Docetaxel combination for injection and preparation method thereof

A technology of docetaxel and composition, applied in the field of docetaxel composition for injection and preparation thereof, can solve problems such as no improvement, and achieve the effects of avoiding hidden dangers, uniform and stable quality, and low content of related substances

Active Publication Date: 2012-01-11
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] None of the existing known technologies propose improvements to the above defects

Method used

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  • Docetaxel combination for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Weigh 100 g of docetaxel, 2.675 kg of polysorbate 80, and 5.850 kg of absolute ethanol, add the absolute ethanol into the liquid preparation tank, add the docetaxel under stirring, and stir to dissolve it completely. Add polysorbate 80, continue to stir to make it completely mixed evenly, pass the mixed docetaxel solution through a 0.22 μm polytetrafluoroethylene filter to sterilize and filter, put it in a sterile room, and pack it into a vial, half stoppered, packed Put the tray in the freeze dryer, use the compressor to cool the cold trap of the back box, turn on the vacuum pump and the septum valve, and volatilize the ethanol in the product for 12 hours, press the plug, take it out of the box, and tie the mouth with an aluminum-plastic combination cover. After passing the quality inspection and packaging, the docetaxel composition for injection can be obtained.

Embodiment 2

[0053] Weigh 100g of docetaxel and 2.675kg of polysorbate 80, add polysorbate 80 into the liquid preparation tank, slowly add absolute ethanol under stirring, and detect the density of the mother liquor by a hydrometer until the density of the mother liquor is 0.890g / ml. Add the docetaxel to the mother liquor, stir to dissolve it completely and mix well. Put the completely dissolved and uniformly mixed docetaxel solution through a 0.22 μm polytetrafluoroethylene filter to sterilize and filter, put it in a sterile room, divide it into vials, stopper halfway, put it in a plate, and put it in a freeze dryer. The oven temperature was 8.0°C and the temperature was maintained for 50 minutes. Use the compressor to refrigerate the rear box cold trap, and keep the temperature of the rear box cold trap at -58 ~ -62 °C. Turn on the vacuum pump and septum valve, control the vacuum degree of the front box at 80-100Pa, set the temperature of the front box at 8.5°C, and keep the temperatu...

Embodiment 3

[0055] Weigh 100g of docetaxel and 2.675kg of polysorbate 80, add polysorbate 80 to the liquid preparation tank, slowly add absolute ethanol under stirring, and detect the density of the mother liquor by a hydrometer until the density of the mother liquor is 0.896g / ml. Add the docetaxel to the mother liquor, stir to dissolve it completely and mix well. Put the completely dissolved and uniformly mixed docetaxel solution through a 0.22 μm polytetrafluoroethylene filter to sterilize and filter, put it in a sterile room, divide it into vials, stopper halfway, put it in a plate, and put it in a freeze dryer. The oven temperature was 8.5°C and the temperature was maintained for 50 minutes. Use the compressor to refrigerate the rear box cold trap, and keep the temperature of the rear box cold trap at -58 ~ -62 °C. Turn on the vacuum pump and the septum valve, control the vacuum degree of the front box at 80-100Pa, set the temperature of the front box at 9.5°C, and keep the tempera...

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Abstract

The invention relates to a Docetaxel combination for injection, which comprises the following components by mass ratio: 1 part of Docetaxel and 26.75 parts of polysorbate 80, wherein absolute alcohol is used as solvent in the preparation. The preparation method thereof comprises the following steps: 1) preparing mother liquid: adding polysorbate 80 to a liquid preparation tank and slowly adding absolute alcohol while stirring until the density of the mother liquid reaches 0.886g / ml to 0.896g / ml according to a hydrometer; 2) dissolving Docetaxel in the mother liquid; 3) carrying out sterile filtration, split-charging and partially stoppering; and 4) vacuum-drying, removing alcohol, stoppering, decrating and tying by aluminum-plastic composite covers stage by stage, and packaging upon qualification to obtain the Docetaxel combination for injection.

Description

technical field [0001] The invention relates to a docetaxel composition for injection and a preparation method thereof, and the docetaxel composition prepared by the method can be used for the treatment of non-small cell lung cancer. Background technique [0002] Docetaxel is a semi-synthetic paclitaxel derivative developed by Rhone-Poulenc Rorer. It is a microtubule depolymerization inhibitor that promotes the polymerization of tubules into stable microtubules. And inhibit its depolymerization so that the number of free tubules is significantly reduced. It was launched in Mexico for the first time in April 1995, and was subsequently launched in major countries such as the United Kingdom, the United States, France, Italy, Germany, and Japan. It is used for advanced and metastatic breast cancer that has failed or recurred after anthracycline antineoplastic drugs and non-small cell lung cancer that has not responded to treatment. The recommended dosing regimen is once every ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/337A61K9/08A61P35/00
CPCA61K9/19A61K31/337A61P35/00
Inventor 陈庆财赵俊赵小伟戴建国叶东戴艳
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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