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Docetaxel injection composition and preparation method thereof

A technology of docetaxel and injection, applied in the direction of drug combination, pharmaceutical formula, drug delivery, etc., can solve the problems of transportation, production and storage, and inconvenient use, and achieve the effect of enhancing safety and stability

Active Publication Date: 2013-03-27
哈药集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Product transportation, storage and use are very inconvenient

Method used

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  • Docetaxel injection composition and preparation method thereof
  • Docetaxel injection composition and preparation method thereof
  • Docetaxel injection composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0074] Add 20g of docetaxel and 500ml of absolute ethanol into the container, stir well (stirring frequency 1200-1500rpm, stirring time 15min) until dissolved, add 0.1% activated carbon for needles (w / v), and stir for 5 minutes; 0.45um membrane decarburization. Add 500ml polyethylene glycol stearate 15 and mix for 10 minutes. Add anhydrous citric acid to adjust the pH value to 3.4-4.1, add absolute ethanol to 1000ml, and stir for 10 minutes. Filling, ethanol removal (freeze dryer is used as ethanol removal equipment, the temperature is at 35°C, and the vacuuming time is more than 21 hours), buckle and cap. Put it in a rotary water bath sterilizer, and sterilize it at 126°C for 4 minutes (verified sterilization F 0 Value greater than 12, for the overkill method) to obtain.

Embodiment 2

[0076] Add 20g of docetaxel and 500ml of absolute ethanol into the container, stir well (stirring frequency 1200-1500rpm, stirring time 15min) until dissolved, add 0.1% activated carbon for needles (w / v), and stir for 5 minutes; 0.45um membrane decarburization. Add polyethylene glycol stearate 15 250ml and mix for 10 minutes. Add anhydrous citric acid to adjust the pH value to 3.4-4.1, add absolute ethanol to 1000ml, and stir for 10 minutes. Filling, ethanol removal (freeze dryer is used as ethanol removal equipment, the temperature is at 35°C, and the vacuuming time is more than 21 hours), buckle and cap. Put it in a rotary water bath sterilizer, and sterilize it at 126°C for 4 minutes (verified sterilization F 0 Value greater than 12, for the overkill method) to obtain.

Embodiment 3

[0078] Add 40g of docetaxel and 500ml of absolute ethanol into the container, stir well until dissolved, add 0.1% activated carbon for needles (w / v), and stir for 5 minutes; 0.45um membrane decarburization. Add 540ml polyethylene glycol stearate 15 and mix for 10 minutes. Add anhydrous citric acid to adjust the pH value to 3.4-4.1, add absolute ethanol to 1000ml, and stir for 10 minutes. Filling, ethanol removal, corking and capping. Put it in a rotary water bath sterilizer, and sterilize it at 126°C for 4 minutes (verified sterilization F 0 Value greater than 12, for the overkill method) to obtain.

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PUM

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Abstract

The invention provides a docetaxel injection composition and preparation method thereof. The components of the docetaxel injection are as follows: the concentration of a main drug docetaxel ranges from 20 mg / mL to 60 mg / mL; the proportional range of the main drug to absolute ethyl alcohol is 1 : 1-1 : 50; the proportion of the main drug to poly(ethylene glycol stearate) 15 ranges from 1 : 1 to 1 : 50; anhydrous citric acid is used as a pH conditioning agent; and the pH range adjusted by anhydrous citric acid is from 3 to 4.5.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a safe and stable docetaxel injection composition and a preparation method thereof. Background technique [0002] Docetaxel (English name Docetaxel), the chemical name is: [2aR-[2aα,4β,4aβ,6β,9α,(αR',βS'),11α,12α,12aα,12bα)]-β-[[ (1,1-Dimethylethoxy)carbonyl]amino]-α-carbonylphenylpropanoic 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- Cyclodepenta[3,4]benzo[1,2-b]oxetan-9-yl]ester. Chemical Structure: [0003] [0004] Docetaxel is a paclitaxel anti-tumor drug, which plays an anti-tumor effect by interfering with the microtubule network necessary for cell mitosis and interphase cell functions. Docetaxel can bind to free tubulin, promote the assembly of tubulin into stable microtubules, and at the same time inhibit its depolymerization, resulting in t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/337A61K47/34A61P35/00
Inventor 袁淑杰王丽娜苏宏健王忠李郑武崔琳马赛高晶宋紫玉曹翊婕
Owner 哈药集团股份有限公司
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