Asparaginase freeze-dried powder injection and preparation method thereof, as well as asparaginase solution

A technology of asparaginase and freeze-dried powder injection, which is applied in the direction of freeze-dried transportation, powder transportation, pharmaceutical formulations, etc., can solve the problems of uncertain pH value, unfavorable operation, and injection defects, etc., and achieves convenient clinical use and improved Safety, irritation-reducing effect
CN102138909AActive Publication Date: 2011-08-03CHANGZHOU QIANHONG BIOPHARMA
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Patent Information

Authority / Receiving Office
CN Β· China
Patent Type
Applications(China)
Current Assignee / Owner
CHANGZHOU QIANHONG BIOPHARMA
Publication Date
2011-08-03

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Abstract

The invention discloses an asparaginase freeze-dried powder injection. The injection comprises asparaginase, a buffering agent, a surfactant, medical auxiliary materials and 5% of injection water which is used as a solvent in a preparing process and less than the addition finally, wherein the surfactant is a nonionic surfactant; and the buffering agent and the nonionic surfactant are added into the formula, so that the situation that tiny visible particles exceed standard is prevented when the asparaginase is dissolved and transferred into an injection. The invention also discloses a dedicated solution for dissolving the asparaginase, wherein the solution solvent is the injection water, and the solute comprises the buffering agent and the surfactant. On the premise of not changing the conventional formula of the freeze-dried powder injection, when the freeze-dried powder is dissolved in the solution, and is transferred into sodium chloride or a glucose injection, the situation that tiny visible particles exceed standard is prevented, so that the stimulation to human bodies is reduced in use, and the clinical administration safety is improved.
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Description

technical field

[0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried powder injection of asparaginase and a preparation method thereof, and a solvent used for dissolving asparaginase. Background technique

[0002] Asparaginase (also known as L-asparaginase, asparaginase, asparaginase, etc.) is a drug that selectively inhibits tumor cells, especially for acute lymphoblastic leukemia (ALL) The curative effect is the best, and it also has a certain effect on acute myeloid leukemia, acute monocytic leukemia, and malignant lymphoma.

[0003] Asparaginase (hereinafter referred to as L-ASP) can hydrolyze asparagine in serum into aspartic acid and ammonia, and asparagine is an amino acid necessary for cell synthesis of protein and proliferation. Normal cells have their own synthesis gate However, tumor cells such as acute leukemia do not have this function; therefore, when L-ASP is used to rapidly lack asparagine, the tumor cells...

Claims

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