Small volume tranexamic acid freeze-dried powder injection, its preparation method and its production device

Abstract

The invention belongs to the technical field of freeze-dried powder injection preparation, and relates to a small-size tranexamic acid freeze-dried powder injection, a preparation method and a production device thereof. The small-size tranexamic acid freeze-dried powder injection contains tranexamic acid freeze-dried powder filled in a 7-ml tubular penicillin bottle; the tranexamic acid content in the tranexamic acid freeze-dried powder injection is 0.1 g or 0.2 g; the preparation method comprises the following steps: adding injection water into tranexamic acid and auxiliary materials with prescription amounts, cooling to 28-30 DEG C to prepare a concentrated solution, adding active carbon, uniformly stirring, performing decarburization and filtration by a titanium rod, then performing fine filtration; adding the remaining injection water with a preparation amount and a temperature of 28-30 DEG C into a solution preparation tank, filtering by the titanium rod, then performing fine filtration; mixing the obtained filtrates to prepare a diluted preparation solution, performing heat preservation at 28-30 DEG C, filling the solution into a 7-ml tubular penicillin bottle, performing freeze-drying, tamping, and cover rolling to obtain the product. According to the invention, the package size of the tranexamic acid freeze-dried powder injection is reduced; thus the yield is effectively increased; the energy consumption is reduced; the packaging and transport cost is reduced; and the freeze-drying and evaporation energy consumption is greatly reduced.

Description

technical field [0001] The invention belongs to the technical field of preparation of freeze-dried powder injections, and relates to a small-volume tranexamic acid freeze-dried powder injection, a preparation method and a production device thereof. Background technique [0002] Currently commercially available 0.25g tranexamic acid freeze-dried powder injections and 0.5g tranexamic acid freeze-dried powder injections are all filled with 10ml molded vials. The volume occupied by each bottle is large, resulting in the low yield of each batch of products, because the water solubility of tranexamic acid itself is not good, so it needs to be dissolved in a large amount of solvent in the preparation process, so as to make Tranexamic acid freeze-dried powder for injection. The original preparation process has no temperature control, and the temperature is generally between 20°C and 25°C during concentrated preparation. Therefore, it is necessary to add 50 times the water of the ma...

AI Technical Summary

Problems solved by technology

[0002] Currently commercially available 0.25g tranexamic acid freeze-dried powder injections and 0.5g tranexamic acid freeze-dried powder injections are all filled with 10ml molded vials. The volume occupied by each bottle is large, resulting in the low yield of each batch of products, because the water solubility of tranexamic acid itself is not good, so it needs to be dissolved in a large amount of solvent in the preparation process, so as to make Tranexamic acid freeze-dried powder injection

The original preparation process has no temperature control, and the temperature is generally between 20°C and 25°C during concentrated preparation. Therefore, it is necessary to add 50 times the water of the main ingredient to dissolve it, thereby increasing the filling volume. In order to ensure the freeze-drying process The sublimation speed of water is filled with 10ml molded vials, resulting in a decrease in the output of each batch, an increase in energy consumption for freeze-drying containing more water, and an increase in packaging and transportation costs

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