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Composition of taxone compound, and preparation method and application thereof

A technology of taxanes and compositions, which is applied in the field of taxane pharmaceutical compositions and their preparation, can solve problems such as poor stability, achieve the effects of increasing stability, facilitating clinical use, and reducing allergic reactions

Inactive Publication Date: 2009-07-22
南通集智知识产权服务有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since vegetable oil cannot be removed by lyophilization, it is actually a semi-solid preparation with poor stability at room temperature
Virtually all solutions using vegetable oils for solubilization suffer from poor stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Paclitaxel 20mg

[0043] Macrogol 400 200mg

[0044] Tween-80 850mg

[0045] Sodium dihydrogen phosphate 100mg

[0046] Mannitol 900mg

[0047] Citric acid amount

[0048] Water for injection to 10ml

[0049] Mix Paclitaxel, Polyethylene Glycol 800 and Tween 80 fully, stir, add dissolved sodium dihydrogen phosphate and mannitol aqueous solution, mix, adjust pH to 4 with citric acid solution, add 0.1% activated carbon to the solution and stir for 20 minutes . After the solution was decarbonized by coarse filtration with a 0.8 μm filter membrane, it was sterilized with a 0.22 μm filter membrane and dispensed into vials.

Embodiment 2

[0051] Docetaxel 20mg

[0052] Propylene Glycol 100mg

[0053] Tween-60 500mg

[0054] Potassium chloride 50mg

[0055] Glycine 600mg

[0056] Water for injection to 5ml

[0057] Docetaxel, propylene glycol, and Tween 60 were thoroughly mixed and stirred, an aqueous solution in which potassium chloride and glycine had been dissolved was added, mixed, and 0.1% activated carbon was added and stirred for 30 minutes. After the solution was decarbonized by coarse filtration with a 0.8 μm filter membrane, it was sterilized with a 0.22 μm filter membrane and dispensed into vials.

Embodiment 3

[0059] Paclitaxel 30mg

[0060] Macrogol 400 1000mg

[0061] Tween-40 2000mg

[0062] Sodium chloride 500mg

[0063] Lactic acid amount

[0064] Mannitol 3000mg

[0065] Water for injection to 30ml

[0066] Thoroughly mix paclitaxel, polyethylene glycol 400 and Tween 40, add aqueous solution in which sodium chloride and mannitol have been dissolved, mix, adjust pH to 5 with lactic acid solution, add 0.1% activated carbon to the solution and stir for 20 minutes. After the solution was decarbonized by coarse filtration with a 0.8 μm filter membrane, it was sterilized with a 0.22 μm filter membrane and dispensed into vials.

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PUM

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Abstract

The invention discloses a drug composition of taxanes, which comprises taxane compounds with effective dosage for treatment, a surfactant, a cosolvent and a stabilizer, wherein the cosolvent is selected from one or a mixture of more of polyethylene glycol, propylene glycol, glycerine or ethylene glycol; and the stabilizer is selected from hydrochloride, carbonate, phosphate and nitrate or a mixture of hydrochloride, carbonate, phosphate and nitrate. The composition can be an injection, a frozen dry powder needle or a kit for combined use. The composition can improve the solubility and stability of the taxane compounds. The invention also discloses a method for preparing the drug composition and application of the drug composition.

Description

technical field [0001] The invention relates to a taxane pharmaceutical composition, in particular the invention discloses a taxane pharmaceutical composition for injection and a preparation method thereof, belonging to the field of medicine. Background technique [0002] Taxane compounds are a class of anticancer compounds with a taxane skeleton structure, and their mechanism of action is to stimulate the polymerization of cathelicidins, promote the assembly of microtubule dimers into microtubules, and stabilize microtubules to inhibit microtubules. The dynamic reorganization of the reticulum ultimately stops cell proliferation at the quiescent stage of mitosis, thereby acting as a cytotoxic agent. At present, paclitaxel and docetaxel are the most used taxane compounds, which have been widely used in breast cancer, ovarian cancer, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), squamous cell carcinoma of the head and neck and treatment of primary and met...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/337A61K9/08A61K9/19A61K47/34A61K47/02A61K47/04A61J1/00A61P35/00A61K47/10
Inventor 郝守祝
Owner 南通集智知识产权服务有限公司
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