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Icodextrin and its preparation method

A technology of icodextrin and reaction solution, which is applied in the field of icodextrin and its preparation, can solve the problems that did not mention the preparation method of icodextrin, and achieve the effect of concentrated molecular weight and narrow distribution range

Active Publication Date: 2015-08-26
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

None of the above-mentioned documents mentions the specific preparation method of icodextrin, and the description about the preparation of high molecular polysaccharide or dextran is relatively general

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] A preparation method of icodextrin, comprising the following steps:

[0036] A. Hydrolysis: After preparing cornstarch and water into a solution with a substrate concentration of 35wt%, adding hydrochloric acid to form a reaction solution, the final concentration of the hydrochloric acid is 0.51% (V / V), and at a temperature of 85°C, Carry out the hydrolysis reaction, need to carry out real-time monitoring to the reaction process simultaneously in the course of the hydrolysis reaction to determine the appropriate timing of terminating the hydrolysis reaction, when the reaction solution is measured with an Ubbelohde viscometer with a capillary inner diameter of 0.9-1.0mm, the outflow time is 2min54s At ±2s, neutralize the reaction solution to pH7 with sodium hydroxide solution, terminate the hydrolysis reaction, and obtain product 1, and the reaction time is 2.5h;

[0037] B. Molecular weight screening: carry out molecular weight screening on the product 1, dilute the pro...

Embodiment 2

[0041] A preparation method of icodextrin, comprising the following steps:

[0042]A. Hydrolysis: after preparing wheat starch and water into a solution with a substrate concentration of 20wt%, adding nitric acid to form a reaction solution, the final concentration of nitric acid is 0.365% (V / V), and at a temperature of 75°C, Carry out the hydrolysis reaction, need to carry out real-time monitoring to the reaction process simultaneously in the hydrolysis reaction process to determine the appropriate timing of terminating the hydrolysis reaction, when the reaction solution is measured by an Ubbelohde viscometer with a capillary inner diameter of 0.9-1.0mm, the outflow time is within 2 -3min, and according to the "Chinese Pharmacopoeia" 2010 edition, when the optical rotation of the reaction solution is measured at 0.57 ± 0.5, the reaction solution is neutralized to pH 7, the hydrolysis reaction is terminated, and the product 1 is obtained. The reaction time is 3.5h;

[0043] B...

Embodiment 3

[0047] A preparation method of icodextrin, comprising the following steps:

[0048] A. Hydrolysis: After preparing potato starch and water into a solution with a substrate concentration of 45wt%, adding sulfuric acid to form a reaction solution, the final concentration of the sulfuric acid is 0.73% (V / V), and at a temperature of 90°C, Carry out hydrolysis reaction, need to carry out real-time monitoring to reaction progress simultaneously in the hydrolysis process to determine the appropriate timing of termination reaction, when the reaction liquid is measured with Ubbelohde's viscometer with capillary inner diameter of 0.9-1.0mm, the outflow time is 2-3min , and tested with iodine test solution, when the iodine test solution was pale yellow, the reaction solution was neutralized to pH7 with potassium hydroxide solution, the hydrolysis reaction was terminated, and the product 1 was obtained, and the reaction time was 1h;

[0049] B. Molecular weight screening: carry out molecu...

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Abstract

The invention discloses an icodextrin and a preparing method thereof. The preparing method comprises the first step of mixing cereal starch and water into a solution with the substrate concentration ranging from 20wt% to 50wt%, and adding acid to the mixture of the cereal starch and the water to form a reaction solution, wherein the final concentration of the acid ranges from 0.1% to 1.5% (V / V), the hydrolysis reaction is carried out at the temperature ranging from 70 DEG C to 93 DEG C, the reaction process is monitored at the same time, when the flow-out time duration of the reaction solution, measured with an Ubbelohde viscometer with the internal diameter of a capillary tube being 0.9mm to 1.0mm, is 2-4 minutes, the reaction solution is neutralized to pH7 through the aqueous alkali, the hydrolysis reaction is ended to obtain a product 1, and the reaction duration ranges from 0.5 hour to 4 hours; the second step of carrying out molecular weight screening on the product 1 to obtain a product 2 with the weight-average molecular weight ranging from 13 thousand Da to 19 thousand Da; the product 2 is dried and solidified to obtain the icodextrin. The distribution range of the molecular weight of the icodextrin is narrower, and the molecular weight distribution is more centralized.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to an icodextrin and a preparation method thereof. Background technique [0002] Icodextrin is the main active ingredient in icodextrin peritoneal dialysis solution, which is used for the treatment of end-stage renal disease. It was first developed by the American ATTELION company and was approved by the FDA in 2002 by Baxter Medical. And Baxter's new peritoneal dialysis fluid, Icodextrin, was approved for marketing in Japan on July 18, 2003. Extraneal has been approved for marketing in 36 countries, including Taiwan and the United States recently. But there is only one simple sentence about the preparation of icodextrin: starch is hydrolyzed under the action of acid to prepare icodextrin. There is currently no patent on the preparation and production process of icodextrin API. In the existing literature about icodextrin peritoneal dialysis solution, respectively described: a k...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B30/18
Inventor 孙得艳李继仁叶芳
Owner HUAREN PHARMACEUTICAL CO LTD
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