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Aftertreatment method for Bixalomer

A bisalom and purified water technology, applied in the field of medicine, can solve the problems of high swelling rate, high chlorine content, and low phosphate binding amount, and achieve the effect of low swelling rate, low chlorine content, and simple operation

Inactive Publication Date: 2019-01-18
SHANDONG CHENGCHUANG PHARMA R&D
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The chlorine content of method one gained product is high, swelling rate is high, phosphate binding capacity is low, and method two can obtain solid product, and this product swelling rate (when being balanced in aqueous environment, per gram of dry cross-linked polymer absorbed solvent The number of grams) is low, about less than 2.5, but the phosphate binding amount of the product is lower than that of Bisalom Japan’s listing preparation (trade name: キックリン カプセル 250mg, Astellas Pharma Inc.), and the chlorine content of the resulting product is relatively high, which has a more serious amplification effect

Method used

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  • Aftertreatment method for Bixalomer
  • Aftertreatment method for Bixalomer
  • Aftertreatment method for Bixalomer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Dissolve 15g (47.4mmol) of N,N,N',N'-tetra(3-aminopropyl)-1,4-butanediamine in 15g of purified water, lower the temperature to 15-20°C, and add epoxy chlorine dropwise Propane 9.21g (99.5mmol), temperature control does not exceed 25°C, heat up to 80°C after dropwise addition, react for 9 hours, then cool down to room temperature, add the reaction residue into 300mL of purified water, stir, pulverize, and wash with anhydrous methanol , 1wt% dilute hydrochloric acid, 5wt% sodium hydroxide aqueous solution, purified water, washed with 300mL of purified water, and dried under normal pressure at 50°C for 24 hours to obtain 15g of product with a yield of 61.9%.

Embodiment 2

[0048] Dissolve 150g (0.474mol) of N,N,N',N'-tetrakis(3-aminopropyl)-1,4-butanediamine in 150g of purified water, lower the temperature to 15-20°C, and add epoxy chloride dropwise Propane 96.46g (1.04mol), temperature control does not exceed 25°C, heat up to 80°C after dropwise addition, react for 10 hours, then cool down to room temperature, add the reaction residue into 3000mL of purified water, stir, pulverize, and wash with anhydrous methanol , 1wt% dilute hydrochloric acid, 5wt% sodium hydroxide aqueous solution, purified water, washed with 3000mL of purified water, and dried under normal pressure at 50°C for 35 hours to obtain 155g of product with a yield of 62.9%.

Embodiment 3

[0050] Dissolve 1.5kg (4.74mol) of N,N,N',N'-tetrakis(3-aminopropyl)-1,4-butanediamine in 1.5kg of purified water, cool down to 15-20°C, add ring Oxychloropropane 1.01kg (10.9mol), temperature control not exceeding 25°C, heat up to 80°C after dropwise addition, react for 9 hours, cool down to room temperature, add the reaction residue into 30L of purified water, stir, pulverize, and use Water methanol, 1wt% dilute hydrochloric acid, 5wt% sodium hydroxide aqueous solution, purified water, washed with 30L of purified water, and dried at 50°C under normal pressure for 48 hours to obtain 1.57kg of product with a yield of 62.5%.

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Abstract

The invention discloses an aftertreatment method for Bixalomer. The method is simple to operate, a product has low chlorine content and low swelling rate, and the phosphate binding amount is equivalent to that of Japanese listed preparations. The method comprises the following specific steps: after the reaction is completed, reaction residues are added to purified water, and the mixture is stirred, crushed, washed and dried, wherein in the washing step, anhydrous methanol, dilute hydrochloric acid, sodium hydroxide solution and purified water are used for washing.

Description

technical field [0001] The invention relates to a post-treatment method, in particular to a bisalom post-treatment method. It belongs to the field of medical technology. Background technique [0002] The incidence rate of chronic kidney disease is as high as 10%, and it has become an invisible killer threatening human health. Hyperphosphatemia is a common complication in patients with chronic kidney disease, especially end-stage renal disease, and can be found in 80% of dialysis patients. Hyperphosphatemia is an important factor in ectopic calcification, secondary hyperparathyroidism, and renal osteodystrophy. Effective control of serum phosphorus levels is key to the prognosis of patients with chronic kidney disease. Most patients cannot achieve the control standard by controlling the phosphorus intake in the diet, so they need to use phosphorus binders to achieve the control purpose. Even when dialysis treatment is initiated in the late stages of chronic kidney disease...

Claims

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Application Information

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IPC IPC(8): C08G73/00
CPCC08G73/00
Inventor 温少鹏吕志涛宋文同姚松芝
Owner SHANDONG CHENGCHUANG PHARMA R&D
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