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A kind of preparation method of middle molecular weight hydroxyethyl starch

A technology of hydroxyethyl starch and molecular weight, which is applied in the field of medicine and chemical industry, can solve the problems of high production cost and low yield, and achieve the effects of short reaction time, high yield and easy control

Active Publication Date: 2018-10-09
HUAREN PHARMA (RIZHAO) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, the hydrolysis process is a key step in the entire production process, which will have a great impact on the molecular weight, its distribution, and the yield. The above-mentioned gradient three-stage temperature-changing process adopts a step-by-step cooling process. Disconnected, but this kind of gradient step-by-step cooling method can obtain medium molecular weight hydroxyethyl starch with narrow distribution, but the yield is as low as 45%, and the production cost is higher
[0010] The Chinese patent of patent No. CN102675477 B has announced a kind of preparation method that improves the yield of medium molecular weight hydroxyethyl starch, comprises the following steps: (1) amylopectin and hydrochloric acid are added in water and stirred evenly, are made into reaction solution, and reaction solution Heat and stir until the kinematic viscosity of the reaction solution is 16-24mm 2 Stop heating after / s, cool rapidly, add NaOH to be neutralized to reaction liquid in the cooling process and be neutral; The weight of amylopectin in every milliliter of water is 0.2~0.4g, and the concentration of HCl is 0.04~0.1mol / L, described Water is purified water; (2) sodium hydroxide is added in the reaction solution after step (1), and after vacuumizing, an etherification agent is added for etherification reaction, and water is diluted after the reaction; the etherification agent is epoxy Ethane; the addition of etherifying agent is: the molar ratio of pullulan and etherifying agent is 1:0.5~0.85, and the concentration of NaOH is 0.4~1.1mol / L; (3) adjust step (2) with concentrated hydrochloric acid The pH value of the obtained reaction solution is 5-7, adding medical injection charcoal for decolorization, suction filtration, and filtration; (4) ultrafiltration is performed on the solution obtained in step (3) with an ultrafiltration membrane until the conductivity of the solution is reduced to 1000~ 1100μs / cm, and then reduce the conductivity of the solution to 50-100μs / cm by electrodialysis, and finally perform fine filtration with a 0.22μm water film; (5) concentration by nanofiltration, and then spray drying to obtain medium molecular weight hydroxyethyl starch, Its yield can reach up to 44.5%; but there is still the problem of low yield
[0011] The current technology can obtain medium molecular weight hydroxyethyl starch with narrow distribution, but the yield is low, most of the literature reports do not exceed 50%, and the production cost is relatively high

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  • A kind of preparation method of middle molecular weight hydroxyethyl starch

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Embodiment 1

[0026] A kind of preparation method of middle molecular weight hydroxyethyl starch, disperses waxy cornstarch with purified water, hydrolyzes with inorganic acid; adopts gradient variable temperature control, uses Ping's viscometer to detect viscosity (t) to carry out hydrolysis degree control; hydrolyzate is passed through Etherification, decarburization filtration, ultrafiltration, decolorization, fine filtration and spray drying processes to obtain medium molecular weight hydroxyethyl starch, wherein the hydrolysis process is as follows:

[0027] Take 300kg of waxy corn starch, put it into 1000L of purified water, add 4L of 36% hydrochloric acid (W / V), stir and suspend it fully, then raise the temperature from room temperature to 70°C at a rate of 2°C / min, and keep it warm for 90 minutes; Heat up to 80°C at a rate of 1 / min and keep warm. Sampling every 10 minutes, control viscosity with Ping's viscometer: 1′35″ when hydrolysis ends, cool to below 60°C.

[0028] The hydroly...

Embodiment 2

[0031] A kind of preparation method of middle molecular weight hydroxyethyl starch, disperses waxy cornstarch with purified water, hydrolyzes with inorganic acid; adopts gradient variable temperature control, uses Ping's viscometer to detect viscosity (t) to carry out hydrolysis degree control; hydrolyzate is passed through Etherification, decarburization filtration, ultrafiltration, decolorization, fine filtration and spray drying processes to obtain medium molecular weight hydroxyethyl starch, wherein the hydrolysis process is as follows:

[0032] Take 270 kg of waxy cornstarch, put it into 1000 L of purified water, add 3.5 L of 69.2% nitric acid (W / V), stir and suspend it fully, raise the temperature from room temperature to 75 °C at a rate of 1.5 °C / min, and keep it warm for 80 minutes; The temperature was raised to 75°C at a rate of °C / min and kept warm. Sampling every 10 minutes, control viscosity with Ping's viscometer: 1'51" when hydrolysis ends, cool to below 60°C.

...

Embodiment 3

[0036] A kind of preparation method of middle molecular weight hydroxyethyl starch, disperses waxy cornstarch with purified water, hydrolyzes with inorganic acid; adopts gradient variable temperature control, uses Ping's viscometer to detect viscosity (t) to carry out hydrolysis degree control; hydrolyzate is passed through Etherification, decarburization filtration, ultrafiltration, decolorization, fine filtration and spray drying processes to obtain medium molecular weight hydroxyethyl starch, wherein the hydrolysis process is as follows:

[0037] Take 320kg of waxy cornstarch, put it into 1000L of purified water, add 25L of 20% dilute sulfuric acid (W / V), stir and suspend it fully, raise the temperature from room temperature to 75°C at a rate of 1.5°C / min, and keep it warm for 80 minutes; The temperature was raised to 75°C at a rate of °C / min and kept warm. Sampling every 10 minutes, control the viscosity with Ping's viscometer: 1′43″ when the hydrolysis ends, cool to below...

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Abstract

The invention relates to the field of medicine and chemical engineering, especially to a preparation method of middle-molecular hydroxyethyl starch. The method comprises the following steps: dispersing waxy corn starch with purified water and hydrolyzing with inorganic acid; adopting gradient temperature change control and carrying out hydrolysis degree control by the use of a Ping's viscometer; etherifying a hydrolysate, decarbonizing and filtering, carrying out ultrafiltration, decolouring, carrying out fine filtration and spray-drying, etc. so as to obtain the middle-molecular hydroxyethyl starch. By the method, weight-average molecular weight control of the middle-molecular hydroxyethyl starch is more accurate, molecular weight distribution is more concentrated, and yield is obviously raised.

Description

technical field [0001] The invention relates to the field of medicine and chemical industry, in particular to a preparation method of 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 the body are weight average molecular weight and molecular weight distribution, molar substitution degree, and C2 / C6, among which the weight average molecular weight and molecular weigh...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B31/12
CPCC08B31/12
Inventor 舒文厉夫奎
Owner HUAREN PHARMA (RIZHAO) CO LTD