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Docetaxel nanometer lipid injection, preparation method and purpose thereof

A nano-lipid, docetaxel technology, applied in the field of medicine, can solve the problems of hemolysis, allergy, and complicated use methods.

Active Publication Date: 2009-10-07
HAIKOU PHARMA FACTORY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the preparations used clinically at home and abroad are mainly docetaxel for injection. A large amount of solubilizer Tween-80 is used as a solvent in the preparations. Before use, it needs to be diluted with a special solvent for injection. The requirements for operators are extremely strict and the use of The method is cumbersome; a large amount of Tween contained in the preparation can easily cause adverse reactions such as hemolysis and allergy

Method used

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  • Docetaxel nanometer lipid injection, preparation method and purpose thereof
  • Docetaxel nanometer lipid injection, preparation method and purpose thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Embodiment 1, formula and preparation method of docetaxel nano lipid preparation of the present invention

example

[0059] Table 1: Typical prescription of docetaxel nano lipid preparation of the present invention

[0060] Ingredient name Weight ratio Function in formulation

[0061] Docetaxel 1 main drug

[0062] Phospholipid 10-20 Emulsifier

[0063] 1,2-Propanediol 10-20 Stabilizer, co-surfactant

[0064] Polyethylene glycol-12-hydroxystearate 40~60 emulsifier, co-stabilizer

[0065] Absolute Ethanol 10-30 Solvent

[0066] Glycerol (glycerin) 10-30 stabilizer, co-surfactant

[0067] Pretreatment of raw and auxiliary materials for each component in the above prescription → batching according to the ratio in the above prescription → high-speed stirring → filtration → excipient liquid preparation → sterile press filtration → filling → plugging → capping → labeling → Light inspection→packaging→storage after passing the inspection.

Embodiment 2

[0068] The performance detection test of the docetaxel nano-lipid preparation of embodiment 2, embodiment 1

[0069] The docetaxel nano-lipid preparation of Example 1 of the present invention is a light yellow transparent solution, which can be mixed with water for injection in any proportion, and the formed mixed solution has opalescence. Using transmission electron microscope and laser particle size analyzer to study its morphology, it shows that the particle size distribution of this product is narrow, and the nanoparticles with a particle size of 10-200nm are more than 90%, with round particle size and good dispersion; free docetaxel is analyzed by HPLC method According to the test, the drug loading of nanoparticles is greater than 98%; this product is placed in a cool and dry place for 6 months, the content change is less than 2%, and the related substances are less than 1%, which initially shows that this product has good stability; this product is compatible with infus...

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Abstract

The present invention relates to a docetaxel nanometer lipid injection. The invention also relates to a method for preparing the docetaxel nanometer lipid injection. The invention further relates to the application of the docetaxel nanometer lipid injection for preparing medicament for treating a tumor. The nanometer preparation of the invention is capable of prolonging the medicament action time, conveying the medicament with a target, reducing the administration dose under the precondition of ensuring the medicament action, alleviating or avoiding medicament toxin and side effects, improving the medicament action stability, and being benefited for the medicament storage, thus it is capable of implementing the development of the medicament which has advantages in the aspects of a high yield, automatization, large scale, low cost, convenient carry and storage, small dose and low side-effect.

Description

technical field [0001] The present invention relates to a docetaxel nano-lipid injection, a preparation method of the docetaxel nano-lipid injection of the present invention and the docetaxel nano-lipid injection of the present invention in Application in the preparation of medicines for treating tumors. The invention belongs to the technical field of medicine. Background technique [0002] According to the report of the World Health Organization, among the 5.8 billion people in the world in 1996, more than 6 million people died of cancer, accounting for nearly 12% of the total death toll. In addition, there are more than 10 million newly diagnosed cancer patients, and it is estimated that the number of cancer patients is about 40 million. The results of the national sampling survey of malignant tumor deaths during the "Eighth Five-Year Plan" period in my country also showed that the cancer mortality rate (world adjusted normalized rate) in China was 124.46 / 100,000, accoun...

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 刘悉承沙莹张志兰
Owner HAIKOU PHARMA FACTORY
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