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Pharmaceutical composition of tranexamic acid

A technology of tranexamic acid and its composition, which is applied in the field of medicine and can solve the problems of low medical quality

Active Publication Date: 2013-11-27
乐信乐美(海南)生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is currently no evidence from high-quality studies to support the use of antifibrinolytics in postpartum hemorrhage due to the methodological quality of the three included randomized trials.

Method used

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  • Pharmaceutical composition of tranexamic acid
  • Pharmaceutical composition of tranexamic acid
  • Pharmaceutical composition of tranexamic acid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0106] Tranexamic acid 200g, citric acid 13.6g, L-glutamic acid 1.36g, water for injection 2000mL.

[0107]Preparation method: Take 1500mL of water for injection, heat to 60°C, add 5g of citric acid, dissolve completely, add tranexamic acid, dissolve completely, add the remaining organic acid, add moistened 0.1% (g / ml) activated carbon for needles , stir evenly, heat-preserve and absorb for 30 minutes, decarbonize and filter through a 0.45 μm microporous membrane while it is hot, and filter it to a dilute tank, take a small amount of water for injection to wash the carbon. Add water for injection to nearly the prescribed amount. Fine filter with 0.22μm microporous membrane, fill with nitrogen and seal in ampoules sterilized at ≥300℃ for ≥5 minutes. Sterilize at 115°C for 30 minutes, pack and obtain 1000 injections.

Embodiment 2

[0109] Tranexamic acid 200g, citric acid 11.5g, L-glutamic acid 3.5g, water for injection 2000mL.

[0110] Preparation method: Take 1500mL of water for injection, heat to 60°C, add 5g of citric acid, dissolve completely, add tranexamic acid, dissolve completely, add the remaining organic acid, add moistened 0.1% (g / ml) activated carbon for needles , stir evenly, heat-preserve and absorb for 30 minutes, decarbonize and filter through a 0.45 μm microporous membrane while it is hot, and filter it to a dilute tank, take a small amount of water for injection to wash the carbon. Add water for injection to nearly the prescribed amount. Fine filter with 0.22μm microporous membrane, fill with nitrogen and seal in ampoules sterilized at ≥300℃ for ≥5 minutes. Sterilize at 115°C for 30 minutes, pack and obtain 1000 injections.

Embodiment 3

[0112] Tranexamic acid 250g, citric acid 14.4g, L-glutamic acid 4.4g, water for injection 5000mL.

[0113] Preparation method: Take 1875mL of water for injection, heat to 60°C, add 6.25g of citric acid, dissolve completely, add tranexamic acid, dissolve completely, add the remaining organic acid, add moistened 0.1% (g / ml) for needle use Activated carbon, stir evenly, heat-preserve and adsorb for 30 minutes, decarbonize and filter through a 0.45 μm microporous membrane while it is hot, and filter it to a dilute tank, take a small amount of water for injection to wash the carbon. Add water for injection to nearly the prescribed amount. Fine filter with 0.22μm microporous membrane, fill with nitrogen and seal in ampoules sterilized at ≥300℃ for ≥5 minutes. Sterilize at 115°C for 30 minutes, pack and obtain 1000 injections.

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Abstract

The invention belongs to the technical field of medicines, discloses a pharmaceutical composition of tranexamic acid, and particularly relates to a pharmaceutical composition containing tranexamic acid and organic acid. The pharmaceutical composition can be prepared into injection; the high-temperature and high-light tests show that the impurities, namely, cycloolefin, aminomethylbenzoic acid and a Z-isomer, and the total impurities of the injection meet the quality requirements. A preparation prepared from the pharmaceutical composition has the advantages of high stability and low impurity content.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition containing tranexamic acid as an active ingredient. Background technique [0002] Tranexamic acid, its chemical name is: trans-4-(aminomethyl) cyclohexanecarboxylic acid, structural formula: [0003] [0004] Molecular formula: C 8 h 15 NO 2 [0005] Molecular weight: 157.21 [0006] Tranexamic acid can strongly adsorb to the lysine binding site (LBS) of the fibrin affinity site on plasmin and plasminogen, inhibiting the binding of plasmin, plasminogen and fibrin, thereby It strongly inhibits the fibrinolysis caused by plasmin; in addition, in the presence of anti-plasmin such as macroglobulin in serum, the anti-fibrinolytic effect of tranexamic acid is more obvious. [0007] Tranexamic acid preparations are mainly used clinically for: 1. Trauma. Studies have shown that tranexamic acid can safely and reliably reduce the mortality...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/195A61K47/18A61K47/12A61P7/04
Inventor 吴静
Owner 乐信乐美(海南)生物科技有限公司
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