Tirapazamine parenteral hydrous preparation and preparation method thereof
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A technology for tirapazamine and water preparations, which is applied in the directions of pharmaceutical formulas, drug combinations, active ingredients of heterocyclic compounds, etc., and can solve problems such as easy precipitation of tirapazamine
Active Publication Date: 2015-04-01
HANGZHOU MINSHENG PHARM CO LTD
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[0018] The purpose of the present invention is to find a more stable parenteral aqueous preparation of tirapazamine, to solve the problem that tirapazamine is easily separated out in the prior art solution, enhance the stability and safety of the preparation, and meet the requirements of Clinical and general patient demand for the drug
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Embodiment 1
[0057] A: Tirapazamine 0.712g
[0058] B: Sodium acetate 41g
[0059] C: 160ml glacial acetic acid
[0060] Dissolve B and C in about 500ml of water, raise the temperature appropriately to keep the solution temperature at about 60°C, slowly add A and stir to dissolve completely, cool to room temperature, add appropriate amount of water to 1000ml, the pH is about 2.5 . Fill and seal in 20ml ampoules, seal and pack.
[0066] Take about 500ml of water to dissolve B and C, raise the temperature appropriately to keep the solution temperature at about 50°C, slowly add A and stir to dissolve completely, after cooling to room temperature, add sodium chloride and other osmotic pressure regulators, add appropriate amount of water to 1000ml , pH is about 6.0.
[0072] Dissolve B and C in about 500 ml of water, raise the temperature appropriately to keep the solution temperature at about 55°C, slowly add A and stir to dissolve completely, cool to room temperature, add appropriate amount of water to 1000 ml, and the pH is about 6.0. Fill and seal in 20ml ampoules, seal and pack.
[0073] Preparation use: intravenous injection
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Abstract
The invention provides a Tirapazamine parenteral hydrous preparation and a preparation method thereof. The preparation comprises a buffer solution of organic acid salts except for citrates and lactates, or a buffer solution of inorganic acid salts, or a buffer solution composed of inorganic acid salts and organic acids, and Tirapazamine or available salts thereof, wherein the concentration of thebuffer solution is 1-500 mmol / l, and the buffer solution is acceptable in medical preparations; the concentration of the Tirapazamine or available salts thereof is 0.01-4 mmol / l; and the pH value ofthe preparation is 2.0-7.0. The invention solves the problem of easy precipitation when the solution of Tirapazamine is put still in the prior art, enhances the stability and the safety of the preparation and meets the clinical and broad patients' requirements for the preparation.
Description
technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a tirapazamine parenteral aqueous preparation and a preparation method thereof. Background technique [0002] Tirapazamine, English name tirapazamine or TPZ, chemical name: 3-amino-1,2,4-benzotriazine-1,4-dioxide (3-Amino-1,2,4-benzotuiazine-1, 4-dioxide), also known as Win59075 or SR4233, its chemical structure is as follows: [0003] [0004] (chemical structural formula of tirapazamine) [0005] Molecular formula: C 7 h 6 N 4 o 2 [0006] Molecular weight: 178 [0007] Tirapazamine is a novel bioreductive active substance. It can be reduced in hypoxic cells of tumor tissue to produce a metabolite with cytotoxic effect. The killing effect of this metabolite on hypoxic cells is significantly higher than that of its parent compound, causing the death of hypoxic cells in tumor tissue, and can significantly increase the anti-tumor effect ...
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