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A kind of mitomycin freeze-dried preparation for injection and preparation method thereof

A mitomycin, freeze-dried preparation technology, applied in the field of medicine, can solve the problem of high residual tert-butanol solvent, achieve the effect of increasing the solid content, reducing the level of related impurities and safety risks, and increasing the stability of the liquid medicine

Active Publication Date: 2022-07-01
KINDOS PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is still the problem of high residual tert-butanol solvent in its finished product

Method used

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  • A kind of mitomycin freeze-dried preparation for injection and preparation method thereof
  • A kind of mitomycin freeze-dried preparation for injection and preparation method thereof
  • A kind of mitomycin freeze-dried preparation for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] A lyophilized preparation of mitomycin for injection, in terms of mass, the raw materials for liquid preparation include 2 mg of mitomycin, 5 mg of mannitol, 0.5 ml of tert-butanol and 0.01 ml of propylene glycol, and the volume is adjusted to 1 ml by adding water.

Embodiment 2

[0046] A lyophilized preparation of mitomycin for injection, in terms of mass, the raw materials for liquid preparation include 4 g of mitomycin, 6 g of mannitol, 0.7 L of tert-butanol and 0.03 L of propylene glycol, and the volume is adjusted to 1 L by adding water.

Embodiment 3

[0048] A lyophilized preparation of mitomycin for injection, in terms of mass, the raw materials for liquid preparation include 2.5 g of mitomycin, 5 g of mannitol, 0.6 L of tert-butanol and 0.02 L of propylene glycol, and the volume is adjusted to 1 L by adding water.

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Abstract

The present invention provides a freeze-dried preparation of mitomycin for injection, which is characterized in that, by mass, the liquid preparation raw materials include 2-4 parts of mitomycin, 5-6 parts of mannitol, and 500 parts of tert-butanol. 700 parts and 10-30 parts of propylene glycol, add water to make up to 1000 parts. The product has no solvent residue problem and high stability.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a freeze-dried preparation of mitomycin for injection. Background technique [0002] Mitomycin is an anti-tumor drug isolated from the culture solution of actinomycetes. It is a commonly used periodic non-specific drug and is effective against a variety of solid tumors. It is one of the commonly used anti-tumor drugs in various countries. Mitomycin is thermally stable, has a high melting point (greater than 360°C), is freely soluble in organic solvents, and is slightly soluble in water, and mitomycin is extremely unstable in aqueous solution, and its degradation process is affected by acid and alkali. and temperature effects. [0003] Since mitomycin is slightly soluble in water, its solubility in room temperature water is about 1.0 mg / mL, and the solubility decreases with decreasing temperature. The minimum specification of the original research product that has been listed i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/10A61K31/407A61P35/00
CPCA61K9/0019A61K9/19A61K47/10A61K31/407A61P35/00
Inventor 文娅娅谢谦史宣宇田欣欣
Owner KINDOS PHARM CO LTD
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