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

A technology of tranexamic acid and freeze-dried powder injection, which is applied in the direction of freeze-drying transportation, making medicines into special physical or ingestible devices, powder transportation, etc., which can solve the problems of low product output, increased filling volume, Reduced output and other issues, to achieve the effect of reduced transportation costs, reduced packaging volume, and increased output

Active Publication Date: 2015-12-16
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The preparation method of 0.25g small-volume tranexamic acid freeze-dried powder injection:

[0032] The formula is as follows, making 1000 sticks:

[0033] Tranexamic acid 250g

[0034] Polyethylene glycol 400 40g

[0035] Water for injection 2150ml

[0036] Add water for injection to cool down to 27±1°C, then add tranexamic acid, and keep the temperature of the feed liquid at 27±1°C. After the material liquid is dissolved, weigh the prescribed amount of PEG400 and add it, stir until dissolved, take a sample to detect the pH value of the material liquid is 7.0±0.5 (required to be controlled between 6.0 and 7.5), add 0.1% (W / V) activated carbon for decolorization 30 minutes.

[0037] Turn on the second Grundfos pump and use a titanium rod filter for decarburization and filtration, pass the feed liquid through the second sterilizing filter element to sterilize, and transport it to the aseptic insulation liquid storage tank for storage. After sterilizing and filterin...

Embodiment 2

[0041] The preparation method of 0.5g small-volume tranexamic acid freeze-dried powder injection:

[0042] The formula is as follows, making 1000 sticks:

[0043] Tranexamic acid 500g

[0044] Polyethylene glycol 40080g

[0045] Water for injection 3600ml

[0046] Add water for injection to cool down to 25°C to 30°C, then add tranexamic acid, and keep the temperature of the feed liquid between 25°C and 30°C. After the material liquid is dissolved, weigh the prescribed amount of PEG400 and add it, stir until dissolved, take a sample to detect the pH value of the material liquid is 7.0±0.5 (required to be controlled between 6.0 and 7.5), add 0.1% (W / V) activated carbon for decolorization 30 minutes.

[0047] Turn on the second Grundfos pump and use a titanium rod filter for decarburization and filtration, pass the feed liquid through the second sterilizing filter element to sterilize, and transport it to the aseptic insulation liquid storage tank for storage. After steriliz...

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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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/195A61J3/02A61P7/04
Inventor 何茂群苗得足张光明白先杰司吉晖张国明
Owner REYOUNG PHARMA
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