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A clean production method of medium molecular weight hydroxyethyl starch

A technology of hydroxyethyl starch and production method, which is applied in the field of medicine and chemical industry, can solve the problems of by-product generation and unsuitable hydroxyethyl starch raw material medicine, etc., and achieve the effects of reducing the probability of pollution, facilitating the production of preparations, and shortening the process flow

Inactive Publication Date: 2011-12-14
WUHAN HUST LIFE SCI & TECH
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Problems solved by technology

[0011] Once the bacterial endotoxin enters the drug, it is usually removed by strong heat, strong alkali, and strong acid treatment. Hexethyl starch cannot withstand such harsh conditions in the refining process. These methods are not suitable for the production of hydroxyethyl starch raw materials , such as strong heat will exceed 170 ℃ to effectively remove endotoxin, under this condition hydroxyethyl starch will produce carbonization; strong acid or strong alkali treatment will lead to the generation of by-products

Method used

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  • A clean production method of medium molecular weight hydroxyethyl starch

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Experimental program
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Effect test

Embodiment 1

[0057] 100Kg of 15% crude product solution containing hydroxyethyl starch 130 / 0.4 is processed by a hollow fiber ultra-micro-membrane composed of 304-type pipeline valves. The time is 5.5h, and the net wind is spray-dried, and the final product is 70Kg.

[0058] The resulting product is lower than the bacterial endotoxin limit value 1.25EU / g, and the product solution (5%) is transparent and colorless, reaching the Chinese Pharmacopoeia 2010 edition No. 1 turbidity liquid standard, and the absorbance at 400nm is 0.012, which is better than the national drug quality standard (bacterial endotoxin Toxin limit 5EU / g, No. 1 turbidity solution, absorbance at 400nm 0.05). Other indicators are in line with pharmaceutical standards.

Embodiment 2

[0060] The 20% crude product solution containing 100Kg hydroxyethyl starch 200 / 0.5 is decolorized by medicinal charcoal, kept at 80°C, then filtered through a 0.8 micron microporous filter element, and then passed through a ceramic membrane ultrafiltration membrane composed of 304 stainless steel pipe valves Treatment, the solvent added during the treatment is purified water (endotoxin limit 2.5EU / ml), so far, the treatment time is 4.5h, spray-dried with clean air, and the final product is 73Kg. The above process was repeated twice, and the equipment was cleaned and sterilized on-line before each implementation, and 85Kg and 66Kg of final products were obtained respectively.

[0061] The obtained three batches of final products are lower than the bacterial endotoxin limit of 2.5EU / g, and the product solution (5%) is transparent and light in color, reaching the standard of No. 2 turbidity liquid in the 2010 edition of the Chinese Pharmacopoeia, and the absorbance at 400nm is 0.0...

Embodiment 3

[0063] The 20% crude product solution containing 100Kg hydroxyethyl starch 200 / 0.5 is decolorized by medicinal charcoal, kept at 80°C, filtered through a 0.8 micron microporous filter element, and then treated by a ceramic ultrafiltration membrane composed of 304 stainless steel pipe valves At the same time, a 0.45-micron microporous filter element filtration system is connected in parallel. The solvent added in the process is water for injection (endotoxin limit 1.25EU / ml). So far, the treatment time is 4.5h, and the net air spray is dried, and the final product is 73Kg.

[0064] The final product is lower than the bacterial endotoxin limit of 1.25EU / g, and the product solution (5%) is transparent and light in color, reaching the standard of No. 1 turbidity liquid in the Chinese Pharmacopoeia 2010 edition, and the absorbance at 400nm is 0.010, reaching the national drug quality standard (bacterial endotoxin The limit value is 8EU / g, No. 2 turbidity solution, the absorbance at ...

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Abstract

The invention provides a clean production method of medium molecular weight hydroxyethyl starch, in particular to a clean production method in the refining process of chemical raw materials hydroxyethyl starch 200 / 0.5 and hydroxyethyl starch 130 / 04 used for plasma expanders. Bacterial endotoxin is the key toxic substance leading to clinical infusion pyrogenic reaction. The bacterial endotoxin in the raw material drug of hydroxyethyl starch exceeds the limit, which can easily lead to the limit of bacterial endotoxin in the final product of the preparation, hydroxyethyl starch injection, and the unqualified rate increases. The method of the invention is controlled by necessary process conditions such as clean air spray drying under clean conditions, microbial control under high temperature conditions, and on-line cleaning and disinfection of equipment, so that the quality of the bacterial endotoxin index of the obtained final product is obviously better than the current national drug quality standards. At the same time, it provides the necessary conditions for the direct preparation method of raw materials without microfiltration, which is helpful for the qualification of the insoluble particle index of the preparation, shortens the process flow of the final preparation, and reduces the probability of pollution.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and in particular relates to a production method of medium molecular weight hydroxyethyl starch. Background technique [0002] The main physiological functions of plasma volume expanders are to maintain normal plasma colloid osmotic pressure and expand plasma volume, improve hemodynamics, microcirculatory blood flow, hemorheology, oxygen supply and organ function. It is used for the treatment of shock caused by massive bleeding, burns or other trauma. An ideal plasma volume expander, which can quickly replenish lost blood volume, restore hemodynamic balance, restore normal microcirculatory blood flow, improve blood rheology, improve oxygen supply and organ function, and have a long enough residence time in blood vessels And good tolerance, and easy to be metabolized and excreted in the body. [0003] At present, the commonly used plasma volume expanders at home and abroad include h...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B31/12
Inventor 杨祥良阮健周小顺万江陵李进贺容丽王芳朱吉胜鲁珍娥岳蓉黄邦红
Owner WUHAN HUST LIFE SCI & TECH
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