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Purification method of hydroxyethyl starch

A technology of hydroxyethyl starch and a purification method, which is applied in the field of purification of hydroxyethyl starch, can solve problems such as the limitation of removing bacterial endotoxin, the loss of main drug components, and the impact on yield, so as to reduce the level of bacterial endotoxin and improve the internal Quality, easy-to-handle results

Inactive Publication Date: 2016-08-10
NEW FOUNDER HLDG DEV LLC +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Among them, although activated carbon adsorption has a good effect on adsorbing bacterial endotoxin and reducing the content of bacterial endotoxin in the liquid medicine, the adsorption will eventually reach a certain saturated adsorption capacity (≤75%), and if it is necessary to absorb more bacterial endotoxin The method of adding more activated carbon for the purpose of removing toxins will also cause the loss of the main drug components and affect the yield. Therefore, to reduce the bacterial endotoxins in the drug solution to a lower level, this method has its limitations.
[0013] Although ultrafiltration can remove a large amount of bacterial endotoxin, for hydroxyethyl starch (especially medium molecular weight hydroxyethyl starch), due to the molecular weight distribution of the product (15000-400000) and the molecular weight distribution of bacterial endotoxin ( Thousands to hundreds of thousands) have a large part of overlap, so this method is also limited in practical application for removing bacterial endotoxins in liquid medicine

Method used

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  • Purification method of hydroxyethyl starch
  • Purification method of hydroxyethyl starch

Examples

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preparation example Construction

[0053] A method for preparing hydroxyethyl starch, the method comprising: using sulfurous acid, bisulfite, and sulfite to help dissolve endotoxins, reducing the association of macromolecules such as endotoxins in water, and endotoxins are easily absorbed during ultrafiltration. remove;

[0054] Preferably, the sum of the concentrations of sulfurous acid, bisulfite and sulfite used for solubilization is 0.05-1.0 mol / L.

[0055] Preferably, the sulfurous acid, bisulfite, and sulfite used for solubilization can be one or more of sulfurous acid solution, sulfite, and bisulfite.

[0056] A specific embodiment of the present invention can be:

[0057] The purification method of hydroxyethyl starch of the present invention can be included in the preparation method of following hydroxyethyl starch, wherein, the preparation method of described medium molecular weight hydroxyethyl starch comprises the following steps:

[0058] 1) Starch hydrolysis: use purified water as solvent, disso...

example 1

[0078] 1) Hydrolysis

[0079] Add 3300ml of water to a 10L reaction kettle, stir, add 1000g of pharmaceutical grade starch, add 25ml of concentrated hydrochloric acid, heat up to 90°C, keep warm at 89-92°C, take samples every 10 minutes, and quickly measure the viscosity. At 1 minute and 25 seconds, stop heating and quickly cool down to 19-20°C.

[0080] 2) Etherification

[0081] Dissolve 35g of solid sodium hydroxide into 590ml of water and cool to 19-20°C. Slowly add the obtained NaOH solution into the hydrolysis mixture obtained in step 1) under stirring conditions, keep the temperature at 19-20°C, seal the etherification tank, vacuumize, slowly introduce 90g of ethylene oxide, and seal the reaction for 8 hours. The reaction is complete.

[0082] 3) Adsorption

[0083] Adjust the pH to 7.5 with concentrated hydrochloric acid. Under stirring, add 1750ml of mixed solvent of water and ethanol (volume ratio 1:3), stir fully, and let it stand; take the upper layer, use 15....

example 2

[0090] 1) Hydrolysis

[0091] Add 3500ml of water to a 10L reactor, stir, add 1000g of pharmaceutical grade starch, add 250ml of concentrated hydrochloric acid, heat up to 90°C, keep warm at 89-92°C, take samples every 10 minutes, and measure the viscosity quickly. At 1 minute and 20 seconds, stop heating and quickly cool down to 21-23°C.

[0092]2) Etherification

[0093] Dissolve 125g of solid sodium hydroxide into 700ml of water and cool to 19-20°C. Slowly add the obtained NaOH solution into the hydrolysis mixture obtained in step 1) under stirring conditions, keep the temperature at 21-23°C, seal the etherification tank, vacuumize, slowly introduce 115g of ethylene oxide, and seal the reaction for 5 hours. The reaction is complete.

[0094] 3) Adsorption

[0095] Adjust the pH to 5.5 with concentrated hydrochloric acid. Under stirring, add 2500ml of mixed solvent of water and ethanol (volume ratio 1:3), stir fully, and let it stand; take the upper layer, use 20.0g of ...

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Abstract

The invention provides a method for purifying hydroxyethyl starch. The method comprises the following steps: (1) mixing an aqueous solution of hydroxyethyl starch obtained by an activated carbon adsorption step in a hydroxyethyl starch preparation process with one or more than of sulfurous acid, hydrosulphite and sulfite, thereby obtaining a mixed solution; and (2) performing ultrafiltration on the mixed solution obtained in the step (1), separating, thereby obtaining the purified hydroxyethyl starch. The method disclosed by the invention has the positive effects that the method can reduce the content of bacterial endotoxin in the finished product hydroxyethyl starch, and the inherent quality of the product is greatly improved; the difference of molecular dimension in the finished hydroxyethyl starch is reduced, and the quality of the finished product is improved; and moreover, the method is easy to operate, pollution-free, rapid and easy to implement and suitable for industrial production, and the quality of the finished product is stable.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a method for purifying hydroxyethyl starch. Background technique [0002] Hydroxyethyl starch (HES) is usually used in patients with massive blood loss, and has the effect of inhibiting the aggregation of red blood cells in blood vessels; it is mainly used to improve microcirculation disorders, and it is clinically used in hypovolemic shock, such as hemorrhagic shock, burn and Thrombo-occlusive diseases such as shock during surgery. HES is able to preserve blood volume in patients while preventing their circulation from collapsing. Because hydroxyethyl starch itself is modified from starch, its structure is similar to glycogen, the incidence of allergies is much lower than that of dextran, there is no threat of hepatitis infection from biological products, and the treatment cost is low, so it is increasingly popular in clinic. [0003] The chemical name of hydroxyethyl starc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B31/12
Inventor 彭平郭萍张洪兰
Owner NEW FOUNDER HLDG DEV LLC
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