Preparation of nedaplatin freeze-dried powder injection

Abstract

This invention relates to a preparation method of freeze-dried injection of nedaplatin.nedaplatin freeze-dried injection prepared with the inventive method can be used as therapeutic drug of cancer. The invention improves the stability of nedaplatin during lyophilization and shortens the period of lyophilization through adding ethanol during preparation process. the preparation method comprises adding water for injection 80% of nedaplatin into nedaplatin, stirring for dissolving, adding dextran, stirring for dissolving, determing the content of intermediate, adding ethanol 1-10% of the cumulative volume of the solution, adding water for injection to full dose, filtrating with 0.22 mu m millipore filter under aseptic condition, encapsulating in sirin bottle, plugging, freeze drying, rolling the opening, testing, and packaging. The optimum amount of ethanol is 1-5% of cumulative volume of the solution.

Description

technical field

[0001] The present invention relates to a preparation method of nedaplatin freeze-dried powder injection, and the nedaplatin freeze-dried powder injection prepared by the method can be used as a medicine for head and neck cancer, small cell lung cancer, non-small cell lung cancer, esophagus cancer, etc. , Bladder cancer, testicular cancer, ovarian cancer, cervical cancer and other therapeutic drugs. Background technique

[0002] Since the second half of the 20th century, the incidence and death of cancer have been increasing year by year, especially since the 1970s, the number of cancer cases has increased at an average annual rate of 3-5%, and cancer death has become one of the seven major causes of death for human beings. one. According to the WHO report, the number of cancer deaths in 1997 was about 6.2 million, ranking third among human deaths after infectious diseases and cardiovascular diseases. WHO held a tumor control planning conference in London. ...

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