Recombinant human prourokinase preparation for injection as well as preparation method and application thereof

Abstract

The invention relates to a recombinant human pro-urokinase preparation for injection as well as a preparation method and application thereof, the recombinant human pro-urokinase preparation for injection is a liquid preparation, the formula of the recombinant human pro-urokinase preparation comprises recombinant human pro-urokinase, a protective agent, a surfactant and buffer salt, and a solvent is water for injection. According to the recombinant human pro-urokinase preparation for injection, the protective agent and the surfactant are used in a combined mode and jointly serve as the protective agent of the recombinant human pro-urokinase, so that the structure of the recombinant human pro-urokinase is more stable, and the recombinant human pro-urokinase is not prone to degradation. The invention further provides a combined suite containing the recombinant human prourokinase freeze-drying preparation for injection, the combined suite comprises the recombinant human prourokinase freeze-drying preparation for injection, normal saline, a quick connection communicating vessel and an injector which are independently packaged, and compared with the prior art, the combined suite has the advantages that the working efficiency of medical staff can be improved, the compliance is improved, the rescue time can be saved, and the safety of medical staff is improved. And the use experience of medical staff is improved, and good practicability and practical significance are achieved.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, in particular to a recombinant human urokinase original preparation for injection and a preparation method and application thereof, in particular to a recombinant human urokinase original liquid preparation for injection and a preparation method thereof, and a recombinant human urokinase preparation for injection Freeze-dried preparation of human pro-urokinase, preparation method thereof, and combination kit comprising freeze-dried preparation of recombinant human pro-urokinase for injection. Background technique [0002] Prourokinase (pro-UK) is a serine protease that can activate plasminogen in the body and convert it into active plasmin, thereby dissolving fibrin in thrombus. Wide range of applications. [0003] The peptide bond between Lys158-Ile159 in pro-UK is easily hydrolyzed by plasmin and some other enzymes to generate urokinase (UK). UK consists of two peptide chains, A chain and...

AI Technical Summary

Problems solved by technology

However, there is a certain amount of human serum albumin in this preparation as a product protection agent, and the raw material is relatively special. There are three restrictive factors. First, it comes from human blood, which has virus safety risks; The big problem is that the supply in the market is often in short supply, which brings certain procurement risks; the third is that protein aggregation, deamidation, non-enzymatic browning, oxidation reaction and hydrolysis occur during storage, which exist in the prescription There is a contribution to the lower eutectic point of the finished product (low eutectic point makes the appearance of the product after lyophilization poor)

[0006] In addition, during the use of the freeze-dried powder injection in the prior art, medical personnel are required to use a 10mL syringe to draw physiological saline, then inject the liquid into the vial containing the powder injection, and gently overturn it 1-2 times to mix well. ; Repeat the above steps to extract 4 vials, mix them and inhale them, inhale them with a syringe for injection (intravenous injection is completed within 3 minutes), then take another 6 vials, dissolve them in 90mL of normal saline, shake and mix them well, and within 30min Intravenous infusion complete

The above treatment methods will greatly take up the precious rescue time of medical staff, and the work efficiency is low

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