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Paclitaxel injection and preparation method thereof

A paclitaxel and injection technology, applied in the field of medicine, can solve problems such as inconvenient use, and achieve the effect of convenient use and pollution reduction

Active Publication Date: 2008-06-04
GUANGDONG KELUN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to prevent the occurrence of allergic reactions, at present, antihistamines such as diphenhydramine and dexamethasone are taken several hours before the infusion, which is very inconvenient to use

Method used

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  • Paclitaxel injection and preparation method thereof
  • Paclitaxel injection and preparation method thereof
  • Paclitaxel injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Take 400ml of absolute ethanol and 300ml of normal saline and stir, then add 400-300ml of polyethylene glycol, and stir evenly; then, add 8040g of Tween, stir evenly, add 0.25g of activated carbon for needles, heat at 35°C for adsorption, coarse filter to remove carbon, pH The value is 3, filtered with 0.22μm microporous membrane, potted, sterilized at 115°C for 30min, as the solvent; the glass infusion bottle was washed with potassium dichromate sulfuric acid solution, dried at 260°C for 25min, and butyl rubber Stopper for sterilization; take 3 g of paclitaxel and add it to dissolve in the solvent, sterilize and filter, pour into a glass infusion bottle and seal it under aseptic purification conditions, and make a paclitaxel injection containing 150 mg of paclitaxel per 50 ml.

Embodiment 2

[0025] Take 400ml of absolute ethanol and 300ml of normal saline and stir, then add 400-300ml of polyethylene glycol, and stir evenly; then, add 8030g of Tween, stir evenly, add 0.3g of activated carbon for needles, heat at 40°C for adsorption, coarse filter to remove carbon, pH The value is 5, filtered with 0.3μm microporous membrane, potted, sterilized at 125°C for 20min, as the solvent; after cleaning the glass infusion bottle with potassium dichromate sulfuric acid solution, dried at 230°C for 35min, butyl rubber Stopper for sterilization; take 2 g of paclitaxel and add it to dissolve in the solvent, sterilize and filter, pour it into a glass infusion bottle and seal it under aseptic purification conditions, and prepare the paclitaxel injection containing 100 mg of paclitaxel per 50 ml.

Embodiment 3

[0027] Take 300ml of absolute ethanol and 400ml of normal saline and stir, then add 400-300ml of polyethylene glycol, and stir evenly; then, add 8020g of Tween, stir evenly, add 0.5g of activated carbon for needles, heat at 40°C for adsorption, coarse filter to remove carbon, pH The value is 5, filtered with 0.4μm microporous membrane, potted, sterilized at 100°C for 35min, as the solvent; the glass infusion bottle is washed with potassium dichromate sulfuric acid solution, dried at 250°C for 30min, and butyl rubber Stopper for sterilization; take paclitaxel 0.6g and add it to dissolve in solvent, sterilize and filter, pour into a glass infusion bottle and seal under aseptic purification conditions, and make paclitaxel injection containing 30mg paclitaxel per 50ml.

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Abstract

The invention relates to a paclitaxel injection and a preparation method of the injection: (1) 200 to 400ml of absolute alcohol and 200 to 400ml of normal saline are taken to be stirred, and 150 to 400ml of polyethylene glycol 400 is added to be evenly mixed; (2) 20 to 40g of tween-80 is added in to the mixture of (1) to be evenly mixed, and then 0.2 to 0.5g of active carbon used for injection is added to be heated by 35 to 40 DEG C, and raw filtering is carried out and the PH value is controlled to be between 3 to 5; filtering is done and filling and sealing process is carried out; sterilization is carried out for 20 to 35 minutes at the temperature of 100 to 125 DEG C; (3) a transfusion bottle is washed and then is dried for 25 to 35 minutes the temperature of 230 to 260 DEG C, and butyl rubber plug is sterilized; (4) 0.6 to 3g of paclitaxel is taken to be added into the mixture of (2) for dissolving, and then sterilization and filtering are done; and then the solution is filled into the transfusion bottle in the sterilized environment; finally, the bottle is sealed to get the finished product. The invention can prepare safe and reliable paclitaxel injection, by adopting the method of preparing menstruum firstly and paclitaxel solution secondly, the quality of the injection is guaranteed.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a paclitaxel injection and a preparation method thereof. Background technique [0002] Paclitaxel is an antineoplastic drug extracted from Taxus chinensis. It has a unique mechanism of action, by inducing and promoting tubulin polymerization, assembly and stabilizing microtubules, preventing the growth of tumor cells, and has curative effects on ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer and prostate cancer Significantly, it is a broad-spectrum anticancer drug. It was listed in the United States in 1993 and approved for listing in my country in 1995. Paclitaxel is considered to be one of the most effective anti-cancer drugs discovered so far, and it is also the best-selling anti-tumor drug in the world. [0003] Paclitaxel is soluble in methanol, ethanol or chloroform, almost insoluble in water, the solubility in water is only 0.006mg / ml, and the ef...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/337A61K9/08A61K47/34A61P35/00A61K47/26
Inventor 张京维熊国运
Owner GUANGDONG KELUN PHARMACEUTICAL CO LTD
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