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Medicine composition of Taxane compounds, preparing method and use

A technology of taxanes and compositions, which is applied in the direction of drug combinations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of inconvenient clinical use, complicated preparation process, and poor stability. Achieve the effect of being convenient for clinical use, simple preparation process and increasing stability

Inactive Publication Date: 2007-08-29
郝守祝 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The concentrated solution is equipped with a special solvent of 13% ethanol, which can be injected after diluting the concentrated solution with 13% ethanol, which is very inconvenient for clinical use and greatly limits its clinical application
[0003] In order to solve the solubility problem of taxane compounds, many articles have reported their preparation as emulsions and microemulsions, cyclodextrin inclusion complexes, liposomes, nanoparticles and other preparations. However, the above preparations have preparation Disadvantages such as complicated process, high cost and poor stability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Docetaxel 20mg

[0032] Macrogol 200 100mg

[0033] Tween-80 300mg

[0034] Mannitol 300mg

[0035] Water for injection to 3ml

[0036] Mix and stir docetaxel, polyethylene glycol 200 and Tween 80, add mannitol aqueous solution, mix, 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. According to "Chinese Pharmacopoeia 2005 edition (two)" appendix IXA method, be placed in Nessler's colorimetric tube, visual inspection under the fluorescent lamp, compare clear and transparent with water, not darker than No. 1 turbidimetric solution.

Embodiment 2

[0038] Docetaxel 20mg

[0039] Macrogol 400 350mg

[0040] Tween-80 300mg

[0041] Mannitol 250mg

[0042] Water for injection to 5ml

[0043] Mix and stir docetaxel, polyethylene glycol 400 and Tween 80, add mannitol aqueous solution, mix, 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. According to "Chinese Pharmacopoeia 2005 edition (two)" appendix IXA method, be placed in Nessler's colorimetric tube, visual inspection under the fluorescent lamp, compare clear and transparent with water, not darker than No. 1 turbidimetric solution.

Embodiment 3

[0045] Docetaxel 20mg

[0046] Macrogol 400 300mg

[0047] Tween-80 800mg

[0048] Mannitol 300mg

[0049] Water for injection to 3ml

[0050] Prepare docetaxel injection according to the method of embodiment 1, according to " Chinese Pharmacopoeia 2005 edition (two) " appendix IXA method, be placed in Nessler's colorimetric tube, under the fluorescent lamp visual inspection, compare clear and transparent with water, Not deeper than No. 1 turbidimetric solution.

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PUM

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Abstract

The present invention discloses a medicine composition containing taxane compound. Said medicine composition contains taxane compound with therapeutic effective dose, Tween-like surfactant and cosolvent, in which the cosolvent is selected from one kind or several kinds of glycerine of polyethylene glycol. Said medicine composition can be injection solution, also can be freeze-dried injection preparation. Said invention also discloses a method for preparing said medicine composition.

Description

technical field [0001] The invention relates to a pharmaceutical composition with taxane compounds as active ingredients, a preparation method and application of the composition. 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 cathelicidin, promote the assembly of microtubule dimers into microtubules, and cause microtubule super-stabilization and inhibit The dynamic reorganization of the microtubule network eventually stops cell proliferation at the quiescent stage of mitosis, thereby acting as a cytotoxic agent. At present, paclitaxel and docetaxel (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), head cancer, etc. Treatment of primary and metastatic cancers such as squamous cell carcinoma of the neck and malignan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/337A61K9/08A61K9/19A61P35/00
CPCA61K9/08A61K9/19A61K31/337A61K47/26A61K9/0019A61P35/00A61P35/04
Inventor 郝守祝马智勇
Owner 郝守祝
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