Paclitaxel injection, and its prepn. method

A technology of paclitaxel and injection, applied in the field of medicine, can solve the problems of inability to replace completely, and achieve the effects of reducing burden, improving stability and having less side effects

Inactive Publication Date: 2006-01-25
重庆华立药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In short, including other preparations such as microemulsions, proliposomes, topical administration, etc., because of certain problems in encapsulation efficiency, stability, side effects, bioavailability or convenience of administration, etc., they cannot completely replace Paclitaxel Cremophor preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Example 1 Preparation of new paclitaxel injection

[0016] Measure 30 ml of absolute ethanol, add 15 g of soybean lecithin for injection, 1.66 g of cholesterol, and Tween-8050 g, heat and stir at 45°C to dissolve, add 600 mg of paclitaxel, stir until it dissolves, and add absolute ethanol to 100 ml. Filter it with a microporous membrane (0.22um), pack it, and perform routine disinfection.

Embodiment 2

[0017] Example 2 Preparation of new paclitaxel injection

[0018] Measure 20 ml of absolute ethanol, add 10 g of soybean phospholipid for injection, 0.1 g of sodium cholate, and Tween-805 g, heat and stir at 60°C to dissolve, add 500 mg of paclitaxel, stir to dissolve, add absolute ethanol to 100 Milliliters, filter with a medium-sized sand filter rod, sub-pack, and routinely disinfect.

Embodiment 3

[0019] Example 3 Preparation of new paclitaxel injection

[0020] Measure 5 ml of absolute ethanol and 5 ml of polyethylene glycol, mix them, add 12 g of soybean phospholipid for injection, 1.5 g of poloxamer (F68), and 0.1 g of sodium cholate, dissolve it by ultrasound, and add 400 mg of paclitaxel , Stir to dissolve, add absolute ethanol to 100 ml, filter with a vertical dissolving funnel (No. 6), sub-pack, and perform routine disinfection.

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PUM

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Abstract

A taxi-alcohol injection is prepared from taxi-alcohol, solvent for injection and stabilizer through dissolving the stabilizer in said solvent by thermal stirring or ultrasonic stirring, adding taxi-alcohol, stirring, filtering, loading it in containers and sterilizing. It has low toxic by-effect.

Description

Technical field [0001] The invention relates to the technical field of medicine, in particular to a new formulation and preparation method of a new type of paclitaxel injection prepared by dissolving the anticancer drug paclitaxel with an injection solvent and using an appropriate stabilizer. Background technique [0002] Paclitaxel (Paclitaxel, trade name Taxol) is a highly effective anticancer drug extracted from Taxus brevidolia (Pacific yew), a plant belonging to the Taxus family. It is a complex diterpenoid compound with a molecular formula of C 47 H 51 NO 14 , The relative molecular mass is 853.9. Paclitaxel has good anti-cancer activity and is used for the treatment of ovarian cancer, breast cancer, colon cancer, non-small cell lung cancer, neck cancer, melanoma, etc., with good curative effect. [0003] The solubility of paclitaxel in water is very small, almost insoluble in water (<0.004mg / ml), the bioavailability of oral administration is poor, and it can only be adm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/337A61K9/08A61P35/00
CPCA61K47/28A61K47/24A61K31/337A61K47/26A61K47/14A61K47/10A61K9/0019A61P35/00
Inventor 陈建明高保安黄尊动陈海生肖琴黄成安
Owner 重庆华立药业股份有限公司
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