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Preparation method of extraneal

An icodextrin and a certain amount of technology, which is applied in the field of preparation of peritoneal dialysis fluid raw material - icodextrin, can solve the problems that peritoneal dialysis is difficult to carry out for a long time, the hydrolysis process is not easy to control, and the hydrogen spectrum has a large difference, so as to achieve convenience Depth of reaction, high yield, effect of controlling the depth of reaction

Inactive Publication Date: 2017-05-31
青岛力腾医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Regardless of acid hydrolysis or alkaline hydrolysis, the hydrolysis conditions are relatively severe, and the hydrolysis process is not easy to control. For example, acidic conditions can easily further degrade icodextrin into various products, resulting in the generation of advanced glycation end products (AGE), while AGEs can damage the peritoneum, making it difficult to perform peritoneal dialysis for a long time
In addition, the preparation of icodextrin by acid hydrolysis or alkaline hydrolysis is the branched chain (α-1,6 glycosidic bond) and linear chain (α-1,4 glycosidic bond) connection of randomly hydrolyzed starch, no specificity of selection, China Patent CN103467608 discloses a method of preparing icodextrin by using acid hydrolyzed starch, and our research found that the hydrogen spectrum of the product obtained by acid hydrolysis is quite different from that of the original product Extraneal, and has obvious structural differences

Method used

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Examples

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Effect test

Embodiment 1

[0022] A preparation method of icodextrin, comprising the following steps:

[0023] (1) Add a certain amount of cornstarch into purified water at 30°C to make the concentration reach 25wt%, perform 25KHz ultrasonic washing for 15min, then add a certain amount of lysozyme powder (0.2wt% of cornstarch), stir for 3h, and then Centrifuge, wash, and dry to obtain material A.

[0024] (2) Add material A to purified water at 60°C to make the concentration reach 25wt%, add a certain amount of debranching enzyme, stir for 3 hours, then heat up to 95°C, add a certain amount of calcium chloride and α-amylase, and stir Treat for 2 hours, add a certain amount of acetic acid and stir evenly, keep for 5 minutes to rapidly inactivate the enzyme, add a certain amount of sodium hydroxide solution to adjust the pH=6.0, and obtain material B. The consumption of described calcium chloride, acid is respectively 0.05%, 4% of material A weight; The consumption of described debranching enzyme, α-amyl...

Embodiment 2

[0030] A preparation method of icodextrin, comprising the following steps:

[0031] (1) Add a certain amount of cornstarch into purified water at 20°C to make the concentration reach 5wt%, perform 30KHz ultrasonic washing for 20min, then add a certain amount of lysozyme (0.1wt% of cornstarch), stir for 1h, and then proceed sequentially Centrifuge, wash, and dry to obtain material A.

[0032](2) Add material A to purified water at 50°C to make the concentration reach 5wt%, add a certain amount of debranching enzyme, stir for 4 hours, then heat up to 98°C, add a certain amount of calcium chloride and α-amylase, and stir Treat for 1 hour, add a certain amount of acetic acid and stir evenly, keep for 8 minutes to rapidly inactivate the enzyme, add a certain amount of sodium hydroxide solution to adjust the pH=5.5, and obtain material B. The consumption of described calcium chloride, acid is respectively 0.01%, 3% of material A weight; The consumption of described debranching enzy...

Embodiment 3

[0038] A preparation method of icodextrin, comprising the following steps:

[0039] (1) Add a certain amount of cornstarch into purified water at 40°C to make the concentration 40wt%, perform 20KHz ultrasonic washing for 10min, then add a certain amount of lysozyme (0.3wt% of cornstarch), stir for 6h, and then proceed Centrifuge, wash, and dry to obtain material A.

[0040] (2) Add material A to purified water at 65°C to make the concentration reach 40wt%, add a certain amount of debranching enzyme, stir for 2 hours, then heat up to 93°C, add a certain amount of calcium chloride and α-amylase, and stir Treat for 3 hours, add a certain amount of acetic acid and stir evenly, keep for 10 minutes to rapidly inactivate the enzyme, add a certain amount of sodium hydroxide solution to adjust the pH=6.5, and obtain material B. The consumption of described calcium chloride, acid is respectively 0.1%, 5% of material A weight; The consumption of described debranching enzyme, α-amylase i...

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Abstract

The invention relates to a preparation method of a peritoneal dialysis solution raw material-extraneal. The preparation method comprises the following steps: (1) adding lysozyme for treatment after washing starch; (2) after adopting debranching enzyme for hydrolysis, adding calcium chloride and alpha-amylase, and adding acid for rapidly deactivating the alpha-amylase after carrying out hydrolysis treatment; (3) adding modified activated carbon, and carrying out ultrasonic treatment; (4) carrying out molecular weight screening on a hydrolytic product in a filter solution C by using an ultra filtration membrane; (5) then adding the modified activated carbon, and filtering and drying after treatment, thus obtaining the extraneal. According to the preparation method of the extraneal, disclosed by the invention, the preparation efficiency and the yield are high, the pertinence is strong, reaction depth can be conveniently controlled, the hydrolytic product has good consistency with an originally-researched product, the generation of AGE (Advanced Glycation End Products) is completely eradicated, and peritoneal dialysis can be sustainably carried out.

Description

technical field [0001] The invention belongs to the technical field of preparation of pharmaceutical raw materials, and in particular relates to a preparation method of icodextrin, a peritoneal dialysate raw material. Background technique [0002] Native starch generally contains two components, namely amylose and amylopectin. Amylose is a linear molecule composed of glucose units connected by α-1,4 glycosidic bonds, with a reducing end and a non-reducing end. The linear chain of amylopectin is also connected by glucose units through α-1,4 glycosidic bonds, and branches are connected by α-1,6 glycosidic bonds at the branch points. Amylopectin has multiple non-reducing ends and one reducing end. Icodextrin (α-1,4-polyglucopyranose) is a product obtained by incomplete hydrolysis of starch, and is a hydrolyzate of amylopectin. Icodextrin can be mixed with other electrolytes to form a solution for clinical use in peritoneal dialysis. The icodextrin peritoneal dialysis solution...

Claims

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Application Information

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IPC IPC(8): C12P19/14C12P19/04
CPCC12P19/14C12P19/04
Inventor 徐展陈新阳孙建王文彦
Owner 青岛力腾医药科技有限公司
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