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Stable mitoxantrone preparation

A technology of mitoxantrone and preparation, applied in the field of mitoxantrone preparation, can solve problems such as unsatisfactory

Active Publication Date: 2022-06-03
SHENZHEN CHINA RESOURCES JIUCHUANG MEDICAL & PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] However, the above preparations are still unsatisfactory in terms of stability.

Method used

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  • Stable mitoxantrone preparation
  • Stable mitoxantrone preparation
  • Stable mitoxantrone preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] The selection of embodiment 1 preparation pH value

Embodiment 1-1

[0064] The composition and content of table 1 preparation

[0065]

[0066] Soak all utensils and vials with edetate disodium, weigh the prescribed amount of sodium chloride, acetic acid, sodium acetate, sodium metabisulfite and sodium acetate, add to the prescribed amount of water for injection, stir to dissolve, and add to the prescription after dissolving Measure mitoxantrone hydrochloride, stir for 30 minutes to dissolve, filter through 0.45 μm and 0.22 μm filter membranes, fill with nitrogen, crimp the cap, and sterilize at 121°C for 15 minutes.

Embodiment 1-2

[0068] The composition and content of table 2 preparation

[0069]

[0070] Soak all utensils and vials with edetate disodium, weigh the prescribed amount of sodium chloride, acetic acid, sodium acetate, sodium metabisulfite and sodium acetate, add to the prescribed amount of water for injection, stir to dissolve, and add to the prescription after dissolving Measure mitoxantrone hydrochloride, stir for 30 minutes to dissolve, filter through 0.45 μm and 0.22 μm filter membranes, fill with nitrogen, crimp the cap, and sterilize at 121°C for 15 minutes.

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Abstract

The invention relates to a stable mitoxantrone preparation. The mitoxantrone preparation comprises the following components in content: 0.1-20mg / ml of mitoxantrone and / or a pharmaceutically acceptable salt thereof; 3 to 18 mg / ml of sodium chloride; 0.015 to 1 mg / ml of acetic acid; 0 to 0.15 mg / ml of sodium acetate; 0 to 0.3 mg / ml of sodium pyrosulfite; 0 to 0.6 mg / ml of sodium sulfate; and a solvent. By using the formula provided by the invention, the technical problem that impurities are greatly increased in the preparation process of the mitoxantrone preparation can be solved, and the mitoxantrone preparation is stable in property and meets the requirements of clinical treatment.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a stable mitoxantrone preparation. Background technique [0002] Mitoxantrone or mitoxantrone hydrochloride was first synthesized by the laboratories of Murdock and Lederle in the United States in 1979 and its antitumor activity was proved. In 1987, the U.S. FDA approved the production of mitoxantrone hydrochloride injection, whose trade name was Novantrone. The chemical name of mitoxantrone hydrochloride is 1,4-dihydroxy-5,8-bis[[2-[(2-hydroxyethyl)amino]ethyl]amino]-9,10-anthraquinone dihydrochloride Salt, its structural formula is as shown in formula (I). [0003] [0004] Mitoxantrone or mitoxantrone hydrochloride is an anthracycline antineoplastic drug with a molecular structure similar to that of doxorubicin. It has a planar aromatic ring and is easily embedded in the base pairs of DNA double helices, forcing the two base pairs to separate. DNA grows, causin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/136A61K47/02A61K47/12A61P35/00
CPCA61K31/136A61K9/08A61K9/0019A61K47/02A61K47/12A61P35/00
Inventor 陈宁刘珺李丹杨战鏖涂菲娜蒋小涌黄权华赖宝林张翠荣张远杏刘瑞锦
Owner SHENZHEN CHINA RESOURCES JIUCHUANG MEDICAL & PHARMA CO LTD