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Medicine composition containing docetaxel and preparation method thereof

A docetaxel and composition technology, which is applied in the field of processing and improvement of detailed problems, can solve the problems of increasing the dissolution time of docetaxel and related additives, unfavorable stability of docetaxel injection, and difficulty in dispersion, etc. The effect of reducing the risk of foreign microbial contamination, short dissolution and dispersion time, and high dispensing accuracy

Inactive Publication Date: 2012-09-05
ZHEJIANG WAN SHENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tartaric acid, citric acid or ascorbic acid are all solid organic acids, which are not easy to disperse in viscous liquid medicine, which increases the dissolution time of docetaxel and related additives, which is unfavorable for the stability of docetaxel injection

Method used

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  • Medicine composition containing docetaxel and preparation method thereof
  • Medicine composition containing docetaxel and preparation method thereof
  • Medicine composition containing docetaxel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The refining of embodiment 1 polysorbate 80

[0020] Take 750g of polysorbate 80 and add it to a 2000ml clean and dry three-neck flask equipped with an ultrasonic device and mechanical stirring, add 3.8g of lactic acid and mix evenly, adjust the pH to 3.56, add 7.5g of activated medicinal charcoal, and heat it in a water bath to 60 ℃±2℃, after stirring for 30 minutes, check the pH value to 3.63, and filter while hot with a 0.22um microporous membrane to obtain refined polysorbate 80.

Embodiment 2

[0021] Embodiment 2, the preparation of a kind of 60mg specification docetaxel injection

[0022] Put 10 grams of docetaxel in a clean and dry 1000 mL three-neck flask equipped with an ultrasonic device and mechanical stirring, add 10 grams of absolute ethanol, add 30 grams of refined polysorbate 80, and ultrasonically oscillate until the docetaxel is completely dissolved. Ultrasonic oscillation, 30-40°C, and 2KPa pressure for 30 minutes, add 300 grams of refined polysorbate 80, start mechanical stirring, nitrogen protection, continue stirring for two hours, use 0.22um microporous filter membrane to sterilize and filter, press Each bottle of 60mg of the main drug can be obtained after sub-packaging, stoppering and capping.

Embodiment 3

[0023] Embodiment 3, the preparation of a kind of 80mg specification docetaxel injection

[0024] Put 40 grams of docetaxel in a clean and dry 2000 mL three-necked flask equipped with an ultrasonic device and mechanical stirring, add 50 grams of absolute ethanol, add 60 grams of refined polysorbate 80, and ultrasonically oscillate until the docetaxel is completely dissolved. Ultrasonic oscillation, 30-40°C, and 5KPa pressure for 30 minutes, add 1200 grams of refined polysorbate 80, start mechanical stirring, nitrogen protection, continue stirring for two hours, use 0.22um microporous filter membrane to sterilize and filter, press Each bottle of 80mg of the main drug can be obtained after sub-packaging, stoppering and capping.

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Abstract

The invention relates to a medicine composition containing docetaxel and a preparation method thereof. The medicine composition is characterized by comprising the following components according to the mixture ratio (in parts by weight): 10-100 parts of docetaxel, 260-2600 parts of polysorbate 80, 1-20 parts of stabilizing agent and 0-11 parts of anhydrous alcohol; The preparation method comprises the following steps: (1) adding the stabilizing agent which regulates the pH into the polysorbate 80, dispersing, dissolving and adding medicinal carbon for refining the polysorbate 80; (2) taking part of the refined polysorbate 80, adding the docetaxel and the anhydrous alcohol, dissolving the medicine by the dissolution-aiding means of ultrasonic, stirring and the like and stirring the mixture evenly; (3) after removing the anhydrous alcohol, adding the remanent refined polysorbate 80, stirring and mixing the mixture evenly; and (4) after sterilizing and filtering, filling the obtained solution into a sterile container by filling equipment.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing docetaxel and a preparation method thereof, in particular to the treatment and improvement of the details in the production process. Background technique [0002] Docetaxel is a therapeutic drug with broad-spectrum anti-tumor activity. )]-β-[[(1,1-dimethylethoxy)carbonyl]amino]-α-hydroxyphenylpropanoic acid [12b-acetoxy-12-benzoyloxy-2a,3,4,4a , 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4, 6, 11-trihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7, 11 -Methylene-1H-cyclodecapenta[3,4]benzo[1,2-b]oxetan-9-yl]ester trihydrate, its structural formula is as follows: [0003] [0004] Docetaxel is a paclitaxel antineoplastic drug, which was first launched in Mexico in April 1995, and was immediately launched in major developed countries such as the United Kingdom, the United States, France, Italy, Germany, and Japan. Its pharmacological effect is to play an anti-tumor effect by interfering with ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/337A61K47/12A61P35/00
Inventor 王永军黄法樊榕俞淑霞张根山
Owner ZHEJIANG WAN SHENG PHARMA CO LTD
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