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Mitomycin freeze-drying preparation for injection and preparation method of mitomycin freeze-drying preparation

A technology for mitomycin and freeze-dried preparations, applied in the field of medicine, can solve the problem of high residual tert-butanol solvent, and achieve the effects of improving solid content, improving solubility and good stability

Active Publication Date: 2021-08-03
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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  • Mitomycin freeze-drying preparation for injection and preparation method of mitomycin freeze-drying preparation
  • Mitomycin freeze-drying preparation for injection and preparation method of mitomycin freeze-drying preparation
  • Mitomycin freeze-drying preparation for injection and preparation method of mitomycin freeze-drying preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] A freeze-dried preparation of mitomycin for injection, in terms of mass, the liquid preparation raw materials include 2 mg of mitomycin, 5 mg of mannitol, 0.5 ml of tert-butanol and 0.01 ml of propylene glycol, and add water to make up to 1 ml.

Embodiment 2

[0046] A freeze-dried preparation of mitomycin for injection, in terms of mass, the liquid preparation raw materials include 4 g of mitomycin, 6 g of mannitol, 0.7 L of tert-butanol and 0.03 L of propylene glycol, and add water to make up to 1 L.

Embodiment 3

[0048] A freeze-dried preparation of mitomycin for injection, in terms of mass, the dosing raw materials include 2.5 g of mitomycin, 5 g of mannitol, 0.6 L of tert-butanol and 0.02 L of propylene glycol, and add water to make up to 1 L.

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Abstract

The invention provides a mitomycin freeze-drying preparation for injection, wherein the mitomycin freeze-drying preparation is characterized in that the mitomycin freeze-drying preparation comprises the preparation raw materials by mass: 2-4 parts of mitomycin, 5-6 parts of mannitol, 500-700 parts of tertiary butanol, 10-30 parts of propylene glycol, and water added until the volume is 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 antineoplastic drug isolated from the culture medium 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 antineoplastic drugs in various countries. Mitomycin is thermally stable and has a high melting point (greater than 360°C). It is freely soluble in organic solvents and slightly soluble in water. Mitomycin is extremely unstable in aqueous solution. The degradation process is affected by acid and alkali. and temperature effects. [0003] Since mitomycin is slightly soluble in water, its solubility in water at room temperature is about 1.0 mg / mL, and the solubility decreases with decreasing temperature. The minimum specification of the marketed original research product is 5mg / bot...

Claims

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Application Information

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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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