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Tranexamic acid freeze-dried powder injection and preparation method thereof

A technology for freeze-dried powder injection and tranexamic acid, which is applied in freeze-dried delivery, powder delivery, blood diseases, etc., can solve the problems of inconvenient transportation and storage, reduce the amount of patient infusion, and damage liquid preparations, and ensure chemical stability. performance, resolving cross-contamination opportunities, and ease of transportation

Inactive Publication Date: 2010-06-23
胥祥进
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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 require reducing the amount of fluid infusion, but water injection cannot solve the problem
3. In the cold season, especially in the north and alpine areas, there are inconveniences in transportation and storage
4. The liquid preparation is damaged, which will easily cause pollution to the packaging; 5. The application range is narrow

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]

[0016] Prepare 1000 sticks

[0017] (2) Preparation process

[0018] 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.

[0019] ②Put the filled vials into a pre-freeze dryer, freeze to -45°C and keep war...

Embodiment 2

[0021] (1) Preparation prescription:

[0022] Tranexamic acid 250g

[0023] Glucose 50g

[0024] Add water for injection to 2000ml

[0025]

[0026] Prepare 1000 sticks

[0027] (2) preparation process: with embodiment 1

Embodiment 3

[0029] (1) Preparation prescription:

[0030] Tranexamic acid 250g

[0031] Dextran 50g

[0032] Add water for injection to 2000ml

[0033]

[0034] Prepare 1000 sticks

[0035] (2) preparation process: with embodiment 1

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PUM

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Abstract

The invention discloses a tranexamic acid freeze-dried powder injection and a preparation method thereof, comprising the following components in parts by weight: 0.05-10 parts of tranexamic acid, 1-100 parts of freeze-dried powder proppant, and a proper mount of pH regulator. The invention belongs to hemostasis curative, is a freeze-dried powder injection, has stable performance to light, heat, oxygen, water and the like, and has no pollution as well as convenient operation, transportation and storage. The tranexamic acid freeze-dried powder injection is suitable for various haemorrhages caused by acute, chronic, local, systemic and primary fibrinolysis, trauma or operation haemorrhages of organs rich in plasminogen activators, such as prostate and the like and is used as an antagonist of tectotype plasminogen activators (t-PA), streptokinase and urokinase. The tranexamic acid freeze-dried powder injection is also suitable for thrombolytic haemorrhage caused by abortion and amniotic fluid embolism, is used for preventing or lightening haemorrhage of a haemophile after exelcymosis or oral cavity operation, haemorrhage caused by light diseases of nervous centralis pathological changes, and is used for treating hereditary angioneuroticedema and active hemorrhage of haemophile.

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): A61K9/19A61K31/195A61P7/04
Inventor 胥祥进
Owner 胥祥进
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