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Sodium folinate injection and preparation method thereof

A technology of sodium folinate and injection, which is applied in the direction of pharmaceutical formulations, anti-toxins, drug combinations, etc., can solve problems such as poor stability, and achieve the effects of improving stability, saving costs, and simplifying formulations

Inactive Publication Date: 2006-07-12
凯基贸易有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because sodium folinate is sensitive to temperature, pH value, oxygen and other factors, and its stability is relatively poor, there is still a need to develop new sodium folinate injection products to meet clinical needs

Method used

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  • Sodium folinate injection and preparation method thereof

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Embodiment 1

[0020] Sterilize the mixing container with steam, then add 32.5-35.8L of water for injection into the sterilized mixing container at 20°C, keep the vacuum for 10 minutes, start nitrogen filling for at least 10 minutes, and keep nitrogen filling throughout the mixing process State: Add 2239g of folinic acid into the mixing container under stirring (150 rev / min), stir (150-200 rev / min) the suspension for 10 minutes, add 20% NaOH solution to completely dissolve the folinic acid into a salt, and simultaneously use 20% NaOH to adjust the pH value to 7.8-8.1, add and mix for 2 minutes each time to ensure a uniform solution, if necessary, add 3.7% hydrochloric acid to adjust the pH value to 7.8-8.1, add the remaining water for injection to reach the specified amount of 45.5kg , if necessary, add sodium chloride to adjust the osmotic pressure of the solution, continue to mix the solution for 9-12 minutes to ensure that the solution is uniform, use a sterilized pipette or flask to draw ...

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PUM

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Abstract

The invention relate to the sodium leucovorin injection and the preparing method. The sodium leucovorin injection contains sodium leucovorin and water for injection. The preparing method is to prepare sodium leucovorin solution through reaction with leucovorin and sodium-hydroxide solution, regulating the pH to 7.8-8.1 with sodium-hydroxide or chlorhydric acid to getting the half-finished product solution, filtering the half-finished product solution through double microporous filtering film (0.22ª–m), loading into bottle, sealing with rubber plug, the whole process is carried out in environment of filling with nitrogen. The property of the produced sodium leucovorin is stable, which is good for long term storage, there is little particle matter and chance for pollution, and the clinical effect is good.

Description

technical field [0001] The invention relates to a sodium folinate injection and a preparation method thereof. Background technique [0002] The chemical formula of folinic acid (FA) is N-[4-(2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-pteridine-6-methylamino)benzoyl ]-L(+)-glutamic acid, also known as 5-formyltetrahydrofolate or folinic acid. Calcium folinate has been on the market for many years at home and abroad. It is mainly used in combination with 5-fluorouracil in clinical practice to increase its effect in the treatment of colorectal cancer. It can also be used as a rescue drug for methotrexate overdose. Calcium folinate has certain limitations in clinical treatment due to the presence of calcium ions and poor solubility. The performance is as follows: (1) during clinical application, 1% calcium folinate solution needs to be dissolved in 0.9% sodium chloride isotonic solution, which increases the total amount of medication and the amount of ions irrelevant to tre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61K9/08A61P35/00A61P39/02
Inventor 周志强
Owner 凯基贸易有限公司
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