Etamsylate injection and preparation method thereof

Abstract

The invention belongs to the technical field of medicine preparation, and particularly relates to an etamsylate injection and a preparation method thereof. The preparation method comprises the following steps: (1) preparing a saturated solution of etamsylate, edetate disodium, sodium pyrosulfite and sodium chloride for standby use; and dissolving mannitol, potassium chloride and calcium chloride in 10ml of water for injection to obtain a trace element solution for later use; (2) uniformly mixing the saturated solution of etamsylate, edetate disodium, sodium pyrosulfite and sodium chloride withthe trace element solution to obtain a concentrated raw material solution; (3) putting the concentrated raw material solution into a concentrated mixing tank, adsorbing, and filtering until the concentrated solution is clear; (4) putting the concentrated solution into a diluting tank, adding water for injection, adsorbing, and filtering to obtain a diluted solution; (5) carrying out three-stage filtration treatment on the diluted solution to obtain a finished stock solution; (6) supplementing water for injection into the finished stock solution until the weight of the final solution is reached; (7) sealing; (8) sterilizing for 10 minutes; (9) detecting whether visible suspending foreign matters and particles exist in sterilized ampoule bottles or not; and (10) storing.

Description

technical field [0001] The application belongs to the technical field of medicine preparation, and in particular relates to a phensulfame injection and a preparation method thereof. Background technique [0002] Etamsulfame Injection is a colorless or almost colorless clear liquid. It is used to prevent and treat bleeding before and after various operations, and it can also be used for bleeding caused by platelet dysfunction and increased vascular fragility. It has a wide range of uses. [0003] However, after several months of storage of the fensulfame injection, the phenomenon of pH instability will occur, resulting in the appearance of flocs in the product, which in turn leads to the failure of visible foreign matter. Due to the existence of this phenomenon, users may return goods, and these returned goods need to be scrapped. This not only causes a lot of waste, but also has adverse effects on customers, and the reputation of manufacturers has been questioned. Conten...

AI Technical Summary

Problems solved by technology

[0003] However, after several months of storage, the pH of Etamsulfame Injection will be unstable, resulting in the appearance of flocs in the product, which will lead to the failure of visible foreign matter

Due to the existence of this phenomenon, users will return products, and these returns need to be scrapped.

This not only causes a lot of waste, but also has a negative impact on customers, and the reputation of the manufacturer has been questioned

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