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Sevelamer carbonate crude drug for preparing tablets, preparation method and application thereof

A technology of sevelamer carbonate and wet products of sevelamer carbonate, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, pill delivery, etc., can solve the problem of compressibility of sevelamer carbonate tablets that have not been proposed Correlation and other issues, to avoid the risk of systemic absorption, low friability, smooth surface effect

Active Publication Date: 2013-01-30
NANJING LIFENERGY R & D +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] Although the above-mentioned documents have carried out certain research work on the compressibility of sevelamer carbonate raw material and its powder characteristics, the way to solve the compressibility of the raw material is to add a certain amount of specific functional excipients. It is realized by further restricting Sevelamer Carbonate powder or powder agglomerates; it has not proposed the relationship between the compressibility of Sevelamer Carbonate Tablets and the content of soluble oligomers and the characteristic particle size of its powder. connection relation

Method used

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  • Sevelamer carbonate crude drug for preparing tablets, preparation method and application thereof
  • Sevelamer carbonate crude drug for preparing tablets, preparation method and application thereof
  • Sevelamer carbonate crude drug for preparing tablets, preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0042] Preparation of Crude Sevelamer Carbonate

[0043] 1. Sevelamer hydrochloride 1kg, NaHC0 3 1kg and 20kg of water were added to the reaction vessel, stirred and reacted at about 60°C for 4h, and filtered.

[0044] 2. The solid obtained in step 1, 1kg NaHCO 3 Add 15kg of water into the reaction vessel, adjust the pH of the feed solution to 9.5 with NaOH, continue to stir and react for 4 hours at 60°C, and filter;

[0045] 3. Put the Sevelamer Carbonate obtained in step 2 into a washing tank, add an appropriate amount of purified water, stir, let it stand, and extract the supernatant, and repeat this until the conductivity is not greater than 30 μs / cm, and filter to obtain a wet product of Sevelamer Carbonate .

[0046] 4. The wet product of sevelamer carbonate was dried at 80°C for 16 hours to obtain 788 g of crude product of sevelamer carbonate, with a yield of 78.8%.

Embodiment 2

[0048] Preparation of Crude Sevelamer Carbonate

[0049] 1. Sevelamer hydrochloride 20kg, NaHCO 3 20kg and 160kg of water were added to the reaction vessel, stirred and reacted at 60°C for 4h, and the solid was collected by centrifugation.

[0050] 2, the solid obtained in step 1 and 20kg NaHCO 3 Add 240kg of water into the reaction vessel, adjust the pH of the feed solution to 10.8 with NaOH, continue stirring and reacting at 55-65°C for 4 hours, and collect the solid by centrifugation;

[0051] 3. Put the sevelamer carbonate obtained in step 2 into a washing tank, add an appropriate amount of purified water, stir, and centrifugally filter, repeat this until the conductivity of the eluate is not greater than 30 μs / cm, and then centrifuge to obtain a wet product of sevelamer carbonate .

[0052] 4. The wet product of sevelamer carbonate was dried in a hot air circulation oven at 80°C for 16 hours to obtain 17.4 kg of crude product of sevelamer carbonate, with a yield of 87....

Embodiment 3

[0054] Take the crude product of sevelamer carbonate (prepared in Example 2), pulverize it with a type 20 fluidized bed jet mill, the air pressure of the pulverizer is 0.7-1.0Mpa, the diameter of the classifying wheel is 0.2m, and the frequency of the classifying wheel is 10-40Hz; The carbonic acid sevelamer is tested for quality, and the results are listed in Table 1:

[0055] Table 1

[0056]

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Abstract

The invention belongs to the field of pharmacy, and relates to a sevelamer carbonate crude drug for preparing tablets, a preparation method and application of the sevelamer carbonate crude drug. The particle size of the sevelamer carbonate crude drug meets the conditions: D 0.95 is less than or equal to 180mu m, D 0.50 is less than or equal to 50mu m, and D 0.05 is more than or equal to 9mu m at the same time. The polyallylamine carbonate has the soluble oligomer (0.2%) within the particle size range. The tablets prepared from the sevelamer carbonate crude drug have the advantages of being smooth in surfaces, good in hardness and low in friability.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a sevelamer carbonate crude drug for preparing tablets, a preparation method and application thereof. Background technique [0002] It is well known that hyperphosphatemia is common in patients with end-stage renal disease, and hyperphosphatemia can cause hyperparathyroidism and osteodystrophy. Recent studies have found that hyperphosphatemia can still induce soft tissue and vascular calcification, which is an important factor for the increased mortality and cardiovascular disease in patients with end-stage renal disease. Therefore, effective control of serum phosphorus levels has become an important measure to reduce the mortality and incidence of cardiovascular diseases in patients with end-stage renal disease. At present, the treatment of hyperphosphatemia mainly includes dietary phosphorus restriction, dialysis treatment, application of phosphorus binders and removal of parathyroid gla...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/785C08F126/02C08F8/44C08J3/24A61P3/12A61P7/00
Inventor 方文胡良明沙伟叶静远汤传飞胡俊
Owner NANJING LIFENERGY R & D
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