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Preparation method of stable tegafur injection liquid

A technology of tegafur and injection, which is applied in the field of medicine, can solve the problems of solution color turning yellow, unqualified foreign matter inspection, pH value drop, etc., and achieve the effect of being convenient for clinical medication and popularization

Active Publication Date: 2014-08-20
SICHUAN SUNNYHOPE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Through creative work, it was found that the tegafur injection is more stable, and the content of the related substance fluorouracil is greatly reduced compared with the existing technology, which solves the problem that the pH value of the tegafur injection drops during high-temperature sterilization and storage in the prior art products , the solution color turns yellow, the inspection of visible foreign matter is unqualified, and the inspection of related substances is unqualified

Method used

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  • Preparation method of stable tegafur injection liquid
  • Preparation method of stable tegafur injection liquid
  • Preparation method of stable tegafur injection liquid

Examples

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Comparison scheme
Effect test

Embodiment 1

[0028] A stable tegafur injection and a preparation method thereof, comprising the following steps: (1) weighing 1 g to 100 g of tegafur, 10 mg to 50 g of an antioxidant, and 10 mg to 50 g of a pH buffer; (2) taking an acid solution and / or sodium hydroxide are prepared into solutions of any concentration respectively, for subsequent use; (3) take 500ml of water for injection below 40°C, add antioxidant, pH value buffer, tegafur in sequence, stir, and use step (2) The prepared acid solution and / or sodium hydroxide solution is adjusted to a pH value of 10.5 to 12.0, and the water for injection below 40°C is supplemented to 1000ml; (4) the solution obtained in step (3) is added with activated carbon, and the amount of activated carbon is 0.005g to 1000ml; 0.5g / 100ml, stirred for 10-60 minutes, decarburized by filtration; (5) finely filtered the injection solution obtained in step (4) until clarified, filled with nitrogen for protection, filled, and sterilized at high temperature t...

Embodiment 2

[0033] The specific components and contents thereof of the present embodiment are as follows:

[0034]

[0035] Citric acid and / or sodium hydroxide are formulated into 10% to 20% solutions respectively for later use; take 500ml of water for injection below 40°C, add L-cysteine, sodium citrate, and tegafur in sequence, stir, Use the citric acid solution and / or sodium hydroxide solution prepared above to adjust the pH value to 10.5-12.0, make up water for injection below 40°C to 1000ml; add activated carbon to the obtained solution, the amount of activated carbon is 0.1g / 100ml, stir for 30 Minutes, decarburized by filtration; the resulting injection was fine-filtered until clarified, filled with nitrogen for protection, filled, and autoclaved at 115°C for 30 minutes to obtain the product.

Embodiment 3

[0037] The specific components and contents thereof of the present embodiment are as follows:

[0038]

[0039]Hydrochloric acid and / or sodium hydroxide were formulated into 10%-20% solutions respectively for later use; take 500ml of water for injection below 40°C, add L-cysteine, sodium carbonate, and tegafur in sequence, stir, and use the above Adjust the pH of the prepared hydrochloric acid solution and / or sodium hydroxide solution to 10.5-12.0, make up water for injection below 40°C to 1000ml; add activated carbon to the obtained solution, the amount of activated carbon is 0.1g / 100ml, stir for 30 minutes, and filter Decarburization; the resulting injection is finely filtered until clarified, filled with nitrogen for protection, filled, and sterilized by autoclaving at 100°C for 30 minutes.

[0040] When the present invention is implemented, the antioxidant can be one of L-cysteine, sodium sulfite, amino acid and VC palmitate, and its consumption is any value in 1mg~10g / ...

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Abstract

The invention discloses a stable tegafur Injection liquid and a preparation method thereof. The stable tegafur Injection liquid is mainly prepared from tegafur and injection water by using a sodium hydroxide solution and / or an acid solution to adjust the injection liquid pH value to be 11.1-12.0, adding an antioxidant and a pH value buffer, charging nitrogen for protection, and then sterilizing at high temperature. The preparation method can make the tegafur Injection liquid more stable, high temperature sterilization can be performed, compared with the prior art, related substances are greatly reduced, especially the problems that pH value is decreasing, the solution color changes into yellow, the visible foreign matter testing is unqualified and the related substance testing is unqualified in high temperature sterilization and storage processes of a tegafur Injection liquid prepared from products in the prior art can be solved, and the method can ensure the product meets the requirement of drug quality standards and facilitates clinical medicine use and promotion.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a stable tegafur injection and a preparation method thereof. Background technique [0002] Tegafur is a derivative of fluorouracil, which is converted into fluorouracil by liver activation in vivo to exert its anti-tumor activity. It is mainly used clinically to treat gastrointestinal tumors, such as gastric cancer, rectal cancer, pancreatic cancer, and liver cancer. It can also be used for breast cancer. At present, the dosage forms of domestic marketed preparations mainly include injection and oral preparations. The bioavailability of oral preparations of this product is worse than that of injections, and Tegafur injections are more clinically used. [0003] In the quality standard for tegafur injection contained in the 2010 edition of the Chinese Pharmacopoeia, the pH value range of the injection is specified to be 9.5 to 10.5, and the detection methods for relate...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/513A61K47/18A61K47/22A61K47/04A61K47/26A61P35/00
Inventor 毛长兴陈开军曹原湘向先旭程亮胥勤黄筱萍
Owner SICHUAN SUNNYHOPE PHARM CO LTD
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