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Preparation of nedaplatin freeze-dried powder injection

A technology of freeze-dried powder injection and nedaplatin, which is applied in the direction of freeze-dried delivery, powder delivery, anhydride/acid/halide active ingredients, etc. It can solve the problems of increased solution viscosity, gray color, and prolonged freeze-drying time , to achieve the effects of shortened production cycle, reduced scrap rate, and small moisture fluctuation

Active Publication Date: 2007-08-15
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The stability of nedaplatin freeze-dried powder injection prepared by using dextran as the backbone agent is greatly improved, and it can be stored stably for a long time (24 months). However, with the increase of the amount of dextran, the viscosity of the solution increases and water sublimation becomes difficult , the freeze-drying time is prolonged, and unqualified shapes such as delamination and shrinkage are prone to appear. Some nedaplatin freeze-dried powder injections are destroyed during the heating process of freeze-drying because the water cannot be sublimated smoothly, and the color turns gray, even in the molten solution. black precipitate

Method used

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  • Preparation of nedaplatin freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Ordinary method to prepare nedaplatin freeze-dried powder injection (10mg specification)

[0019] prescription

[0020] Nedaplatin 10g

[0021] Dextran 30g

[0022] Add water for injection to 2500ml

[0023]

[0024] A total of 1000 bottles were made

[0025] Take the prescribed amount of nedaplatin and put it in a container, add 80% of the water for injection, stir to dissolve and mix evenly, then add the prescribed amount of dextran, stir to dissolve and mix evenly, measure the content of the intermediate, add water for injection after passing the test Dilute to the full volume, and under sterile conditions, filter with a 0.22 μm microporous membrane until clear, fill the filtrate in a sterile vial, partially plug it with a butyl rubber stopper, put it into a plate, and send it to a freeze dryer. Close the box door, turn on the freeze dryer, and use heat transfer oil to cool the plate layer to lower the product temperature. Whe...

Embodiment 2

[0027] Ordinary method to prepare nedaplatin freeze-dried powder injection (50mg specification)

[0028] prescription

[0029] Nedaplatin 50g

[0030] Dextran 150g

[0031] Add water for injection to 10000ml

[0032]

[0033] A total of 1000 bottles were made

[0034] Take the prescribed amount of nedaplatin and put it in a container, add 80% of the water for injection, stir to dissolve and mix evenly, then add the prescribed amount of dextran, stir to dissolve and mix evenly, measure the content of the intermediate, add water for injection after passing the test Dilute to the full volume, and under sterile conditions, filter with a 0.22 μm microporous membrane until clear, fill the filtrate in a sterile vial, partially plug it with a butyl rubber stopper, put it into a plate, and send it to a freeze dryer. Close the box door, turn on the freeze dryer, and use heat transfer oil to cool the plate layer to lower the product temperature...

Embodiment 3

[0036] Nedaplatin 10g

[0037] Dextran 30g

[0038] Ethanol 25ml

[0039] Add water for injection to 2500ml

[0040]

[0041] A total of 1000 bottles were made

[0042]Take the prescribed amount of nedaplatin and put it in a container, add 80% of the water for injection, stir to dissolve and mix evenly, then add the prescribed amount of dextran, stir to dissolve and mix evenly, measure the content of the intermediate, and add the prescribed amount after passing the test Stir with ethanol to make the mixture even, then dilute to the full volume with water for injection, filter it with a 0.22 μm microporous membrane under sterile conditions, fill the filtrate into a sterile vial, and partially plug it with a butyl rubber stopper , put it on a plate, send it to the freeze dryer, close the door, turn on the freeze dryer, use heat transfer oil to cool the plate layer, so that the product temperature drops, and when the sample reaches the eutectic p...

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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. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/19A61K9/19A61P35/00
Inventor 叶东陈祥峰
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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