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mitomycin

Antineoplastic drugs

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Mitomycin, an anti-tumor drug isolated from the culture medium of actinomycetes, is effective for many solid tumors and is one of the commonly used cycle non-specific drugs. Structurally, it has Benzoquinone 、 Uratan and Ethylene imine Three effective groups. After being activated by reductase in cells, it can play a role in depolymerizing DNA and antagonizing DNA replication. At high concentration, it also inhibits the synthesis of RNA and protein. It mainly acts in late G1 and early S periods. It also works under acidic and anaerobic conditions. Drug resistance is mainly due to the decrease of cell membrane permeability, resulting in the decrease of intracellular concentration; Accelerated degradation and so-called mutation selection mechanism.

Chinese name

mitomycin^[4]

Foreign name

Mitomycin（MMC）^[3]

Whether included

yes

Dosage form

injection^[4]

Drug type

Other cytotoxic antibiotics and anti-tumor drugs^[3-4]

Science popularization in China

Committed to authoritative science communication

The certification expert of this term is

Zhang Zheng | Pharmacist in charge

Pharmacy Department of Beijing Chaoyang Hospital to examine

Qiu Kui | Pharmacist in charge

Pharmacy Department of Beijing Chaoyang Hospital to examine

catalog

essential information

Chinese name: mitomycin^[4]
Foreign name: Mitomycin（MMC）^[3]

Whether included in medical insurance: yes
Dosage form: injection^[4]
Drug type: Other cytotoxic antibiotics and anti-tumor drugs^[3-4]

indication

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It is effective for a variety of solid tumors, especially for gastrointestinal cancer, and is one of the commonly used anti-tumor drugs in various countries.

clinical application

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1. Intravenous injection: 6-8mg each time, dissolved with sodium chloride injection, and then injected intravenously once a week. It can also be repeated every 6 to 8 weeks, once every 10 to 20 mg.

2. Arterial injection: the dose is the same as that of intravenous injection.

3. Intracavitary injection: 6-8mg each time.

4. Combined chemotherapy: FAM (fluorouracil, adriamycin, mitomycin) is mainly used for gastrointestinal tumors.

Adverse reactions

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The toxicity of this product is similar to that of other alkylating agents, mainly bone marrow suppression and digestive tract reaction. In addition, it is also toxic to the kidney and lungs. Some patients may cause fever, fatigue, muscle pain and hair loss. Blood picture should be checked strictly during medication. This product can stimulate the local area and cannot be leaked out of the blood vessel.

matters needing attention

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This product has toxic effect on kidney and lung. The product should be applied within 4-6 hours after dissolution.

Drug contraindication

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Chickenpox or zoster It is forbidden for patients, pregnant women and lactating women.

Drug interaction

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The combined use of this product and doxorubicin can increase cardiac toxicity. It is recommended that the total amount of doxorubicin be limited to 450mg/m of body surface area two following. And vitamin C , B6 and other compatible intravenous applications can significantly reduce the efficacy of this product. Prohibit live virus vaccination and avoid oral administration during medication Polio vaccine 。

Note: The above contents are only for introduction. Drug use must be carried out by regular hospitals under the guidance of doctors.

Pharmacopoeia information

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essential information

This product is 6-amino-1,1 α ,2,8,8 α ,8 b -Hexahydro-8 - (hydroxymethyl) - 8 α -Methoxy-5-methylaziridino [2 ', 3': 3,4] pyrrolo [1,2- α ]Indole-4,7-diketocarbamate, calculated as dry product, contains mitomycin (C fifteen H eighteen N four O five ）Not less than 97.0%.

character

This product is cyan purple powder or grayish purple freeze-dried powder or loose block, odorless, unstable in acid, alkali and sunlight.^[2]

This product is slightly soluble in water, methanol or ethanol, and almost insoluble in ether.

identify

1. Take this product, add water to dissolve and dilute it to make a solution containing lO µ g per 1ml, and determine it by ultraviolet visible spectrophotometry (general rule 0401). The maximum absorption is at the wavelength of 217nm and 365nm.

