Preparation method for improving quality of medium molecular weight hydroxyethyl starch

Abstract

The invention provides a new process for preparing medium molecular weight hydroxyethyl starch materials. In the ultrafiltration step of the production process flow, a filter membrane with the molecular mass cut-off of 300,000 and a filter membrane with the molecular mass cut-off of 100,000 are used in turn for ultrafiltration, and an ultrafiltration process of only using a filter membrane with the molecular mass cut-off of 100,000 is replaced, so that the content of endotoxin in the hydroxyethyl starch is effectively reduced, the molecular weight of the hydroxyethyl starch is more concentrated in a medium molecular weight range, the safety and quality of the product are improved, and the produced medium molecular weight hydroxyethyl starch (including hydroxyethyl starch 130 / 0.4 and hydroxyethyl starch 200 / 0.5) materials and preparations meet the standard of state pharmacopoeia.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a preparation method for improving the quality of medium molecular weight hydroxyethyl starch medicine. Background technique [0002] Hydroxyethyl starch is produced from corn amylopectin through hydroxyethylation and hydrolysis reaction. After adding a certain concentration of normal saline to hydroxyethyl starch, it can be made into hydroxyethyl starch sodium chloride injection. This pharmaceutical preparation Clinically, it has the effects of expanding blood volume, acute isovolemic hemodilution, and improving microcirculation. It can replace human plasma for trauma, burns, surgery, shock, and emergency treatment of critical illness. It is widely used in hospitals and health centers. Taste. According to its molecular weight, hydroxyethyl starch is divided into: low molecular weight hydroxyethyl starch (such as: hydroxyethyl starch 20 / 0.8, hydroxyethyl starch 40 / 0.8), medium molecular we...

AI Technical Summary

Problems solved by technology

There are some defects in this process: because cornstarch will be contaminated with a large number of bacteria during production, storage and transportation, these bacteria will all die after processing steps such as heating and etherification in the production process, bacteria (mainly Gram-negative Bacteria) after death, the bacterium is lysed, the outer membrane of its cell wall falls off, and is decomposed into lipopolysaccharide (LPS) and lipid A, also known as endotoxin, which is the active part of the pyrogen, and their relative molecular mass is generally 10,000~ 25,000 KD, forming associations in aqueous solution, the relative molecular mass can reach 500,000 to 1 million KD

In the production of medium molecular weight hydroxyethyl starch, if ultrafiltration is carried out according to the currently used 100,000 Dalton hollow fiber membrane filter, only endotoxins with a molecular weight below 100,000 Daltons can be filtered out, while those with a molecular weight of 100,000 Daltons Endotoxin associations above Daltons cannot be filtered out, and the produced hydroxyethyl starch raw materials will contain more endotoxin associations, and then add a certain concentration of normal saline to make hydroxyethyl starch sodium chloride After the injection of pharmaceutical preparations, it will bring safety hazards to clinical use, and even cause medical accidents

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