Method for preparing donkey-hide gelatin plasma substitute injection

Abstract

The invention relates to a method for preparing a donkey-hide gelatin plasma substitute injection. According to the method, degradation terminal points of donkey-hide gelatin can be controlled through monitoring relative viscosity of a donkey-hide gelatin solution to ensure polypeptide molecular weight and reasonable molecular weight distribution after the donkey-hide gelatin solution is degraded, so as to enable osmotic pressure of the prepared donkey-hide gelatin plasma substitute injection to be close to that of human plasma, and a relatively good capacity expansion effect is realized in clinic practice; succinic anhydride is used for performing acylation modification on the degraded donkey-hide gelatin solution, a polypeptide chain of the modified donkey-hide gelatin solution is relatively stable, so that the polypeptide molecular weight and the molecular weight distribution are effectively controlled, and the safety and the availability of a product are improved; in a process of preparing plasma substitutes, an appropriate amount of electrolytes such as sodium chloride, potassium chloride and calcium chloride are added so as to ensure that when the donkey-hide gelatin plasma substitutes are injected in quantity, electrolyte disturbance can be avoided; under different PH value conditions, through double adsorption of diatomite and activated carbon, heat sources, impurities and colors can be sufficiently removed, so that adverse reactions in clinical use can be avoided.

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals, and relates to a method for preparing donkey skin gelatin-substituted plasma injection by using donkey skin gelatin as a raw material. Background technique [0002] As we all know, blood is a very precious and limited resource, but in medical treatment, the application of blood products is very extensive and necessary. Therefore, with the development of medical technology, more plasma substitutes (referred to as "plasma substitute") have also been developed, and replace blood products to supplement blood volume when the patient's physical condition permits. It is understood that up to now, more than 30 types of plasma substitutes have been studied at home and abroad, but few are actually used in clinical practice, mainly including dextran, hydroxyethyl starch and modified gelatin. There are many adverse reactions in the clinical application of dextran, such as allergic reactions, acute renal fa...

AI Technical Summary

Problems solved by technology

These methods are to directly prepare plasma substitute after hydrolyzing gelatin, without modifying gelatin, the stability of polypeptide chain after hydrolysis of gelatin cannot be guaranteed, the peptide chain is easy to break or the polymerization of free amino groups, making it difficult to effectively control the molecular weight and molecular weight distribution of gelatin polypeptide , thus affecting the safety and effectiveness of the product

In addition, only sodium chloride is added to the prepared plasma substitute, and other necessary electrolytes, such as calcium chloride and potassium chloride, are not added. Large-scale infusion can easily cause electrolyte disturbance.

Images