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Novel docetaxel injection pharmaceutical composition and application thereof

A docetaxel and drug technology, applied in the direction of drug combination, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of lack of cold distribution system, product quality impact, refrigerator storage increase, etc. Achieve the effects of simple process, less adverse reactions, convenient storage and use

Inactive Publication Date: 2012-01-11
张伟 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Domestic products can only be stored in the refrigerator (2~8℃)
Especially for domestic products, tens of thousands of hospitals need refrigerator storage to increase, causing a lot of waste
my country lacks a cold distribution system, which will also affect product quality during transportation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Preparation of agent A.

[0034] Method 1: Docetaxel 10g, absolute ethanol 100ml, stir to dissolve, filter, after testing the particle size is less than 80μm, pack into sterile bottles, then add water for injection of 100% volume of the dose (V), and dry under reduced pressure , seal the lid, and get the medicine.

[0035] Method 2: Docetaxel 10g, dehydrated ethanol 100ml, stir to dissolve, filter, after testing the particle size is less than 80μm, sub-pack into sterile bottles, then add water for injection of 100% volume of the dose (V), freeze-dry, Seal the lid and get the medicine.

[0036] Method 3: Docetaxel 10g, absolute ethanol 200ml, stir to dissolve, filter, after testing the particle size is less than 80μm, pack into sterile bottles, then add water for injection of 100% volume of the dose (V), and dry under reduced pressure Or freeze-dried, sealed, to obtain medicines.

[0037] Method 4: Docetaxel 10g, dehydrated ethanol 400ml, stir to dissolve, filter, aft...

Embodiment 2

[0044] Preparation of agent B.

[0045] Method 1: Take 1000g of Tween 80, add 400ml of absolute ethanol, stir evenly, add 0.7ml sterile bottle to each bottle, seal the cap, and sterilize at 120°C for 30 minutes. Inject the solvent.

[0046] Method 2: Take 1000g of Tween 80, add 600ml of absolute ethanol, stir evenly, add 0.8ml sterile bottle to each bottle, seal the cap, and sterilize at 120°C for 30 minutes. Inject the solvent.

[0047] Method 3: Take 1000g of Tween 80, add 1000ml of absolute ethanol, stir evenly, add 1.0ml sterile bottle to each bottle, seal the cap, and sterilize at 120°C for 30 minutes. Inject the solvent.

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Abstract

The invention discloses a novel docetaxel injection pharmaceutical composition, which comprises an A agent (micro-nano-docetaxel) and a B agent (a drug solvent). The docetaxel injection pharmaceutical composition disclosed by the invention is simple in production process and convenient to use. The docetaxel injection pharmaceutical composition can be stored at room temperature. The drug stability is prior to homemade and importation like products.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparation development. [0002] The invention relates to a new drug combination of docetaxel injection preparation, which is composed of agent A (micronano docetaxel) and agent B (vehicle). Background technique [0003] Paclitaxel (Taxol) and docetaxel (Docetaxel, Taxotere) are antineoplastic drugs that act on cell microtubules. It is currently the first-line drug for the treatment of various tumors, such as non-small cell lung cancer, esophageal cancer, liver cancer, nasopharyngeal cancer, gastric cancer, prostate cancer, and head and neck squamous cell carcinoma. [0004] Docetaxel is a derivative of paclitaxel in which benzoyl is substituted by a carbonyl group. Compared with paclitaxel, its water solubility has been significantly improved, but its chemical stability is poor. Therefore, docetaxel injections both at home and abroad use binary combinations to increase stability. Docetaxel injec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/337A61K47/34A61P35/00
Inventor 张伟杨霁初张秀国杨明
Owner 张伟
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