Industrial production method of icodextrin

A production method, icodextrin technology, applied in the pharmaceutical field, can solve problems such as poor quality and increased production costs, and achieve the effects of improving quality, increasing the degree of hydrolysis, and shortening the time-consuming process

Active Publication Date: 2015-12-09
四川博佳制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The molecular mass distribution of the hydrolyzate obtained by the preparation method is relatively wide, and both a small molecular weight cut-off (5000Da) ultrafiltration membrane and a large molecular weight cut-off (100KDa) ultrafiltration membrane are required whe

Method used

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  • Industrial production method of icodextrin
  • Industrial production method of icodextrin
  • Industrial production method of icodextrin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The preparation of embodiment 1 icodextrin of the present invention

[0030] a. prepare the acid solution whose concentration of hydrochloric acid is 0.6%;

[0031] b. Take 1000 parts by weight of the acid solution, add 400 parts by weight of cornstarch under stirring, the hydrolysis temperature is 90°C, and after 2 hours of hydrolysis reaction, adjust the pH to 6 to obtain a hydrolyzate;

[0032] c. Cool the hydrolyzate prepared in step b to 55° C., add 12 parts by weight of activated carbon, decolorize for 0.5 hours, and filter after decolorization;

[0033] d. Ultrafiltration and drying of the filtrate prepared in step c, to obtain final product.

[0034] The obtained sample had a molecular weight (MW) of 16,800 Da and a water content of 3.86%.

Embodiment 2

[0035] Embodiment 2 The preparation of icodextrin of the present invention

[0036] a. prepare the acid solution whose concentration of hydrochloric acid is 0.9%;

[0037] b. Take 1000 parts by weight of the acid solution, add 450 parts by weight of cornstarch under stirring, and the hydrolysis temperature is 90 to 95 ° C. When the reaction solution is measured at 2 minutes by a Pinnacle viscometer with a capillary inner diameter of 0.6 mm, adjust When the pH reaches 5.5, the hydrolysis is terminated, and the hydrolyzed product is obtained, and the hydrolysis reaction time is 1.2h

[0038] c. Cool the hydrolyzate prepared in step b to 55-60°C, add 13.5 parts by weight of activated carbon, decolorize for 1 hour, and filter after decolorization;

[0039] d. Ultrafiltration and drying of the filtrate prepared in step c, to obtain final product.

[0040] The obtained sample had a molecular weight (MW) of 14,600 Da and a water content of 3.94%.

Embodiment 3

[0041] Embodiment 3 Preparation of icodextrin of the present invention

[0042] a. prepare the acid solution whose concentration of hydrochloric acid is 1.2%;

[0043] b. Take 1000 parts by weight of the acid solution, add 450 parts by weight of cornstarch under stirring, the hydrolysis temperature is 95°C, and after 1.0 hours of hydrolysis reaction, adjust the pH to 5.5 to obtain a hydrolyzate;

[0044] c. Cool the hydrolyzate prepared in step b to 55° C., add 13.5 parts by weight of activated carbon, decolorize for 1 hour, and filter after decolorization;

[0045] d. Ultrafiltration and drying of the filtrate prepared in step c, to obtain final product.

[0046] The obtained sample had a molecular weight (MW) of 13,800 Da and a water content of 3.86%.

[0047] The beneficial effects of the present invention are demonstrated through specific experiments below.

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Abstract

The invention provides an industrial production method of icodextrin. The industrial production method comprises steps as follows: a, an acid solution with the concentration of 0.3%-1.5% is prepared; b, 1,000 parts by weight of the acid solution are taken, 400-450 parts by weight of corn starch are added to the acid solution during stirring, the mixture has a hydrolysis reaction for 1-2 h at the hydrolysis temperature of 90-95 DEG C, and then pH is regulated to 5-7, and a hydrolysis product is obtained; c, the hydrolysis product prepared in the step b is cooled to 55-60 DEG C, 12-13.5 parts by weight of activated carbon is added, decoloration is performed for 0.5-1 h, and filtration is performed after decoloration; d, a filtrate prepared in the step c is subjected to ultrafiltration and drying, and icodextrin is obtained. According to the industrial production method of icodextrin, the preparation process is simple, the production cost is low, a prepared product has good quality, and the industrial production method is applicable to industrial mass production of icodextrin.

Description

technical field [0001] The invention relates to an industrial production method of icodextrin, which belongs to the field of medicines. Background technique [0002] Icodextrin is a water-soluble glucose polymer linked by starch derivatives through α(1-4) and less than 10% α(1-6) glycosidic bonds, weight-average molecular weight is 13000-19000 Daltons, quantity- The average molecular weight is 5000-6500 Daltons. Icodextrin is the main active ingredient in icodextrin peritoneal dialysis fluid, which is used for the treatment of end-stage renal disease. Since the launch of icodextrin peritoneal dialysis solution, although more than 19,000 patients in more than 45 countries have benefited from it, among them, as many as one-third of patients in European countries use a bag of icodextrin peritoneal fluid every day However, the utilization rate of peritoneal dialysis in my country is still very low (about 10%) at present, which is related to the preparation price, production equ...

Claims

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Application Information

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IPC IPC(8): C08B30/18
Inventor 朱贞华苏丹丹罗清华任秀如白跃芳丁侃
Owner 四川博佳制药有限公司
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