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Vinflunine pharmaceutical composition and method of producing the same and application of the same

A technology of vinflunine and a composition is applied in the field of vinflunine pharmaceutical compositions, which can solve the problems of inability to obtain vinflunine salt freeze-dried preparations, poor stability of medicinal liquid, etc. good stability

Inactive Publication Date: 2008-02-27
QILU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, studies have shown that the vinflunine bitartrate powder injection sample prepared by commonly used lyophilized excipients such as mannitol at a conventional dosage has a clarity greater than No. 2 and poorer stability than the vinflunine bitartrate before freeze-drying. Obtaining an ideal and highly stable freeze-dried formulation of vinflunine salt

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050]Weigh 205.05 g of hydroxypropyl-β-cyclodextrin, stir and dissolve in 800 ml of sterile water for injection, add 34.175 g of vinflunine bitartrate (equivalent to 25 g of vinflunine) and stir to dissolve it, and measure the pH value of the solution at 3.0- 4.5. Set the volume to 1000ml, add activated carbon for needles, filter, and then filter the filtrate with a 0.22μm microporous membrane, and put it in a sterile vial. Freeze in a freeze-drying cabinet to about -45°C for 2-3 hours, sublimate and dry at -10°C to 0°C for 9 hours, and then dry at 38°C for 5-10 hours, then fill the box with nitrogen, put a stopper on it, and seal it with a gland. Obtain Vinflunine Powder for Injection.

Embodiment 2

[0052] Weigh 136.7g of hydroxypropyl-β-cyclodextrin, 0.6g of citric acid, and 0.6g of sodium citrate, add 800ml of sterile water for injection and stir to dissolve, add 34.175g of vinflunine bitartrate (equivalent to 25g of vinflunine) Stir to dissolve, measure the pH value of the solution to 3.0-4.5, set the volume to 1000ml, add activated carbon for needles, filter, and then filter the filtrate with a 0.22μm microporous membrane, and put it in a sterile vial. Freeze in a freeze-drying cabinet to about -45°C for 2-3 hours, sublimate and dry at -10 to 0°C for 9 hours, and then dry at 38°C for 8-10 hours, take out the box, add a stopper, seal with a gland, and pack for injection. Changchun Flunine Powder Injection.

Embodiment 3

[0054] Weigh 160.0 g of acetyl-γ-cyclodextrin, 0.6 g of citric acid, and 0.8 g of sodium citrate, add 800 ml of sterile water for injection and stir to dissolve, add 34.175 g of vinflunine bitartrate (equivalent to 25 g of vinflunine) and stir Make it dissolve, measure the pH value of the solution to 3.0-4.5, set the volume to 1000ml, add activated carbon for needles, filter, and then filter the filtrate with a 0.22 microporous filter membrane, and put it in a sterile vial. Freeze in a freeze-drying cabinet to about -45°C for 2-3 hours, sublimate and dry at -10 to 0°C for 9 hours, and then dry at 38°C for 5-10 hours, fill the box with nitrogen, put a stopper on it, seal it with a gland, and pack it. .

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Abstract

The invention relates to a pharmaceutical composition of Vinflunine, which comprises Vinflunine as the active constituent, pharmaceutically acceptable salts and cyclodextrin, wherein each 1 part of Vinflunine and its pharmaceutically acceptable salt are mixed with a maximum of 0. 5-100 parts by weight ratio of cyclodextrin, and freeze dried injection is prepared. The invention also relates to the process for preparing the composition, and its use in preparing non-stomach administering pharmaceutical products for the treatment of cancer.

Description

technical field [0001] The invention relates to a vinflunine pharmaceutical composition, in particular to a vinflunine freeze-dried powder injection pharmaceutical composition for parenteral administration, a preparation method thereof, and a pharmaceutical application thereof for treating cancer, belonging to the technical field of medicine . Background technique [0002] Vinflunine was originally the latest vinblastine drug screened by French company Pierre Fabre. It is derived from vinorelbine. By inhibiting tubulin polymerization, cell division is stopped in mid-mitosis. It is a cycle-specific anticancer drug. . It can be used in the treatment of non-small cell lung cancer, bladder cancer, breast cancer, mesothelioma, melanoma, kidney cancer and other tumors. [0003] It is reported in the literature that the pharmaceutically acceptable salts of vinflunine are in the form of bitartrate, sulfate and the like. The raw material of vinflunine bitartrate is very unstable a...

Claims

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Application Information

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IPC IPC(8): A61K31/475A61K9/19A61K47/40A61P35/00
Inventor 徐先艳杨清敏刘宝明张明会王晶翼
Owner QILU PHARMA
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