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Taxane drug albumin nanoparticle freeze-drying preparation for injection and preparation method

A technology of albumin nanoparticles and taxanes, applied in the field of pharmaceutical preparations, to achieve good dispersion, good application prospects, and good biocompatibility

Inactive Publication Date: 2015-11-04
JILIN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to overcome the existing albumin nano-preparation process to add too many toxic chemical cross-linking agents, resulting in nano-preparation toxicity and poor biocompatibility Poor defect, providing a preparation method of taxane drug albumin nanoparticle lyophilized preparation for injection

Method used

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  • Taxane drug albumin nanoparticle freeze-drying preparation for injection and preparation method
  • Taxane drug albumin nanoparticle freeze-drying preparation for injection and preparation method
  • Taxane drug albumin nanoparticle freeze-drying preparation for injection and preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Example 1 . Preparation of paclitaxel albumin nano-lyophilized preparation.

[0033] (1) Take 20ml of pre-prepared 0.5% potassium chloride solution, mix it with 8ml of human serum albumin, and place them together in a 50°C water bath for incubation as the water phase.

[0034] (2) Accurately weigh 200mg of paclitaxel and dissolve in 10ml of ethanol at a concentration of 20mg / ml as the oil phase.

[0035] (3) Use a peristaltic pump to incubate the water phase in step (1) and keep it at 50°C through a heat exchanger. At the same time, the oil phase in step (2) is also under the action of the peristaltic pump, and the water phase: oil phase pump speed = 2.5 The ratio of :1 enters the three-way structure of the microfluidic device at the same time, and the mixed liquid is rapidly cooled to 0-10°C at the outlet of the three-way.

[0036] (4) Concentrate the solution obtained in step (3) by using a hollow fiber module, add 1000mg of mannitol, and filter through a 0.22um ...

Embodiment 2

[0037] Example 2 . Preparation of paclitaxel albumin nano-lyophilized preparation.

[0038] (1) Take 20ml of pre-prepared 5% potassium chloride solution, mix it with 8ml of human serum albumin, and place them together in a 50°C water bath for incubation as the water phase.

[0039] (2) Accurately weigh 300mg of paclitaxel and dissolve it in 10ml of ethanol at a concentration of 30mg / ml as the oil phase.

[0040] (3) Use a peristaltic pump to incubate the water phase in step (1) and keep it at 70°C through a heat exchanger. At the same time, the oil phase in step (2) is also under the action of the peristaltic pump, and the water phase: oil phase pump speed = 2.5 The ratio of :1 enters the three-way structure of the microfluidic device at the same time, and the mixed liquid is rapidly cooled to 0-10°C at the outlet of the three-way.

[0041] (4) Concentrate the solution obtained in step (3) by using a hollow fiber module, add 1000mg of mannitol, and filter through a 0.22um...

Embodiment 3

[0042] Example 3 . Preparation of docetaxel albumin nano-lyophilized preparation.

[0043] (1) Take 20ml of pre-prepared 15% potassium chloride solution, mix it with 12ml of human serum albumin, and place them together in a 50°C water bath for incubation as the water phase.

[0044] (2) Accurately weigh 300mg of docetaxel and dissolve it in 10ml of ethanol at a concentration of 30mg / ml as the oil phase.

[0045] (3) Use a peristaltic pump to incubate the water phase in step (1) and keep it at 70°C through a heat exchanger. At the same time, the oil phase in step (2) is also under the action of the peristaltic pump, and the water phase: oil phase pump speed = 3 The ratio of :1 enters the three-way structure of the microfluidic device at the same time, and the mixed liquid is rapidly cooled to 0-10°C at the outlet of the three-way.

[0046] (4) Concentrate the solution obtained in step (3) by using a hollow fiber module, add 1000mg of mannitol, and filter through a 0.22um mic...

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Abstract

The invention discloses a taxane drug albumin nanoparticle freeze-drying preparation for injection and a preparation method. According to the invention, based on physical factors, albumin is heated to a certain temperature to expand the spatial structure of albumin, and then is uniformly mixed with taxane drugs, and then the mixture is quickly cooled through physical factors; the taxane drug is coated or adsorbed to the inside or the surface of the albumin, so as to prepare the soluble taxane drug albumin nanoparticle preparation. During the preparation of the soluble taxane drug albumin nanoparticle preparation, toxic chemical crosslinking agents are not added, so that the prepared soluble taxane drug albumin nanoparticle preparation can reduce the stimulation to vessels of patients during injection and weaken the pain of patients during the use; besides, damage to the organism, caused by toxic residues released by the cross-linking agents in vivo is avoided; according to the invention, more and more taxane drugs are passively accumulated at tumor tissues in a targeting manner, so that the safety and stability of the taxane drug are improved, the action time of the drug is prolonged, and toxic and side effects of the drug are weakened.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a preparation method of a taxane drug albumin nanoparticle freeze-dried preparation for injection. Background technique: [0002] Malignant tumors are a serious threat to human health, and the incidence has risen sharply in recent years. Its treatment is difficult, and its mortality rate is second only to cardiovascular and cerebrovascular diseases. It has become a serious social problem. Although various chemotherapeutic drugs are constantly emerging, they are all accompanied by severe immune system suppression and relatively large toxic and side effects. It is difficult to improve the survival rate and quality of life of patients; [0003] Taxanes have high anti-tumor activity. By strengthening tubulin polymerization and inhibiting tubulin depolymerization, they form stable non-functional microtubule bundles, thereby inhibiting cell mitosis and proliferation. Howev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/337A61K47/42A61P35/00
Inventor 滕乐生孙亚厅曲娜谢晶滕利荣逯家辉刘艳
Owner JILIN UNIV
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