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Vinorebin powder injection and preparation method

A technology for vinorelbine and injection, which is applied in powder delivery, antineoplastic drugs, drug combination, etc. It can solve the problems of insufficient drug efficacy and achieve the effects of good product stability, advanced manufacturing technology, and improved degradation products

Inactive Publication Date: 2003-08-27
杭州新望族科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, cancer is a disease with a very high mortality rate in the world, and has become the enemy of mankind. Many countries in the world are investing a lot of financial and material resources in the research of anti-cancer and cancer treatment, especially the development of some cancer treatment drugs. There has been some progress in specific medicines, but so far there has not been a substantial breakthrough, mainly because the medicines are not effective enough.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1, take vinorelbine bitartrate 13.85g (equivalent to vinorelbine 10g), and mannitol 10g, add sterilized water for injection 2000ml, stir to make it dissolve, measure the pH value of solution 3.0~4.5, add medicine Filter with activated carbon, and then filter the filtrate with a 0.22 μm microporous membrane filter, and fill it into a sterilized vial. Pre-freeze at -30~-40°C for 2~3 hours, sublimate and dry at -36~-20°C for 9 hours, then dry at 30°C for 25~30 hours, cover and crimp, and pack with vinorelbine as the main drug , mannitol powder injection as filler.

Embodiment 2

[0025] Example 2, prepared by freeze-drying sub-packaging method, weighed vinorelbine bitartrate 41.55g (equivalent to vinorelbine 30g) in a clean room, dextran 14g, sorbitol 6g were placed in a sterilized container together, Add 2000 ml of sterilized water for injection, stir to make it dissolve, add medicinal activated carbon to filter, and then filter the filtrate with a 0.22 μm microporous membrane sterilizer to obtain a sterile solution. Place the aseptic solution in a large tray for aseptic freeze-drying, crush it, measure the content of vinorelbine in the freeze-dried powder, pack it into vials according to the converted weight of vinorelbine, crimp the cap and seal it, and pack it.

Embodiment 3

[0026] Embodiment 3, decompression drying packing method, take by weighing vinorelbine bitartrate 27.7g (vinorelbine 20g) in the clean room, dextran 20g is placed in the sterilized container, add sterilized water for injection 2000ml, stir Make it dissolve, add medicinal activated carbon, filter, and then filter the filtrate with a 0.22μm microporous membrane sterilizer to obtain a sterile solution, place the sterile solution in a large plate, dry it under reduced pressure, and crush it according to the regulations The weight is divided into sterilized vials, crimped and sealed, and packaged.

[0027] Recipe serial number

[0028] The above-mentioned vinorelbine of the present invention can be a kind of free base, also can be a kind of mono-salt or double-salt prepared by reacting with an acid of tartaric acid, citric acid, maleic acid, phosphoric acid, sulfuric acid, hydrochloric acid, carbonic acid compound. This single-salt or double-salt compound is used as the ...

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PUM

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Abstract

The present invention relates to an injection vinorebin powder injection preparation and its preparation method. It is made up by using vinorebin as main medicine or adding at least one of dextran, mannitol and sorbitol as filling agent, using at least one of solvents of water for injection, acetone and ethyl alcohol to dissolve them to obtain solution, then decolouring with active carbon, filtering by using microporous filtering film, then dehydration drying by using freeze-drying or reduced pressure drying to obtain the invented powder injection for curing the diseases of non-small cell lung cancer, mammary cancer, oophoroma and lymphoma, etc.

Description

technical field [0001] The present invention relates to a new preparation for intravenous injection containing vinorelbine as an active ingredient for the treatment of non-small cell lung cancer, breast cancer, ovarian cancer and lymphoma, i.e. injection powder , and its formulations include freeze-dried products for injection and sterile subpackaged products for injection. technical background [0002] At present, cancer is a disease with a very high mortality rate in the world, and has become the enemy of mankind. Many countries in the world are investing a lot of financial and material resources in the research of anti-cancer and cancer treatment, especially the development of some cancer treatment drugs. There has been some progress in specific medicines, but so far there has not been a substantial breakthrough, mainly because the medicines are not effective enough. [0003] Vinorelbine is an alkaloid extracted from Catharanthus roseus (Catharanthus roseus or Vinca rose...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/4375A61P35/00
Inventor 黄弈
Owner 杭州新望族科技有限公司
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