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Docetaxel freeze-dried powder-injection, and its prepn. method

A freeze-dried powder injection and docetaxel technology, which is applied in the field of drug preparation, can solve the problems of reducing the content of the main drug docetaxel, poor quality stability of injections, easy oxidation and hydrolysis, etc., to facilitate industrial production and product Good stability, increase the effect of quality stability

Inactive Publication Date: 2006-11-29
YUNNAN YUYAO BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because docetaxel is easily oxidized and hydrolyzed when placed in the solution for a long time, thereby reducing the content of the main drug docetaxel, the quality stability of the injection is poor

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The combination of docetaxel and auxiliary materials and the ratio of parts by weight are as follows: 1 part of docetaxel, 25 parts of Tween-80, 25 parts of polyethylene glycol 400, and 35 parts of mannitol.

[0023] Prepare as follows:

[0024] Take 20g of docetaxel, 500g of Tween-80, 500g of polyethylene glycol 400, and 700g of mannitol, add water for injection to 4800ml (water for injection with 80% prescription volume), stir to dissolve the docetaxel until the solution is clear Add 0.2% activated carbon of the total amount of raw and auxiliary materials, stir at room temperature for 30 minutes, use a 1.0 μm microporous membrane for coarse filtration, add water for injection to the filtrate to 6000 ml (prescription volume), and then use a 0.22 μm microporous membrane to sterilize and filter; The obtained filtrate is inspected for clarity, pH and content; after passing the inspection, the subpackage volume determined according to the fine filtrate content is filled wi...

Embodiment 2

[0026] The combination of docetaxel and auxiliary materials and the ratio of parts by weight are: 1 part of docetaxel, 8 parts of glycerin, 3 parts of ethanol, 1 part of sodium metabisulfite, and 1 part of disodium edetate.

[0027] Prepare as follows:

[0028] Take 10g of docetaxel, 80g of glycerin, 30g of ethanol, 10g of sodium metabisulfite, and 10g of disodium edetate, add water for injection to 4800ml (water for injection with 80% prescription volume), and stir to dissolve the docetaxel into the solution Clarify; add activated carbon of 0.2% of the total amount of raw and auxiliary materials, stir at room temperature for 30 minutes, coarsely filter with a 1.0 μm microporous membrane, add water for injection to the filtrate to 6000ml (prescription volume). The following steps are the same as in Example 1.

Embodiment 3

[0030] The combination of docetaxel and auxiliary materials and the ratio of parts by weight are: 1 part of docetaxel, 10 parts of glycerin, 5 parts of sodium metabisulfite, and 20 parts of propylene glycol.

[0031] Prepare as follows:

[0032] Get docetaxel 10g, glycerol 100g, sodium metabisulfite 50g, propylene glycol 200g, add water for injection to 4800ml (the water for injection of 80% prescription quantity), stir to make docetaxel dissolve until the solution is clear. Add activated carbon of 0.2% of the total amount of raw and auxiliary materials, stir at room temperature for 30 minutes, filter with a 1.0 μm microporous membrane, and add water for injection to the filtrate to 6000ml (recipe volume). The following steps are the same as in Example 1.

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PUM

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Abstract

A freeze-dried powder injection of Duoxitasai is proportionally prepared from Duoxitasai and the auxiliary chosen from alcohol, tween-80, glycerin, Na2EDTA, propanediol, polyethanediol 400, mannitol and sodium pyrosulfite. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to docetaxel freeze-dried powder injection and a preparation method thereof. technical background [0002] Docetaxel, also known as docetaxel, is a paclitaxel antineoplastic drug obtained by semi-synthesis with 10-DAB as the mother nucleus skeleton. For the treatment of ovarian cancer, breast cancer and non-small cell lung cancer that are refractory to conventional chemotherapy. [0003] Docetaxel is currently available in the form of injection. This product is a yellow to yellow-brown transparent viscous liquid, which is a liquid obtained by dissolving anhydrous docetaxel in Tween-80. It is equipped with a special solvent of 13% (w / w) ethanol aqueous solution for injection. For clinical use, first suck out all the solvent for injection, inject it into the corresponding docetaxel solution bottle, and mix it manually by inversion for at least 40 seconds, then leave the...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/337A61K47/04A61K47/10A61K47/18A61K47/06A61K47/34A61P35/00A61K47/26
Inventor 高家雄
Owner YUNNAN YUYAO BIOPHARM CO LTD
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