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Method for preparing hydroxyethyl starch

A technology of hydroxyethyl starch and hydroxyethylation, applied in blood diseases, extracellular fluid diseases, drug combinations, etc., can solve the problems of reducing product quality, cumbersome preparation process, difficult control of starch molecular weight, etc., to avoid damage Effect

Inactive Publication Date: 2010-07-14
CHENGDU QINGSHAN LIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Through the analysis and comparison of different preparation methods, it is found that if the starch raw material is hydrolyzed first, and then the hydroxyethylation reaction is carried out, it is difficult to control the molecular weight of the starch during hydrolysis, because hydroxyethylation must be carried out after hydrolysis. , so it is necessary to estimate the degree of increase in molecular weight in advance, resulting in very inaccurate control of molecular weight
At the same time, it is very difficult to remove organic residues (such as ethylene oxide, ethylene glycol) after hydroxyethylation, which reduces the quality of the product. The entire preparation process is cumbersome and difficult to control the product quality.

Method used

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  • Method for preparing hydroxyethyl starch
  • Method for preparing hydroxyethyl starch
  • Method for preparing hydroxyethyl starch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Add 25 L of aqueous solution containing 95% (v / v) ethanol to the reaction kettle, add 0.25 kg of sodium hydroxide under stirring, add 10 kg of cornstarch (pH>13, the same below) after dissolving, seal the reaction kettle, and feed nitrogen into it Empty the air in the reaction kettle, add ethylene oxide, stir the reaction, add 2mol / L hydrochloric acid to neutralize to pH 6-8 after completion, filter and dry to obtain the hydroxyethylated starch intermediate.

[0024] Add 30L of 6% hydrochloric acid solution (pH ≤ 1, the same below) to the hydrolysis reaction kettle, add the above-mentioned intermediate under stirring, and after timing and stirring for 4 to 4.5 hours, neutralize to pH 6 with 5mol / L sodium hydroxide solution Add 0.05% (w / v) of activated carbon, keep stirring for 15 minutes, pass through a 1 μm titanium rod for decarbonization, then use a 10KD ultrafiltration membrane to ultrafilter and spray dry to obtain (HES 200 / 0.5) product. The comparison of this prod...

Embodiment 2

[0026]Add 50L of isopropanol solution to the reaction kettle, add 2.0kg of sodium hydroxide under stirring, add 10kg of cornstarch after dissolving, seal the reaction kettle, feed nitrogen to evacuate the air in the reaction kettle, after adding chloroethanol, in 30 ℃~35℃, stir the reaction, add 2mol / L hydrochloric acid to neutralize after completion, adjust the pH to 6~8, filter and dry.

[0027] Add 80L of 5% hydrochloric acid solution to the hydrolysis reaction kettle, heat up to 50°C-55°C, add the above-mentioned intermediate under stirring, and after timing and stirring for 6-6.5 hours, neutralize with 5mol / L sodium hydroxide solution to When the pH is about 6, add 0.3% (w / v) activated carbon, heat and stir for 15 minutes, pass through a 1 μm titanium rod for decarbonization, refine with absolute ethanol, and spray dry to obtain (HES 130 / 0.4) product. The comparison of this product with the same product (batch number C0502013A) of Germany Fresenius Kabi Co., Ltd. in molec...

Embodiment 3

[0029] Add 30L of 90% methanol aqueous solution in the reactor, add 0.5kg of sodium hydroxide under stirring, add cornstarch 10kg after dissolving, seal the reactor, pass into nitrogen to evacuate the air in the reactor, add ethylene oxide, At 20°C-25°C, after the stirring reaction is completed, add 2mol / L hydrochloric acid for neutralization, adjust the pH to 6-8, filter, and dry.

[0030] Add 50L of 10% hydrochloric acid solution to the hydrolysis reaction kettle. After heating up to 55°C-60°C, add the above-mentioned intermediate under stirring. After timing and stirring for 7-7.5 hours, neutralize with 5mol / L sodium hydroxide solution to When the pH is about 6, add 0.1% (w / v) activated carbon, heat and stir for 15 minutes, pass through a 1 μm titanium rod for decarbonization, ultrafilter with a 3KD ultrafiltration membrane, and spray dry to obtain a (HES 40 / 0.8) product.

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Abstract

The invention discloses a method for preparing hydroxyethyl starch. The starch raw materials are subjected to hydroxyethylation and acid hydrolysis treatment in a solvent medium respectively. The method for preparing the hydroxyethyl starch comprises the following steps: firstly, under the alkaline condition that the pH is 13-14, carrying out hydroxyethylation reaction by using ethylene oxide or chlorethanol in an amount which is 0.2 to 1.8 times mol of the starch as a hydroxyethylation reagent; secondly, hydrolyzing the starch raw materials which are subjected to the hydroxyethylation under the acidic condition that the pH is 1-3 to obtain the hydroxyethylation starch, wherein the weight-average molecular weight is 20 to 500kD; the molar degree of substitution is 0.1 to 0.9, and the substituted ratio at the C2 / C6 position is 3 to 20 and the substituted ratio at the C3 / C6 position is 0.1 to 8. The method for preparing the hydroxyethyl starch can prevent the starch structure from being damaged without pasting the starch, solve the problems that the control of the molecular weight of the products is inaccurate during acid hydrolysis, an organic residual solvent which is subjected to the hydroxyethylation is hardly removed and the like, and is favorable for industrialized production. Therefore, hydroxyethylation starch products with different molecular weights and / or degrees of substitution can be obtained.

Description

technical field [0001] The invention relates to a preparation method of hydroxyethyl starch. Background technique [0002] Hydroxyethyl starch (HES) is used for blood volume expansion in clinical treatment and has become an irreplaceable plasma substitute. [0003] The physiological and chemical properties of hydroxyethyl starch are mainly determined by parameters such as weight average molecular weight (Mw), degree of substitution (Ms) and substitution mode. For example: the clinical effect is confirmed, hydroxyethyl starch 200 / 0.5 (that is, the weight average molecular weight is 200kD, the average molar substitution degree of glucose residue is 0.5 (allowable range 0.43 ~ 0.55), and the substitution ratio of C2 / C6 position is 5: 1) The expansion effect can reach 100%, the expansion time is 4-8 hours, the half-life is 3-4 hours, the allergic reaction is low, and it has the function of preventing and blocking capillary leakage. It can also reduce the release of vasoactive ...

Claims

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Application Information

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IPC IPC(8): C08B31/10A61P7/08
Inventor 徐世兰欧苏陶渊崔盛
Owner CHENGDU QINGSHAN LIKANG PHARMA CO LTD
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