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Hydroxyethyl starch injection liquid and preparation method thereof

A technology of hydroxyethyl starch and injection, which is applied in blood diseases, medical formulas, extracellular fluid diseases, etc., can solve problems such as hyperchloric metabolic acidosis, achieve small damage, solve blood source tension, reduce The effect of the required amount

Inactive Publication Date: 2007-07-11
李晓祥
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN1235833A, CN1195527A announced the injection of hydroxyethyl starch, which is composed of hydroxyethyl starch and sodium chloride, but when it is used, it has the disadvantage of easily causing hyperchloric metabolic acidosis

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Take 6Kg of hydroxyethyl starch (200 / 0.5), add an appropriate amount of water for injection, heat to dissolve the hydroxyethyl starch, let it cool (below 50°C), add 672g of sodium chloride, 317g of sodium lactate, 99g of glucose, and calcium chloride in sequence 37g, potassium chloride 22g, magnesium chloride 9g, stir to dissolve, add water for injection to 100L, adjust the pH value to 5-7, add 0.05% activated carbon and stir for 30 minutes, fine filter, check the content and pH value after passing, divide Put it into a 500ml hard glass bottle, press the cap, and sterilize. This product is a clear, light yellow to amber solution. According to the preliminary stability study, it is stable to heat, and it should be stored away from strong light.

Embodiment 2

[0026]Take 6Kg of hydroxyethyl starch (200 / 0.5), add an appropriate amount of water for injection, heat to dissolve the hydroxyethyl starch, let it cool (below 50°C), add 605g of sodium chloride, 285g of sodium lactate, 50g of glucose, and calcium chloride in sequence 33g, potassium chloride 20g, magnesium chloride 8.1g, stir to dissolve, add water for injection to 100L, adjust the pH value to 5-7, add 0.05% activated carbon and stir for 30 minutes, fine filter, check the content and pH value after passing, Dispensed into 500ml hard glass bottles, capped and sterilized. This product is a clear, light yellow to amber solution. Storage needs to avoid strong light exposure.

Embodiment 3

[0028] Take 6Kg of hydroxyethyl starch (200 / 0.5), add an appropriate amount of water for injection, heat to dissolve the hydroxyethyl starch, let it cool (below 50°C), add 740g of sodium chloride, 345g of sodium lactate, 100g of glucose, and calcium chloride in sequence 40g, potassium chloride 24g, magnesium chloride 10g, stir to dissolve, add water for injection to 100L, adjust the pH value to 5-7, add 0.05% activated carbon and stir for 30 minutes, fine filter, check the content and pH value after passing, divide Put it into a 500ml hard glass bottle, press the cap, and sterilize. Storage needs to avoid strong light exposure.

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Abstract

The invention provides a hydroxyethyl starch injection used as plasma substitute, process for preparation and method of application, compared with the existing hydroxyethyl starch injections, higher safety and effectiveness can be achieved in clinical application, the injury to kidney function is lowered, thereby causing no high chlorine metabolic acidosis.

Description

technical field [0001] The invention relates to a hydroxyethyl starch injection used as a plasma substitute and a preparation method and application thereof, in particular to a hydroxyethyl starch (200 / 0.5) injection. It belongs to the field of medicine. Background technique [0002] Hydroxyethyl starch is the third generation of artificial colloid, which is made from high molecular weight amylopectin after degradation, hydroxyethylation and further processing. Divided by molecular weight, there are low molecular weight hydroxyethyl starch (Mw40000~7000D), medium molecular weight hydroxyethyl starch (Mw1300000~2000000D) and high molecular weight hydroxyethyl starch (Mw4500000~4800000D). According to the degree of substitution, there are low-substituted hydroxyethyl starches (Ms0.3-0.5) and high-substituted hydroxyethyl starches (Ms0.6-0.7). Clinically, it is widely used as an artificial plasma substitute. [0003] CN1650885A discloses a kind of hydroxyethyl starch for inj...

Claims

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Application Information

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IPC IPC(8): A61K31/718A61K33/00A61P7/08A61K31/7004A61K31/191
Inventor 李德刚徐自奥徐玉梅
Owner 李晓祥
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