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Method for preparing sodium fructose diphosphate injection

A technology of sodium fructose diphosphate and injection, which is applied in the field of medicine, can solve problems affecting product purity and product osmotic pressure, and achieve the effect of reducing irritation and local pain and simple process

Inactive Publication Date: 2008-08-20
广东宏远集团药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The key to the process route of this product is the choice of reagents or methods for lowering the pH value. The common method for lowering the pH value is to add a certain amount of acid, but the corresponding impurities must be introduced, which affects the purity of the product and the osmotic pressure of the product.

Method used

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  • Method for preparing sodium fructose diphosphate injection
  • Method for preparing sodium fructose diphosphate injection
  • Method for preparing sodium fructose diphosphate injection

Examples

Experimental program
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Effect test

example I

[0043] Example 1: prescription composition: in 1000 bottles

[0044] Sodium fructose diphosphate 5kg (dried and pure)

[0045] Sodium bisulfite 1 / 10000(W / V)

[0046] 50% NaOH solution to adjust the pH value to 3.9-4.2

[0047] Add water for injection to 50,000ml

[0048] Preparation process: Sodium fructose diphosphate is dissolved in water for injection, and the liquid passes through 732 # Reduce the pH value of the cation exchange resin to below 3.9, add water for injection to the volume of the prescription, stir evenly, and then adjust it to 3.9-4.2 with sodium hydroxide solution, add sodium bisulfite, add activated carbon for adsorption, decarbonize, sterilize and filter, and the medicine After checking the liquid content, pH value and visible foreign matters, it is dispensed into sterile bottles, and the caps are capped after stoppering.

example II

[0049] Example II: Prescription: based on 1000 bottles

[0050] Sodium fructose diphosphate 10kg (dried and pure)

[0051] Sodium bisulfite 1 / 10000(W / V)

[0052] 50% NaOH solution to adjust the pH value to 3.9-4.2

[0053] Add water for injection to 100,000ml

[0054] Preparation process: Sodium fructose diphosphate is dissolved in water for injection, and the liquid passes through 732 # Reduce the pH value of the cation exchange resin to below 3.9, add water for injection to the volume of the prescription, stir evenly, and then adjust it to 3.9-4.2 with sodium hydroxide solution, add sodium bisulfite, add activated carbon for adsorption, decarbonize, sterilize and filter, and the medicine After checking the liquid content, pH value and visible foreign matters, it is dispensed into sterile bottles, and the caps are capped after stoppering.

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Abstract

The invention relates to a preparation method of fructose sodium diphosphate injection, belonging to the technical field of medicine. The preparation method is: medical solution is treated by cation exchange resin, which can reduce acidity, remove metal cation, absorb colorful impurities and pyrogens, increase the clarity of the medical solution, avoid the defects of decreasing the product purity, increase osmotic pressure, and influencing medication safety caused by acid radical ion when acid is used to regulate acidity, and provides a stable fructose sodium diphosphate injection with high purity. The fructose sodium diphosphate injection is applied to intravenous injection or intravenous drip in clinical practice, and is suitable for low phosphorus acidemia. The preparation method has the advantages: the preparation method is simple and controllable, and the prepared product quality is stable and safe for clinical use.

Description

(1) Technical field [0001] The invention relates to a preparation method of sodium fructose diphosphate injection, belonging to the field of medicine. (2) Background technology [0002] Sodium fructose diphosphate injection is a marketed product with relatively large clinical use. Clinically used for hypophosphatemia. Hypophosphatemia can occur in acute situations such as blood transfusions, surgery under extracorporeal circulation, parenteral nutrition, and is also associated with some chronic diseases such as chronic alcoholism, chronic malnutrition, and depletion of carbonic acid in chronic respiratory failure. The pH value needs to be adjusted in the preparation process of sodium fructose diphosphate injection. When the pH value is adjusted with commonly used acids, the corresponding acid radical ions are brought in, which affects the purity of the drug, increases the osmotic pressure of the drug solution, and enhances the patient’s safety during clinical medication. I...

Claims

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Application Information

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IPC IPC(8): A61K31/70A61K9/08A61P7/00
Inventor 罗四通蒋琼郭德铭罗广生陈波成土生
Owner 广东宏远集团药业有限公司
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