Preparation method of narrow-distribution medium-molecular-weight hydroxyethyl starch

A technology of hydroxyethyl starch and molecular weight, applied in the field of medicine and chemical industry, can solve the problems of wide molecular weight distribution of hydroxyethyl starch, rapid change of starch weight-average molecular weight, difficult process control and the like

Active Publication Date: 2012-08-01
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the hydroxyethyl starch prepared by the above-mentioned constant temperature hydrolysis has a wide molecular weight distribution, which is far from that of the European Pharmacopoeia 7.0. It is still necessary to further control the weight average molecular weight and concentrate the molecular weight distribution.
In addition, in the existing literature, its hydrolysis temperature is relatively high, resulting in rapid changes in the weight average molecular weight of starch, and the process is not easy to control

Method used

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  • Preparation method of narrow-distribution medium-molecular-weight hydroxyethyl starch
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  • Preparation method of narrow-distribution medium-molecular-weight hydroxyethyl starch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1 Weight average molecular weight 100 000 ~ Preparation of 150 000 narrow distribution hydroxyethyl starches.

[0022] Hydrolysis: Take 300kg of waxy cornstarch, put it into 1 400L of purified water, add 6L of 36% hydrochloric acid (W / V), stir and suspend it fully, then raise the temperature from room temperature to 90°C at a rate of 2°C / min, and keep it warm for 90 minutes. Cool down to 80°C at a rate of 1°C / min and keep warm for 20 minutes. Then cool down to 70°C at a rate of 1°C / min and keep warm. Sampling every 10 minutes, using Ping's viscometer to control the kinematic viscosity: 20.5mm 2 / s. Cool to below 60°C.

[0023] Hydroxyethylation: Cool down the hydrolyzate to 22°C, add 1000mol of 4mol / L sodium hydroxide, and mix thoroughly. Into the container, pass into nitrogen replacement 3 times, pass into ethylene oxide 78kg. Mix well, and keep stirring at 30°C for 4 hours.

[0024] Decarburization and filtration: Add 36% hydrochloric acid (W / V) to t...

Embodiment 2

[0029] Example 2 Weight average molecular weight 100 000 ~ Preparation of 150 000 narrow distribution hydroxyethyl starches.

[0030] Hydrolysis: Take 500kg of waxy cornstarch, put it into 1400L of purified water, add 7L of 36% hydrochloric acid (W / V), stir and suspend it fully, raise the temperature from room temperature to 90℃ at a rate of 1℃ / min, and keep it warm for 80 minutes. Cool down to 80°C at a rate of 0.5°C / min and keep warm for 30 minutes. Then cool down to 70°C at a rate of 0.5°C / min and keep warm. Take samples every 10 minutes, and use Ping's viscometer to control the kinematic viscosity: 19.3mm 2 / s. Cool to below 60°C.

[0031] Hydroxyethylation: Cool down the hydrolyzate to 23°C, add 1000mol of 4mol / L sodium hydroxide, and mix well. Into the container, pass into nitrogen replacement 3 times, pass into ethylene oxide 77kg. Mix well, and keep stirring at 30°C for 4 hours.

[0032] Decarburization and filtration: Add 36% hydrochloric acid (W / V) to the h...

Embodiment 3

[0037] Example 3 Weight average molecular weight 150 000 ~ 300 000 Preparation of narrow distribution hydroxyethyl starch.

[0038] Hydrolysis: Take 300kg of waxy cornstarch, put it into 1400L of purified water, add 4L of 36% hydrochloric acid (W / V), stir well and suspend it, raise the temperature from room temperature to 90℃ at a rate of 1℃ / min, and keep it warm for 60 minutes. Cool down to 80°C at a rate of 1°C / min and keep warm for 30 minutes. Then cool down to 70°C at a rate of 1°C / min and keep warm. Sampling every 10 minutes, using Ping's viscometer to control the kinematic viscosity: 27.3mm 2 / s. After passing, cool to below 60°C.

[0039]Hydroxyethylation: Cool down the hydrolyzate to 24°C, add 1 000 mol of 4mol / L sodium hydroxide, and mix well. In the container, feed nitrogen replacement 3 times, and feed 83 kg of ethylene oxide. Mix well, and keep stirring at 30°C for 4 hours.

[0040] Decarburization and filtration: Add 36% hydrochloric acid (W / V) to the ...

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Abstract

The invention relates to the field of medical chemistry, in particular to a preparation method of narrow-distribution medium-molecular-weight hydroxyethyl starch. The method comprises the following steps of: dispersing wax corn starch with purified water, and hydrolyzing with an inorganic acid; performing gradient temperature change control and controlling the hydrolyzing degree by using dynamic viscosity; and performing hydroxyethylation, carbon removing filtration, ultrafiltration and spray drying on a hydrolysate to obtain a narrow-distribution medium-molecular-weight hydroxyethyl starch raw material. According to the method, the weight average molecular weight of the medium-molecular-weight hydroxyethyl starch is controlled more accurately, and the molecular weight distribution is more concentrated.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and relates to a preparation method of narrow distribution medium molecular weight hydroxyethyl starch. Background technique [0002] Plasma substitutes are used to improve the decrease in circulating blood volume caused by acute massive blood loss, extensive burns and scalds, severe vomiting and diarrhea. Currently commonly used plasma substitutes are hydroxyethyl starch, dextran, human serum albumin, oxidized polygelatin, and povidone. [0003] Hydroxyethyl starch (HES) has been used clinically as a plasma substitute in 1962, and has become the most concerned type of plasma substitute because of its good volume expansion effect and low side effects. The main factors affecting the metabolism of hydroxyethyl starch in vivo are weight average molecular weight and molecular weight distribution, molar substitution degree, C 2 / C 6 , where the weight-average molecular weight and molec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B35/04
Inventor 任传杰郑家晴冯波袁洪雨杜中海宋彦会于鹏
Owner SHANDONG QIDU PHARMA
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