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Preparation method of icodextrin for starch-based peritoneal dialysis solution

A peritoneal dialysate and icodextrin technology, applied in the field of starch dextrin preparation, can solve the problems of large measurement method error, α-1,6 glycosidic bond ratio control, no specific method for icodextrin preparation, etc. , to achieve the effect of narrow distribution range and high purity

Active Publication Date: 2017-02-15
SOUTH CHINA UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the existing literature on icodextrin peritoneal dialysis solution, only about the application of icodextrin in peritoneal dialysis solution, and compared with other osmotic agents, this macromolecular polysaccharide osmotic agent has clinical advantages. Some advantages and current difficulties, but no specific method for the preparation of icodextrin
Chinese invention patent 2013104530981 introduces the acid hydrolysis preparation method of icodextrin, but this method uses an Ubbelohde viscometer to measure the weight average molecular weight, the measurement method has large errors, and the number average molecular weight is not measured , the point is that there is no regulation of the ratio of α-1,6 glycosidic bonds

Method used

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  • Preparation method of icodextrin for starch-based peritoneal dialysis solution
  • Preparation method of icodextrin for starch-based peritoneal dialysis solution
  • Preparation method of icodextrin for starch-based peritoneal dialysis solution

Examples

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Effect test

Embodiment 1

[0035](1) Prepare cornstarch with phosphate buffer solution to form a starch solution with a mass percent concentration of 15%, and adjust the pH to 7.8, place it in an airtight container, and stir and gelatinize at 99°C for 60 minutes; after gelatinization is completed, cool To 95°C, add high temperature resistant α-amylase (Liquozyme Supra, Novozymes company), the dosage is 8 U of high temperature resistant α-amylase per gram of dry starch, enzymatic hydrolysis for 1 min, adjust the pH to 2.5, and keep for 10 min to inactivate the enzyme activity, obtain the starch solution after enzymolysis;

[0036] (2) Add pullulanase (OPTIMAX L-1000, Genencor Bioengineering Co., Ltd.) to the starch solution after enzymolysis in step (1) at a pH of 5.5 and 60°C, and the dosage is 1 gram of dry starch Add 10 U of pullulanase, stir and react for 30 minutes; heat to 100°C for 10 minutes to inactivate the enzyme activity, and obtain the crude enzymatic hydrolyzate of peritoneal dialysate;

...

Embodiment 2

[0045] (1) Prepare wheat starch with a phosphate buffer solution to form a starch solution with a mass percent concentration of 5%, and adjust the pH to 5.8, place it in an airtight container, and stir and gelatinize at 95°C for 100 minutes; after the gelatinization is completed, cool To 70°C, add high temperature resistant α-amylase (Liquozyme Supra, Novozymes company), the dosage is 1 U of high temperature resistant α-amylase per gram of dry starch, enzymatic hydrolysis for 8 min, adjust the pH to 3.0, and keep for 15 min to inactivate the enzyme activity, obtain the starch solution after enzymolysis;

[0046] (2) Add isoamylase (Pseudomonas sp, Sigma-Aldrich company) to the starch solution after enzymolysis in step (1) at a pH of 6.5 and 50° C., in an amount of 2 U of isoamylase per gram of dry starch, Stir the reaction for 30 minutes; heat to 90°C for 15 minutes to inactivate the enzyme, and obtain the crude enzymatic hydrolyzate of the peritoneal dialysate;

[0047] (3) ...

Embodiment 3

[0052] (1) Prepare the waxy cornstarch with a phosphate buffer solution to form a starch solution with a mass percentage concentration of 5%, and adjust the pH to 7.0, place it in an airtight container, and stir and gelatinize at 95°C for 100 minutes; after the gelatinization is completed , cooled to 95°C, added high temperature resistant α-amylase (Liquozyme Supra, Novozymes company), the dosage was 8 U of high temperature resistant α-amylase per gram of dry starch, enzymatic hydrolysis for 3 minutes, adjusted pH to 2.7, and kept for 12 minutes to kill the enzyme live to obtain the starch solution after enzymolysis;

[0053] (2) Add pullulanase (OPTIMAX L-1000, Genencor Bioengineering Co., Ltd.) to the starch solution after enzymolysis in step (1) at a pH of 5.8 and 40°C, and the dosage is 1 gram of dry starch Add 8 U of pullulanase, stir for 40 minutes to react; heat to 95°C for 12 minutes to inactivate the enzyme activity, and obtain crude enzymatic hydrolyzate of peritonea...

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Abstract

The present invention discloses a preparation method of icodextrin for a starch-based peritoneal dialysis solution. According to the technical scheme of the invention, native starch is adopted as a raw material, and then a starch solution with the concentration thereof to be 5% to 15% is prepared by using a phosphate buffered solution. At a certain temperature and a certain pH value, the starch solution is firstly subjected to enzymolysis by using alpha-amylase, and then the gelatinized starch is subjected to debranching by using a debranching enzyme. The enzymatic hydrolysate is subjected to alcohol precipitation, ultrafiltration, gel chromatographic column separation and purification, and then the weight-average and number-average molecular weights thereof and the alpha-1, 6 glycosidic bond thereof meet the requirements at the same time. The content of alpha-1, 6 glycosidic bond in icodextrin is smaller than 10%, and the weight-average molecular weight thereof is 13000 to 19000 Da. The number-average molecular weight thereof is 5000 to 6500 Da. The preparation method of icodextrin for the starch-based peritoneal dialysis solution is high in yield, good in quality and relatively low in cost. Meanwhile, the defects of the conventional icodextrin preparation process in the prior art are overcome.

Description

technical field [0001] The invention relates to a method for preparing starch dextrin, in particular to a method for preparing starch-based peritoneal dialysis fluid by combining biotechnology, membrane filtration and column chromatography. Background technique [0002] Starch-based peritoneal dialysis fluid Icodextrin is the main active ingredient in icodextrin peritoneal dialysis fluid. Kidney dialysis is a simple, effective and cheap method, which is suitable for almost all ESRD patients. In my country, Hong Kong and Europe and other countries, more than 80% of dialysis patients choose peritoneal dialysis. Icodextrin (Icodextrin) is a water-soluble glucose polymer linked by corn starch through α-1,4 and less than 10% α-1,6 glycosidic bonds, with a weight average molecular weight of 13000-19000Da and a number average molecular weight of 5000 ~6500 Da. Icodextrin is used as a colloid osmotic agent to achieve ultrafiltration during long-term peritoneal dialysis indwelling....

Claims

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Application Information

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IPC IPC(8): C08B30/18A61P7/08
CPCC08B30/18
Inventor 罗志刚王萍萍杨庆余
Owner SOUTH CHINA UNIV OF TECH
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