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Tirapazamine parenteral hydrous preparation and preparation method thereof

A technology for tirapazamine and intestinal tract, which is applied in the field of tirapazamine parenteral administration aqueous preparations and its preparation, and can solve the problems such as easy precipitation of tirapazamine

Active Publication Date: 2012-09-05
HANGZHOU MINSHENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] The purpose of this patent invention is to find a more stable parenteral administration aqueous preparation of tirapazamine to solve the problem of easy precipitation of tirapazamine in the prior art, and to enhance the stability and safety of the preparation. To meet the needs of the clinical and the majority of patients for the drug

Method used

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  • Tirapazamine parenteral hydrous preparation and preparation method thereof
  • Tirapazamine parenteral hydrous preparation and preparation method thereof
  • Tirapazamine parenteral hydrous preparation and preparation method thereof

Examples

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Effect test

preparation example 1

[0036] a: tirapazamine 0.01 g

[0037] b: citric acid 0.0042 g

[0038] c: 0.001 g of sodium hydroxide

[0039] Take 300 ml of water to dissolve b and c. After complete dissolution, raise the temperature appropriately to keep the solution temperature at about 60°C, slowly add a, stir to dissolve it completely, cool to room temperature, add sodium chloride and other osmotic pressure regulators, add appropriate amount of water to 1000 ml, and the pH is about is 6.5.

[0040] Preparation administration method: intravenous infusion.

preparation example 2

[0042] a: Tirapazamine 0.16g

[0043] b: citric acid 0.0208g

[0044] c: 0.00594 grams of sodium hydroxide

[0045] Take 300 ml of water to dissolve b and c. After complete dissolution, raise the temperature appropriately to keep the solution temperature at about 50°C, slowly add a, stir to dissolve it completely, after cooling to room temperature, add sodium chloride and other osmotic pressure regulators, add appropriate amount of water to 1000 ml, and the pH is about is 3.0.

[0046] Preparation administration method: intravenous infusion.

preparation example 3

[0048] a: tirapazamine 0.01 g

[0049] b: citric acid 0.0168g

[0050] c: 0.004 grams of sodium hydroxide

[0051] Take 300 ml of water to dissolve b and c. After complete dissolution, heat up appropriately to keep the solution temperature at about 55°C, slowly add a, stir to dissolve completely, after cooling to room temperature, add glucose and other osmotic pressure regulators, add appropriate amount of water to 1000 ml, pH is about 5.3 .

[0052] Preparation administration method: intravenous infusion.

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Abstract

The invention provides a Tirapazamine parenteral hydrous preparation and a preparation method thereof. The preparation comprises the following basic components: a citrate buffer solution and Tirapazamine or available salts thereof, wherein the concentration of the buffer solution is 0.02-0.99 mmol / l, and the buffer solution is acceptable in medical preparations; the concentration of the Tirapazamine or available salts thereof is 0.056-0.091 mmol / l; and the pH value of the preparation is 3.0-6.5. The preparation 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 an aqueous preparation of tirapazamine for parenteral administration 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 increas...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/53A61P35/00
Inventor 孟昭珂郭殿武杜九龄
Owner HANGZHOU MINSHENG PHARM CO LTD
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