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Preparation method of sevelamer carbonate

A technology of sevelamer carbonate and allylamine hydrochloride, which is applied in the field of preparation of sevelamer carbonate to achieve good formability and rapid disintegration

Inactive Publication Date: 2014-06-18
TIANJIN TAIPU PHARMA SCI & TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

After our research, it was found that the average molecular weight of compound I has a greater impact on the formulation performance of compound II, and this relationship has not been mentioned in the published literature

Method used

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  • Preparation method of sevelamer carbonate
  • Preparation method of sevelamer carbonate
  • Preparation method of sevelamer carbonate

Examples

Experimental program
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Embodiment 1

[0025] Dissolve 1 kg of polyallylamine hydrochloride with an average molecular weight of 12,000 in 4 L of water, add 284 grams of sodium hydroxide, then cool to room temperature, add 59 grams of epichlorohydrin, stir until viscous, and place at room temperature for 18 hours. Crush the reactant, suspend and stir the solid in 10L, 15L, and 20L water for 1 hour and filter, add 40-50% sodium hydroxide solution, adjust the pH to 13, then filter, suspend and stir in 20L water and add dry ice until the pH =9.0-9.9, filter, dry at 60°C until constant weight, obtain off-white solid, grind and sieve to obtain Sevelamer Carbonate (carbonate content 17.5%, phosphate binding capacity 5.7, cross-linking degree 16.1 %), using this sample to prepare tablets (refer to CN101043878A). The hardness of the obtained tablet is greater than 10kg, the surface is smooth, easy to coat, and the disintegration time is 68 seconds. ( The tablet hardness of batch D0054B01 is greater than 10kg, and the dis...

example 1

[0027] With reference to the method of Example 1, the use of polymerized allylamine hydrochloride with an average molecular weight of 7000 to prepare sevelamer carbonate (carbonate content 16.8%, phosphate binding capacity 6.4, degree of cross-linking 15.6%), this sample was carried out The preparation of tablet (simultaneously the description of embodiment 1), the tablet hardness obtained is greater than 10kg smooth surface, is easy to coat, and disintegration time is extended to 22 minutes.

Embodiment 3

[0029] With reference to the method of Example 1, the use of polymerized allylamine hydrochloride with an average molecular weight of 22000 prepares sevelamer carbonate (carbonate content 18.2%, phosphate binding capacity at 5.6, cross-linking degree 15.1%), the sample Carry out the preparation of tablet (simultaneously the description of embodiment 1), the tablet hardness obtained is less than 2kg, and surface is rough, is friable in coating process, and disintegration time is: 58 seconds.

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Abstract

The invention discloses a preparation method of sevelamer carbonate. The preparation method comprises the steps: dissolving polyallylamine hydrochloride with the average molecular weight of 8000-20000 in water, adding sodium hydroxide, then cooling to the room temperature, adding epoxy chloropropane, stirring until being viscous, and placing for 18-24 hours at the room temperature, wherein the weight part ratio of polyallylamine hydrochloride, sodium hydroxide and epoxy chloropropane is 1:0.2-0.8:0.2-0.8. Experimental results show that when the molecular weight of polyallylamine hydrochloride is in a range of 8000-20000, preferably in a range of 10000-15000, the prepared sevelamer carbonate has the advantages of good formability of tablets, high hardness and easy coating, moreover, has the disintegration time less than 3 minutes, can be fully mixed with food, reaches an effect of full complexation of phosphoric acid, and is more beneficial for patients to use.

Description

technical field [0001] The invention belongs to the technical field of medicine synthesis, and relates to the synthesis of medicines for reducing blood phosphorus, more specifically, a preparation method of sevelamer carbonate. Background of the invention [0002] Calcium and phosphorus maintain a delicate balance in the normal human body. They are all under the strict control of the kidneys, bones and endocrine system, and are absorbed, eliminated and flowed according to the needs of the human body. The bone acts as a huge and exchangeable calcium and phosphorus storage place, and it is also a supply and buffer place for these minerals. The balance of calcium and phosphorus in patients with chronic renal failure has been seriously damaged and affected, because the phosphorus in the diet cannot be absorbed into the body, and the phosphate in the body cannot be effectively eliminated, so that too much phosphate in the blood often leads to hyperphosphatemia. Compared with pat...

Claims

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Application Information

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IPC IPC(8): C08F126/02C08F8/44C08J3/24C08K5/1515A61P3/12
Inventor 孙继铨代奕阮长浩田迎春王伟赵健
Owner TIANJIN TAIPU PHARMA SCI & TECH DEV
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