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Phosphate binder and preparation method thereof

A phosphorus binder and mixed solution technology, which is applied in the direction of drug combination, pharmaceutical formula, carbohydrate active ingredients, etc., can solve the problems of side effects of patients, low phosphorus adsorption capacity, etc.

Inactive Publication Date: 2017-11-28
CINKATE PHARMA INTERMEDIATES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because the patient's daily diet contains a large amount of phosphorus, and the phosphorus adsorption capacity of the existing phosphorus binders is too low, in order to control the blood phosphorus concentration to a normal level, the patient needs to use a large amount of phosphate binders every day, and overdose other side effects for patients

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  • Phosphate binder and preparation method thereof

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preparation example Construction

[0053] The invention provides a preparation method of a phosphorus binding agent, mixing iron salts, carbohydrates, citric acid or citrates such as (sodium citrate) or carbonates in a certain proportion to obtain the described phosphorus binding agent agent.

[0054] A preferred preparation method is as follows:

[0055] (i) providing a mixture comprising (a) carbohydrates, (b) citric acid, citrates, carbonates, or combinations thereof; and (c) water;

[0056] (ii) under alkaline conditions, adding iron salt to the mixed solution to generate a precipitate, and separating the precipitate to obtain the phosphorus binder; wherein, the pH under the alkaline condition is 4-13.

[0057] Another preferred preparation method is as follows:

[0058] Ⅰ Dissolution: Dissolve carbohydrates and weak base in distilled water, stir well, and control the temperature of the solution from room temperature to 100°C, preferably between 40°C and 100°C, more preferably between 70°C and 90°C. Weak b...

Embodiment 1

[0092] 1. Dissolve 10g of gum arabic and 2.5g of sodium citrate in 50mL of distilled water at a temperature of 90°C and stir until fully dissolved;

[0093] 2 Add 20% ferric chloride aqueous solution dropwise to the solution at a temperature of 90°C, and simultaneously add 20% NaOH aqueous solution dropwise to control the pH of the reaction solution to be 7.5-8.5 until there is obvious precipitation, stop the dropwise addition, and Stir at ℃ for 2h to obtain a reddish-brown solution;

[0094] 3 After cooling to room temperature, centrifuge to remove the solids in the solution, add 2 times the volume of 95% ethanol, centrifuge after the precipitation is complete, and wash twice with 70% ethanol to fully wash out the salt in the product;

[0095] 4 The product obtained in steps 1-3 was isolated by spray drying.

[0096] The performance of the obtained product was detected by the phosphoric acid absorbing capacity test method of the present invention.

[0097] The results are s...

Embodiment 2

[0101] 1 Dissolve 100g of gum arabic, 10g of sodium citrate and 10g of sodium carbonate in 500mL of distilled water at a temperature of 90°C and stir to fully dissolve;

[0102] 2 Add 20% ferric chloride aqueous solution dropwise to the solution at a temperature of 90°C, and simultaneously add 20% NaOH aqueous solution dropwise to control the pH of the reaction solution to be 8.0-9.0 until there is obvious precipitation, stop the dropwise addition, and Stir at ℃ for 2h to obtain a reddish-brown solution;

[0103] 3 After cooling to room temperature, centrifuge to remove the solids in the solution, add 2 times the volume of 95% ethanol, centrifuge after the precipitation is complete, and wash twice with 70% ethanol to fully wash out the salt in the product;

[0104] 4 The product obtained in steps 1-3 was isolated by spray drying.

[0105] The performance of the obtained product was detected by the phosphoric acid absorbing capacity test method of the present invention.

[01...

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Abstract

The invention provides a phosphate binder and a preparation method thereof and in particular provides a method for preparing the phosphate binder. The method comprises the following steps: (i) providing a mixed solution, wherein the mixed solution comprises (a) a carbohydrate; (b) citric acid, citrate, carbonate or a combination thereof, and (c) water; and (ii) adding an iron salt and an insoluble solvent into the mixed solution under alkaline conditions, producing a precipitate, and separating the precipitate, thereby obtaining the phosphate binder, wherein the pH value of the alkaline condition is 4-13. According to the method disclosed by the invention, the phosphate binder is capable of obviously reducing the serum phosphate concentration.

Description

technical field [0001] The invention relates to a phosphorus binder, in particular to a phosphorus binder and a preparation method thereof. Background technique [0002] Hyperphosphatemia is one of the main complications of chronic renal insufficiency (CKD). Increased blood phosphorus concentration is closely related to the mortality of CKD patients, and increased blood phosphorus concentration will lead to further decline of renal function and secondary thyroid function resistance. , vascular calcification and minerals, bone metabolism disorders. It is generally believed that regulating phosphorus metabolism is the key to reducing cardiovascular complications, improving the quality of life of dialysis patients, and reducing morbidity and mortality. [0003] In recent years, new phosphorus binders have been developed continuously. Among them, the iron-containing phosphorus binder has been proved to be a high-efficiency phosphorus binder, and will not cause ectopic calcific...

Claims

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Application Information

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IPC IPC(8): A61K33/26A61P3/12A61P37/04A61P5/16A61P3/14A61P13/12A61P19/08A61P9/00A61K31/70A61K31/191
CPCA61K31/191A61K31/70A61K33/26A61K2300/00
Inventor 梁星崔洋洋许婧陆佳美包丽霞刘荣军袁西伦肖飞
Owner CINKATE PHARMA INTERMEDIATES
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