Freeze-dried tranexamine powder injection and its preparing prcess

A technology of freeze-dried powder injection and tranexamic acid, which is applied in blood diseases, extracellular fluid diseases, peptide/protein components, etc. It can solve the problems of inconvenient transportation and storage, reduce the amount of infusion for patients, and repeatedly pump liquids, etc. , to achieve the effect of being suitable for large-scale production, solving the chance of cross-contamination, and reducing volume and weight

Inactive Publication Date: 2003-01-15
于航
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the preparation of this product is a water injection, and there are many inconveniences in the process of use: 1. In actual operation, the liquid needs to be pumped many times, and the preparation is easily contaminated by bacteria, resulting in unqualified heat source
2. In actual clinical practice, many diseases req

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] (1) Preparation prescription:

[0012] Tranexamic acid 250g

[0013] Mannitol 50g

[0014] Add water for injection to 2000ml

[0015] Prepare 1000 sticks

[0016] (2) Preparation process

[0017] ① Add 1200ml of water for injection to the prescribed amount of tranexamic acid, heat and stir to dissolve it, add 0.1% activated carbon for injection, stir at 80°C for 15 minutes, filter, and set aside. Take the prescribed amount of mannitol, add 400ml of water for injection, heat, stir, and dissolve, add 0.1% activated carbon for injection, stir at 80°C for 15 minutes, filter, and set aside. Mix the above two liquids, adjust the pH to 6.0-7.5, add water for injection to 2000ml, filter and sterilize with a 0.2um microporous membrane under aseptic conditions, after measuring the content, fill it in 2ml / bottle 10ml control glass bottle.

[0018] ②Put the filled vials into a pre-freeze dryer, freeze to -45°C and keep warm for 2 hours, vacuumize, and heat up at a...

Embodiment 2

[0020] (1) Preparation prescription:

[0021] Tranexamic acid 250g

[0022] Glucose 50g

[0023] Add water for injection to 2000ml

[0024] Prepare 1000 sticks

[0025] (2) preparation process: with embodiment 1

Embodiment 3

[0027] (1) Preparation prescription:

[0028] Tranexamic acid 250g

[0029] Dextran 50g

[0030] Add water for injection to 2000ml

[0031] Prepare 1000 sticks

[0032] (2) preparation process: with embodiment 1

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PUM

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Abstract

A freeze dried tranexamine acid powder used as antihemorrhagic injection for treating various hemorrhagic diseases contains tranexamine acid (0.05-10 wt. portions), freeze drying supporting agent (0-100) and pH regulator.

Description

Technical field: [0001] The invention belongs to hemostatic medicine, in particular to a tranexamic acid freeze-dried powder injection, and also relates to a preparation method of the injection. Background technique: [0002] The present invention is mainly used for treating various hemorrhages caused by acute or chronic, localized or generalized hyperfibrinolysis, such as bleeding in oral cavity, surgical operation, trauma, obstetrics and gynecology, and gastrointestinal tract. At present, the preparation of this product is a water injection, and there are many inconveniences in the process of use: 1. The liquid needs to be pumped many times in the actual operation, and the preparation is easily contaminated by bacteria, resulting in unqualified heat source. 2. In actual clinical practice, many diseases require reducing the amount of fluid infusion, but water acupuncture cannot solve the problem. 3. In the cold season, especially in the north and alpine regions, there are ...

Claims

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Application Information

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IPC IPC(8): A61K31/195A61P7/04
Inventor 于航
Owner 于航
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