2. In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.

3. The infrared absorption spectrum of this product should be consistent with the control spectrum (spectrum set 918 figure).

inspect

Crystallinity

Take a small amount of this product and check it according to the law (general rule 0981). It should meet the requirements.

Take this product, add water to make a suspension containing 5mg per 1mL, and determine according to the law (general rule 0631), the pH value should be 5.5~7.5.

Related substances

Determine according to the high performance liquid chromatography (general rule 0512).

Test solution: Take a proper amount of this product, add methanol to dissolve and dilute it to make a solution containing 2mg per 1mL.

Reference solution: Precisely measure an appropriate amount of the test solution and dilute it with methanol to prepare a solution containing 10 µ g per 1mL.

System suitability solution: Take appropriate amount of cinnamamide reference substance and mitomycin, add methanol to dissolve and dilute them to prepare a mixed solution containing 0.08mg and 0.2mg per 1mL respectively.

Mitomycin locating solution: take 5mg of mitomycin reference substance, add 10mL of water, dissolve it by ultrasound, add 0.2mL of 0.01mol/L sodium hydroxide solution, shake it up, and place it at room temperature for 10 minutes.

Chromatographic conditions: using eighteen burned silica gel as filler; With 0 077% Eucalyptus acetate solution methanol (so: 20) was mobile phase A; with

0.077% acetic acid is mobile phase B compared with solution methanol (50:50), which is attached as follows:

Linear gradient elution; The column temperature is 3o · c; The detection wavelength is 254nm; The injection volume 5 is called.

Time (minutes)	Mobile phase A (%)	Mobile phase B (%)
zero	one hundred	zero
ten	one hundred	zero
thirty	zero	one hundred
forty-five	zero	one hundred
fifty	one hundred	zero

System suitability requirements: in the chromatogram of system suitability solution, the retention time of mitomycin peak is about 21 minutes, the relative retention time of cinnamamide peak is about 1.3, and the resolution between mitomycin peak and cinnamamide peak should be greater than 15.0.

Determination method: Precisely measure 5 µ L of the test solution and 5 µ L of the reference solution, inject them into the liquid chromatograph, and record the chromatogram.

Limit: if there is an impurity peak in the chromatogram of the test solution, the cinnamamide peak shall be calculated according to the corrected peak area (multiplied by the correction factor 0.35), which shall not be greater than the main peak area of the reference solution (0.5%), and the peak area of mitomycin albicans (relative retention time is about 0.5) shall not be greater than the main peak area of the reference solution (0.5%), The peak area of other single impurities shall not be greater than the main peak area of the reference solution (0.5%), the sum of the peak areas of each impurity shall not be greater than 4 times (2.0%) of the main peak area of the reference solution according to the corrected peak area, and the peak less than 0.1 times of the main peak area of the reference solution shall be ignored.

Loss on drying

Take this product, use phosphorus pentoxide as the desiccant, and dry it at 60 ℃ to constant weight under reduced pressure. The weight loss shall not exceed 2.0% (General Rule 0831).

Bacterial endotoxin

Take this product and check according to the law (general rule 1143). The amount of endotoxin in each 1mg of mitomycin should be less than 10EU. (for injection)

Assay

Determine according to the method of high performance liquid chromatography (general rule 0512).

Test solution

Take an appropriate amount of this product, weigh it precisely, add methanol to dissolve it and dilute it quantitatively to prepare a solution containing about 0.2mg per 1mL.

Reference solution

Take an appropriate amount of mitomycin reference substance, weigh it precisely, add methanol to dissolve it and dilute it quantitatively to prepare a solution containing about 0.2mg per 1mL.

System suitability solution

See related substances.

Chromatographic conditions

Octadecylsilane bonded silica gel is used as the filler, 0.077% ammonium acetate solution methanol (70:30) is used as the mobile phase, the detection wavelength is 365nm, and the injection volume is 5 µ L.

System suitability requirements

In the chromatogram of system suitability solution, the resolution between mitomycin peak and cinnamamide peak should meet the requirements, and the trailing factor of mitomycin peak should not be greater than 1 3 。

Assay

Accurately measure the test solution and the reference solution, respectively inject them into the liquid chromatograph, and record the chromatogram. Calculate by peak area according to external standard method.