Preparation process of sevelamer carbonate

A technology for the preparation of sevelamer carbonate, which is applied in the fields of metabolic diseases, blood diseases, extracellular fluid diseases, etc., can solve the problem of low incidence of gastrointestinal side effects, improve product quality, improve product quality, The effect of reducing labor intensity

Inactive Publication Date: 2016-07-06
JIANGSU TIANHE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinical comparison has confirmed that Sevelamer Carbonate and Sevelamer Hydrochloride are equally effective in controlling serum phosphorus levels in chronic kidney disease patients undergoing dialysis, but individuals treated with Sevelamer Carbonate are more likely to maintain an appropriate bicarbonate level, so Lower incidence of gastrointestinal side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] (1) with 50kg of allylamine hydrochloride aqueous solution as raw material, wherein the mass percent of allylamine hydrochloride is 60%, in the raw material, add initiator V50 (azobisisobutyramidine hydrochloride) 500 ~625g, carry out the first polymerization reaction under the temperature condition of 50℃~55℃ for 24 hours, then add 500~625g of initiator again, carry out the second polymerization reaction under the temperature condition of 54℃~60℃, and polymerize allylamine For polyallylamine hydrochloride.

[0028] (2) 40kg of polyallylamine hydrochloride was added to the dissolving tank, 400kg of purified water was added, stirred and dissolved to a colorless clear liquid, then slowly added sodium hydroxide, stirred and neutralized to pH 12, and obtained polyallylamine hydrochloride salt solution.

[0029] (3) in the polyallylamine hydrochloride solution, adding mass percent is the acetonitrile solution of 50% epichlorohydrin, wherein the mol ratio of the acetonitrile...

Embodiment 2

[0035] (1) Prepare polyallylamine hydrochloride by the method in Example 1.

[0036] (2) 40kg of polyallylamine hydrochloride was added to the dissolving tank, 260kg of purified water was added, stirred and dissolved to a colorless clear liquid, then slowly added sodium hydroxide, stirred and neutralized to pH 10, and obtained polyallylamine hydrochloride salt solution.

[0037] (3) in polyallylamine hydrochloride solution, adding mass percent is the tetrahydrofuran solution of 50% epichlorohydrin, wherein the mol ratio of the acetonitrile solution of polyallylamine hydrochloride and epichlorohydrin is 9.5:1, After stirring for 30 minutes, it was put into a curing tank and kept at 25° C. and left for curing reaction for 20 hours to obtain a polymer gel.

[0038] (4) Grind the polymerized colloid to 50 meshes with a colloid mill, add 320 kg of an aqueous sodium hydroxide solution with a mass percentage of 4%, stir for 1 hour under the condition that the temperature of the mixt...

Embodiment 3

[0043] (1) Prepare polyallylamine hydrochloride by the method in Example 1.

[0044] (2) 40kg of polyallylamine hydrochloride was added to the dissolving tank, 320kg of purified water was added, stirred and dissolved to a colorless clear liquid, then slowly added sodium hydroxide, stirred and neutralized to pH 12, and obtained polyallylamine hydrochloride salt solution.

[0045] (3) in polyallylamine hydrochloride solution, adding mass percent is the tetrahydrofuran solution of 50% epichlorohydrin, wherein the mol ratio of the acetonitrile solution of polyallylamine hydrochloride and epichlorohydrin is 9: 1; After stirring for 20 minutes, it was then put into a curing tank and kept at 30° C. for a static curing reaction for 16 hours to obtain a polymer gel.

[0046] (4) Grind the polymerized colloid to 50 meshes with a colloid mill, add 240 kg of an aqueous sodium hydroxide solution with a mass percentage of 4%, stir for 1.5 hours under the condition that the temperature of t...

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PUM

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Abstract

The invention relates to the technical field of production of sevelamer carbonate. Add an acetonitrile solution of epichlorohydrin to the solution of polyallylamine hydrochloride in proportion, and obtain a polymerized jelly after curing; after polymerization, the jelly is ground to 50 mesh by a colloid mill and then added 4% Hydroxide Sodium aqueous solution, stirred and reacted to obtain sevelamer base; finally, purified water was added to the sevelamer base, the temperature was raised, carbon dioxide was fed in, the mixture was kept warm, stirred and reacted, centrifuged and dried to obtain sevelamer carbonate. Adopting the preparation process of the sevelamer carbonate of the present invention can greatly reduce product energy consumption, improve product quality, and solve the problem of waste water generation; meanwhile, it can also reduce labor intensity and improve labor productivity. To improve product quality, the qualified rate of finished products reached 99.6%, and the yield reached 64.7%.

Description

technical field [0001] The invention relates to the technical field of production of sevelamer carbonate. Background technique [0002] Sevelamer carbonate, alias 2-propen-1-amine and epichlorohydrin polymer carbonate, molecular formula: (C 3 H 7 N)m.(C 3 H 5 ClO)n.(CH 2 O 3 )x. Sevelamer, for the treatment of hyperphosphatasia in chronic kidney disease dialysis patients. The original researcher of the drug is Genzyme (now Sanofi), and its hydrochloride capsule was approved by the US FDA in 1998, and its hydrochloride tablet (Renagel 400mg & 800mg) was launched in 2000. In 2007, its second-generation product carbonate tablet (Renvela 800mg) was approved for marketing. [0003] The currently marketed preparations of sevelamer carbonate are tablets with a size of 800 mg. For the control of serum inorganic phosphorus and calcium levels and secondary hyperparathyroidism in patients with chronic renal failure during hemodialysis. Sevelamer carbonate acts as a calcium- a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08F126/02C08F8/44C08J3/24C08K5/1515A61K31/785A61P3/12A61P7/08
CPCC08F126/02A61K31/785C08F8/44C08J3/24C08J2339/02C08K5/1515
Inventor 杨南松赵云德韩雨田朱林飞
Owner JIANGSU TIANHE PHARMA CO LTD
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