Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Medicine composition containing docetaxel and preparation method thereof

A docetaxel and composition technology, applied in the field of detail problem handling and improvement, can solve problems such as difficult dispersion, increased dissolution time of docetaxel and related additives, unfavorable stability of docetaxel injection, etc., to achieve High accuracy of dispensing, reduced risk of foreign microbial contamination, and short dissolution and dispersion time

Inactive Publication Date: 2010-05-19
ZHEJIANG WAN SHENG PHARMA CO LTD
View PDF2 Cites 5 Cited by
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • 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] Example 1 Refining of Polysorbate 80

[0020] Take 750g of polysorbate 80 and add it to a 2000ml clean and dry three-necked flask with ultrasonic device and mechanical stirring. Add 3.8g of lactic acid and mix well, adjust the pH to 3.56, add 7.5g of activated medicinal charcoal, and heat to 60 in a water bath After stirring for 30 min at ℃±2℃, the pH value was measured to be 3.63, and the refined polysorbate 80 was obtained by filtering while hot with a 0.22um microporous membrane.

Embodiment 2

[0021] Example 2. Preparation of a 60mg strength docetaxel injection

[0022] Place 10 grams of docetaxel in a clean and dry 1000mL three-necked flask with ultrasonic device and mechanical stirring, add 10 grams of absolute ethanol, add 30 grams of refined polysorbate 80, and ultrasonically shake until the docetaxel is completely dissolved. Ultrasonic vibration, 30-40℃, 2KPa pressure for 30 minutes, add 300 grams of refined polysorbate 80, start mechanical stirring, pass nitrogen protection, continue to stir for two hours, sterilize and filter with 0.22um microporous membrane, press 60mg of the main drug in each bottle is obtained after dispensing, stoppering and capping.

Embodiment 3

[0023] Example 3. Preparation of 80mg Docetaxel Injection

[0024] Place 40 grams of docetaxel in a clean and dry 2000mL three-necked flask equipped with ultrasonic equipment and mechanical stirring, add 50 grams of absolute ethanol, add 60 grams of refined polysorbate 80, and ultrasonically shake until the docetaxel is completely dissolved. Ultrasonic vibration, 30-40℃, 5KPa pressure for 30 minutes, add 1200 grams of refined polysorbate 80, start mechanical stirring, pass nitrogen protection, continue to stir for two hours, sterilize and filter with 0.22um microporous membrane, press 80mg of the main drug in each bottle is divided into, stoppered, and capped.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

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 detailed problems in the production process. Background technique [0002] Docetaxel is a therapeutic drug with broad-spectrum anti-tumor activity, chemical name: [2aR-(2aα, 4β, 4aβ, 6β, 9α, (aR, βS), 11α, 12α, 12aα, 12bα)] -β-[[(1,1-Dimethylethoxy)carbonyl]amino]-α-hydroxyphenylpropionic 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- Methyl-1H-cyclodecpentaeno[3,4]benzo[1,2-b]oxabutan-9-yl] ester trihydrate, its structural formula is as follows: [0003] [0004] Docetaxel is a paclitaxel anti-tumor drug. It was first marketed in Mexico in April 1995, and was then listed in major developed countries such as Britain, the United States, France, Italy, Germany, and Japan. Its pharmacological effect is to play an ant...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(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
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com