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Technical formula and preparation method of tranexamic acid freeze-dried powder injection

A freeze-dried powder injection and tranexamic acid technology, applied in the chemical field, can solve the problems of unqualified tranexamic acid product quality and potential safety hazards, and achieve the effects of uniform and stable quality, low production cost, and improved stability

Inactive Publication Date: 2015-11-18
SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Tranexamic acid is an ion-sensitive drug. The complexation of the Z-isomer in the drug solution with heavy metals will cause the injection to produce opalescence, and the injection preparation usually has metal ions in the production, which may easily affect the quality of the tranexamic acid product. Unqualified, bringing potential safety hazards to clinical practice

Method used

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  • Technical formula and preparation method of tranexamic acid freeze-dried powder injection
  • Technical formula and preparation method of tranexamic acid freeze-dried powder injection
  • Technical formula and preparation method of tranexamic acid freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] prescription

[0021]

[0022] Measure tert-butanol into a container, add water for injection, stir and mix evenly, cool the mixed solvent to 8°C and keep it warm, then add tranexamic acid, stir to mix the solution evenly, after the mixed solution is checked and passed, use The peristaltic pump is sent to the sterile room and filtered through a 0.22 μm microporous membrane until it is clear, filled in a controlled antibiotic glass bottle, partially plugged with a butyl rubber stopper, and placed in a plate; the plated sample to be freeze-dried is placed in a freeze-dried In the box, the temperature of the sample is lowered to -35°C and kept for 3h, the vacuum system is turned on, and when the vacuum of the front box reaches below 20Pa, the freeze-drying is started, and the temperature of the shelf is raised to -10°C within 1 hour, and kept for 5h, then Raise the temperature of the shelf to 0°C within 1 hour and maintain it for 4h, raise the temperature of the shelf t...

Embodiment 2

[0024] prescription

[0025]

[0026] Measure tert-butanol into a container, add water for injection, stir and mix evenly, cool the mixed solvent to 8°C and keep it warm, then add tranexamic acid, stir to mix the solution evenly, after the mixed solution is checked and passed, use The peristaltic pump is sent to the sterile room and filtered through a 0.22 μm microporous membrane until it is clear, filled in a controlled antibiotic glass bottle, partially plugged with a butyl rubber stopper, and placed in a plate; the plated sample to be freeze-dried is placed in a freeze-dried In the box, the temperature of the sample is lowered to -35°C and kept for 3h, the vacuum system is turned on, and when the vacuum of the front box reaches below 20Pa, the freeze-drying is started, and the temperature of the shelf is raised to -10°C within 1 hour, and kept for 5h, then Raise the temperature of the shelf to 0°C within 1 hour and maintain it for 4h, raise the temperature of the shelf t...

Embodiment 3

[0028] prescription

[0029]

[0030] Measure tert-butanol into a container, add water for injection, stir and mix evenly, cool the mixed solvent to 8°C and keep it warm, then add tranexamic acid, stir to mix the solution evenly, after the mixed solution is checked and passed, use The peristaltic pump is sent to the sterile room and filtered through a 0.22 μm microporous membrane until it is clear, filled in a controlled antibiotic glass bottle, partially plugged with a butyl rubber stopper, and placed in a plate; the plated sample to be freeze-dried is placed in a freeze-dried In the box, the temperature of the sample is lowered to -35°C and kept for 3h, the vacuum system is turned on, and when the vacuum of the front box reaches below 20Pa, the freeze-drying is started, and the temperature of the shelf is raised to -10°C within 1 hour, and kept for 5h, then Raise the temperature of the shelf to 0°C within 1 hour and maintain it for 4h, raise the temperature of the shelf t...

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Abstract

The invention discloses a technical formula and a preparation method of a tranexamic acid freeze-dried powder injection. The tranexamic acid freeze-dried powder injection comprises tranexamic acid; a mixed solvent comprising 5-30% of tertbutyl alcohol and the balance of injection water in percentage by volume is used in the preparation process, and the concentration of tranexamic acid in the mixed solvent is 30-150 mg / ml. The preparation process comprises the following steps: measuring tertbutyl alcohol, adding injection water, mixing uniformly, cooling to 2-10 DEG C, keeping the temperature, adding tranexamic acid, stirring to enable tranexamic acid to be dissolved, filtering, filling, adding plugs, placing the mixture into discs, freeze-drying, pressing the plugs, unboxing, sealing opening through a cover, and packaging after passing the quality inspection to obtain the tranexamic acid freeze-dried powder injection. The tranexamic acid freeze-dried powder injection can be used for treating bleeding caused by acute and chronic, local or systemic primary fibrinolysis hyperfunction, bleeding caused by visceral trauma or operations, fibrinolytic bleeding, menorrhagia and other diseases.

Description

technical field [0001] The invention relates to the field of chemistry, in particular to a technical formula and method for preparing tranexamic acid freeze-dried powder injection. Background technique [0002] Tranexamic acid is a synthetic amino acid antifibrinolytic drug, which can competitively inhibit the combination of lysine and plasmin in fibrin, thereby inhibiting the cracking of fibrin clots and producing hemostatic effect. It is mainly used clinically for fibrinolysis For all kinds of bleeding caused by hyperactivity, the bioavailability is 34%, and the half-life is 3.1h. [0003] Tranexamic acid is an ion-sensitive drug. The complexation of the Z-isomer in the drug solution with heavy metals will cause the injection to produce opalescence, and the injection preparation usually has metal ions in the production, which may easily affect the quality of the tranexamic acid product. Unqualified, bringing potential safety hazards to clinical practice. [0004] Therefo...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/195A61K47/10A61K47/26A61P7/04
Inventor 林虹贾文强黄伟棠
Owner SHENZHEN FONCOO PHARMACEUTICAL CO LTD
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