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Pharmaceutical composition of docetaxel injection

A docetaxel injection technology, applied in the drug combination field of docetaxel injection, to achieve good dilution and solubility effects

Pending Publication Date: 2022-02-15
SHIJIAZHUANG UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Except that paclitaxel liposome and paclitaxel albumin are made into preparations by encapsulation, there is no pharmaceutical preparation made by conventional preparation methods so far

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Docetaxel 10g HS 400g anhydrous ethanol 400ml polyethylene glycol 200 200ml citric acid 1g anhydrous ethanol Make up to 1000ml

[0040] Dissolve docetaxel in ethanol, add HS, citric acid and polyethylene glycol in sequence, shake and mix to obtain a transparent slightly viscous solution, filter and sterilize, add it to a sterile bottle, and seal it. This product does not need to be used before use. Dilute it again and use it directly with 0.9% normal saline or 5% glucose.

Embodiment 2

[0042] Docetaxel 10g HS 350g anhydrous ethanol 450ml polyethylene glycol 200 200ml citric acid 2g anhydrous ethanol Make up to 1000ml

[0043] Dissolve docetaxel in ethanol, add HS, citric acid and polyethylene glycol in sequence, shake and mix to obtain a transparent slightly viscous solution, filter and sterilize, add it to a sterile bottle, and seal it. This product does not need to be used before use. Dilute it again and use it directly with 0.9% normal saline or 5% glucose.

Embodiment 3

[0045] Chemical stability of docetaxel in preparations The injection composed of drug, solubilizer, dissolving agent, dispersing agent and stabilizer was heated at 100 degrees to observe the stability of the drug. The effect of the different composition of the obtained on the stability of the drug is shown in the following table, citric acid and polyethylene glycol have the effect of stabilizing the drug. Citric acid and polyethylene glycol complexes are preferred as stabilizers.

[0046] Attached table: Chemical stability of docetaxel (content change %)

[0047] prescription composition before heating after heating Docetaxel + HS 100 80.2 Docetaxel + Ethanol 100 39.7 Docetaxel + Ethanol + HS + Macrogol 200 100 99.8 Docetaxel + Ethanol + HS + Propylene Glycol 100 97.2 Docetaxel+ethanol+HS+citric acid 100 99.2 Docetaxel+ethanol+HS+polyethylene glycol 200+citric acid 100 99.9

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PUM

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Abstract

The invention relates to a pharmaceutical composition of a docetaxel injection, and belongs to the technical field of pharmaceutical preparations. The pharmaceutical composition of the docetaxel injection comprises a medicine, a solubilizer, a solvent, a dispersing agent and a stabilizing agent, wherein the medicine is docetaxel, and the solubilizer is Solutol HS 15 (HS). According to the technical scheme, the novel docetaxel injection is prepared, and the docetaxel injection is good in stability, free of toxicity and free of anaphylaxis.

Description

technical field [0001] The invention relates to a pharmaceutical combination of docetaxel injection, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Docetaxel is a first-line drug for the treatment of various tumors, such as non-small cell lung cancer, breast cancer, gastric cancer, prostate cancer, and head and neck tumors. At present, Docetaxel injection, like Paclitaxel injection, uses Tween 80 as a solubilizer. Tween 80 can cause allergic reactions, which can produce allergic reactions such as rash, headache, dilation of blood vessels, reddening of the skin, bronchospasm. In order to reduce side effects, anti-allergic measures such as hormones need to be given before use. In order to solve this side effect, a lot of research has been carried out at home and abroad. Except for paclitaxel liposome and paclitaxel albumin prepared by encapsulation method, there is no pharmaceutical preparation prepared by conventional pre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/337A61K47/10A61K47/12A61P35/00
CPCA61K31/337A61K9/0019A61K47/10A61K47/12A61K9/08A61P35/00
Inventor 剧慧栋周二鹏
Owner SHIJIAZHUANG UNIVERSITY
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