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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-drying delivery, powder delivery, active ingredients of anhydride/acid/halide, etc. It can solve problems such as difficult water sublimation, gray color, and prolonged freeze-drying time , to achieve the effect of shortening the freeze-drying time, reducing the scrap rate and shortening the production cycle

Active Publication Date: 2009-02-25
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
  • Preparation of nedaplatin freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Preparation of nedaplatin freeze-dried powder injection (10mg specification) by common method

[0019] prescription

[0020]

[0021]

[0022] Take the prescription amount of nedaplatin and put it in a container, add 80% water for injection, stir to dissolve and mix evenly, then add the prescription amount of dextran, stir to dissolve and mix evenly, measure the content of the intermediate, and add water for injection after passing the test Make up to the full volume, filter it with a 0.22 μm microporous membrane until it becomes clear under aseptic conditions, fill the filtrate into a sterile vial, partially plug a butyl rubber stopper, put it on a plate, and send it to a freeze dryer. Close the door of the box, open the freeze dryer, use the heat-conducting oil to refrigerate the plate layer, so that the product temperature drops, when the sample reaches the eutectic point (about -10 °C), continue to freeze until the product temperature is lower than -25 °C, sto...

Embodiment 2

[0024] Preparation of nedaplatin freeze-dried powder injection (50mg specification) by common method

[0025] prescription

[0026]

[0027] Take the prescription amount of nedaplatin and put it in a container, add 80% water for injection, stir to dissolve and mix evenly, then add the prescription amount of dextran, stir to dissolve and mix evenly, measure the content of the intermediate, and add water for injection after passing the test Make up to the full volume, filter it with a 0.22 μm microporous membrane until it becomes clear under aseptic conditions, fill the filtrate into a sterile vial, partially plug a butyl rubber stopper, put it on a plate, and send it to a freeze dryer. Close the door of the box, open the freeze dryer, use the heat-conducting oil to refrigerate the plate layer, so that the product temperature drops, when the sample reaches the eutectic point (about -10 °C), continue to freeze until the product temperature is lower than -25 °C, stop the plate ...

Embodiment 3

[0029]

[0030] Take the prescription amount of nedaplatin and put it in a container, add 80% water for injection, stir to dissolve it and mix it evenly, then add the prescription amount of dextran, stir it to dissolve and mix it evenly, measure the content of the intermediate, and add the prescription amount after passing the test. Stir the ethanol to make the mixture evenly, and then make up to the full volume with water for injection. Under aseptic conditions, filter it with a 0.22 μm microporous membrane until it becomes clear. , put it on a plate, put it into the freeze dryer, close the door, open the freeze dryer, use the heat-conducting oil to refrigerate the plate layer, so that the product temperature drops, when the sample reaches the eutectic point (about -10 ℃), continue to freeze to the product temperature When the temperature is lower than -25℃, stop the plate cooling and open the condenser. When the temperature of the condenser reaches -40℃, open the vacuum sy...

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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 invention relates to a preparation method of nedaplatin freeze-dried powder injection. The nedaplatin freeze-dried powder injection prepared by the method can be used for head and neck cancer, lung small cell carcinoma, lung non-small cell carcinoma and esophageal cancer. , bladder cancer, testicular cancer, ovarian cancer, cervical cancer, etc. 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 incidence of cancer has increased at an average annual rate of 3-5%, and cancer death has become the seven major causes of human death. one. According to the WHO report, in 1997, about 6.2 million deaths from cancer, ranking third in human deaths after infectious diseases and cardiovascular diseases. The WHO held a tumor control program meeting in London. Karol Sikora (Lyon, France), director of the program, estimated that by 2020, th...

Claims

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Application Information

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