 1mol / L sodium hydroxide solution or 1M Adjust the pH value to 10.0 with hydrochloric acid, add water for injection to make up to 5000ml, sterilize and filter the solution with a 0.22μm filter membrane until clear, fill it into 1000 5ml ampoules after passing the test, and prepare tegafur injection finished product.

Embodiment 3

[0026] Add 200g of tegafur into 1000ml of 1mol / L carbonate buffer, heat to 40±2°C, mix and stir for 10 minutes until completely dissolved, add 3500ml of water for injection, and use 1mol / L sodium hydroxide solution or 1M Adjust the pH value to 10.0 with hydrochloric acid, and add water for injection to make the volume to 5000ml. Add activated carbon to adsorb the solution, and filter it with a 0.45 μm filter membrane after 30 minutes until it becomes clear. Then the solution was sterilized and filtered with a 0.22 μm filter membrane until it became clear, and after passing the test, it was filled into 1000 5ml ampoules to obtain the finished product of tegafur injection.

[0027] Example 1-3 Stability investigation, investigation conditions: 25±2°C, 90 days

[0028]

[0029] Example 1-3 Stability investigation, investigation conditions: 25±2°C, 180 days

[0030]

[0031] Example 1-3 Stability investigation, investigation conditions: 25±2°C, 360 days

[0032]

[003...

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PUM

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Abstract

The invention researches a new preparation method aiming at the phenomena that the tegafur injection cannot realize scale production, has poor product stability and is easy to crystallize and the like so as to fulfill the purposes of producing the tegafur injection in scale, improving the product stability, removing crystals, reducing the content of related substance and the like. The pH value is adjusted by using carbonate and sodium hydroxide in a tegafur injection formula, the production speed is improved by heating in the preparation process, and the content of the related substances is reduced and the stability is improved by using active carbon.

Description

technical field [0001] The invention relates to a prescription of tegafur injection and a preparation process thereof, which are used by medical institutions for the treatment of tumor patients. Background technique [0002] Tegafur injection is one of the effective new pyrimidine anti-cancer drugs in recent years, and it has inhibitory effect on most solid tumors. It is a derivative of fluorouracil, which is gradually converted into fluorouracil in vivo through liver activation and plays an anti-tumor role. It can interfere and block the synthesis of DNA, RNA and protein, and mainly acts on the S phase. It is a cell cycle-specific drug against pyrimidines. It is mainly used to treat gastrointestinal tumors, such as gastric cancer, rectal cancer, pancreatic cancer, liver cancer, and can also be used for breast cancer. [0003] Compared with fluorouracil, tegafur injection has longer-lasting effect, better absorption and lower toxicity. The chemotherapy index is twice that...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/513A61K47/02A61P35/00
Inventor 赵华南王忠李会成冷国庆肖明辉陈玉军段志强李郑武张崇远高晶曹翊杰苏宏健黄炎
Owner HARBIN PHARMA GROUP BIOLOGICAL ENG
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