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Method for preparation of hydroxyethyl starch

A technology of hydroxyethyl starch and corn starch, applied in the field of medicine, can solve the problems of unqualified bacterial endotoxin in the product, easy growth of bacteria in the feed liquid, affecting production efficiency, etc., to avoid secondary pollution, easy filtration, and improved production efficiency. Effect

Active Publication Date: 2009-04-08
赤峰迪生药业有限责任公司
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Problems solved by technology

That is, in the decolorization process, when activated carbon is added, the feed liquid becomes viscous and the fluidity becomes poor; when filtering, it is difficult for several tons of feed liquid to pass through the filter in a short time, and it often takes 8-12 hours (production Low efficiency), the feed liquid is easy to grow bacteria (easy to cause unqualified product bacterial endotoxin, etc.); in addition, activated carbon is easy to leak from the filter (replacing the filter, re-filtering the feed liquid, seriously affecting production efficiency and production quality); moreover, activated carbon filter After removal, its adsorption of colored substances, bacteria, bacterial endotoxins and other impurities will be terminated immediately (this is also one of the possible factors that affect the appearance color of the product and the unqualified bacterial endotoxins)

Method used

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  • Method for preparation of hydroxyethyl starch
  • Method for preparation of hydroxyethyl starch
  • Method for preparation of hydroxyethyl starch

Examples

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Effect test

experiment example 1

[0054] Experimental example 1. is to study specific examples 1, 2, 3, 4, 5 of the present invention and comparative example 1, 2 bacterial endotoxin

[0055] 1. Bacterial endotoxin inspection method Take this product and inspect according to the law (Appendix XI E of Part Two of the Chinese Pharmacopoeia 2005 Edition), the amount of endotoxin contained in each 1g should be less than 8.0EU.

[0056] Table 2. Bacterial endotoxin comparison results of specific examples 1, 2, 3, 4, 5 and comparative examples 1, 2

[0057]

[0058] 2. Experimental results: the above experiment shows that the applicable concentration range of 10% sodium hypochlorite solution is 50-200ppm. Experimental example 2. is to study the character of specific embodiment of the present invention and comparative example

experiment example 2

[0058] 2. Experimental results: the above experiment shows that the applicable concentration range of 10% sodium hypochlorite solution is 50-200ppm. Experimental example 2. is to study the character of specific embodiment of the present invention and comparative example

[0059] 1. Character inspection: visual inspection (the 2005 edition of Chinese Pharmacopoeia stipulates the color and appearance of the drug)

[0060] 2. Standard: The national drug standard of this product is white or off-white powder

[0061] Table 3. The character comparative result of specific embodiment 1,2,3,4,5 and comparative example 1,2

[0062]

[0063] 3. Results: The color of Comparative Example 1 and Example 1 does not meet the standard requirements, and the color of the remaining examples is off-white or white and meets the standard requirements.

[0064] Post-acid hydrolysis embodiment as attached figure 2 As shown, 300kg of medical grade cornstarch, add 850kg of purified water, boil, ke...

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Abstract

The invention provides a new technology for preparing raw materials of hydroxyethyl starch, which uses 50PPM to 200PPM sodium hypochlorite for decolorization and sterilization and substitutes the traditional technology using active carbon for decolorization, thus improving the production efficiency and the quality of the hydroxyethyl starch. The new technology overcomes such defects of the traditional technology using active carbon for decolorization as viscous material liquid, poor fluidity, long filtration time of material liquid, easy growth of bacteria in the material liquid, easy leakage of the active carbon from a filter and the like, thus not only greatly shortening the filtration time, but also guaranteeing the produced raw materials of hydroxyethyl starch to have stable batch and reliable quality and to meet the national standard.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for preparing hydroxyethyl starch. Background technique [0002] Hydroxyethyl starch is obtained from the derivatization reaction of pullulan. Its chemical structure is similar to polysaccharides and glycogen in the body, and its side effects are smaller than plasma substitutes such as gum arabic and sodium alginate. Moreover, due to the existence of the hydroxyethyl group, on the one hand, it reduces the degradation rate of hydroxyethyl starch by amylase in the body, making it have a certain anti-shock effect; Solubility in order to prepare a solution of a certain concentration for clinical use. Therefore, hydroxyethyl starch solution is currently a commonly used plasma substitute in clinical practice. According to the molecular weight and the degree of substitution of hydroxyethyl starch, hydroxyethyl starch can be divided into: low molecular weight and high substit...

Claims

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Application Information

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IPC IPC(8): C08B31/12
Inventor 张竹林葛求富郑文郭殿武陈光荣
Owner 赤峰迪生药业有限责任公司
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