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Amylopectin pretreatment method and use thereof

A pullulan and pretreatment technology, applied in the preparation of medium molecular weight hydroxyethyl starch, in the field of medium molecular weight hydroxyethyl starch, can solve the problems of inappropriate removal of bacterial endotoxin, impact on yield, loss of main drug components, etc. Achieve the effect of reducing the level of bacterial endotoxin, improving the internal quality of products, and having no occupational hazards

Active Publication Date: 2013-04-10
NEW FOUNDER HLDG DEV LLC +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] 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 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.
[0010] Although the ultrafiltration method can remove a large amount of bacterial endotoxins, for medium molecular weight hydroxyethyl starch, due to the molecular weight distribution (15000-400000) and bacterial endotoxin molecular weight distribution (thousands to hundreds of thousands) of the product have different Larger parts overlap, so this method is also extremely inappropriate for removing bacterial endotoxins in liquid medicine

Method used

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  • Amylopectin pretreatment method and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] 1. Amylopectin pretreatment method

[0061] Add 200L of positive ion water and 100kg of amylopectin into the mixing tank, start stirring to mix the two evenly, keep warm at 30°C for 15 minutes, then centrifuge and wash the filter cake with 100L of positive ion water. Processed amylopectin.

[0062] 2. The preparation process of medium molecular weight hydroxyethyl starch

[0063] 1) Hydrolysis

[0064] Add 500L of purified water and 5L of hydrochloric acid solution (36%-38%) into the hydrolysis tank, start stirring, then add the pretreated amylopectin, after stirring evenly, turn on steam heating to maintain the temperature in the tank at 82-92°C, Use the viscosity method to control the hydrolysis process, and stop the hydrolysis when the hydrolysis meets the process requirements.

[0065] 2) Etherification

[0066] First, dissolve 16Kg of solid sodium hydroxide in 200L of purified water to make a solution, stir and cool the above acid hydrolyzed material to 25°C, a...

Embodiment 2

[0079] 1. Amylopectin pretreatment method

[0080] Add 500L of positive ion water and 100kg of amylopectin into the mixing tank, start stirring to mix them evenly, keep warm at 30°C for 15 minutes, then centrifuge and wash the filter cake with 200L of positive ion water. Processed amylopectin.

[0081] 2. The preparation process of medium molecular weight hydroxyethyl starch

[0082] With embodiment 1.

[0083] 3. Detection method

[0084] With embodiment 1.

[0085] The specific experimental results are shown in Table 1 below.

Embodiment 3

[0087] 1. Amylopectin pretreatment method

[0088] Add 800L of positive ion water and 100kg of amylopectin into the blending bucket, start stirring to mix the two evenly, keep warm at 30°C for 15 minutes, then centrifuge and wash the filter cake with 500L of positive ion water. Processed amylopectin.

[0089] 2. The preparation process of medium molecular weight hydroxyethyl starch

[0090] With embodiment 1.

[0091] 3. Detection method

[0092] With embodiment 1.

[0093] The specific experimental results are shown in Table 1 below.

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Abstract

The present invention provides an amylopectin pretreatment method and use thereof. The method comprises: a) mixing the amylopectin with positive ion water so that bacterial endotoxin in the amylopectin is dissolved in the positive ion water; and b) separating the solid phase and the liquid phase of the mixing system formed by step a) to collect the solid phase, so the amylopectin after pretreatment is obtained. The present invention also provides a method for preparing hydroxyethyl starch of middle molecular weight and hydroxyethyl starch of middle molecular weight obtained by the method. The method for preparing hydroxyethyl starch of middle molecular weight provided by the present invention includes the beneficial effect that: the method can help to reduce the bacterial endotoxin content in the finished product and greatly improve the intrinsic quality of the product. The method is easy to operate, low in equipment and facility investment, low in energy consumption, and pollution-free, has no occupational hazards, does not affect the yield, and is stable in the finished product quality, convenient and easy to implement, and suitable for industrial production.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a pretreatment method of amylopectin and its application, a preparation method of medium molecular weight hydroxyethyl starch and medium molecular weight hydroxyethyl starch obtained by the method. Background technique [0002] Medium molecular weight hydroxyethyl starch is a new type of blood volume expander, its molecular weight distribution is concentrated at 110,000-150,000 Daltons, the range of substitution degree is 0.36-0.45, and the substitution mode is 9:1. The optimized combination of the above three makes it compared with 706, gelatin, low-molecular dextran and other older generation products, middle molecular hydroxyethyl starch has been obtained with its stable expansion effect, lower side effects and better clinical safety. It is favored by the majority of clinical anesthesia, surgery and ICU doctors, showing a good application prospect. [0003] Medium molecula...

Claims

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Application Information

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IPC IPC(8): C08J3/00C08L3/12C08B31/12
Inventor 赵德徐卫东王勇
Owner NEW FOUNDER HLDG DEV LLC
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