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Mimilactone lipid microsphere injection and preparation method thereof

A technology for lipid microspheres and injections, applied in the field of medicine, can solve problems such as poor water solubility, interference with drug effects, and inactivity of CSCs

Inactive Publication Date: 2011-11-30
ACCENDATECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In 2009, Lander et al. reported on Cell that paclitaxel, the most widely used small-molecule anti-cancer drug, can inhibit the growth of main cancer cells, but it has no activity on CSCs, resulting in an increase in the proportion of CSCs in cancer cells, which is even more severe. prone to new tumor globules
Many clinical drugs have poor water solubility and must rely on organic solvents to play a role, and organic solvents not only have certain toxicity themselves, but may also interfere with the drug effect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Prescription 1:

[0027] Soybean oil for injection 10g

[0028] Michelactone 1g

[0029] Soy Lecithin 2g

[0030] Glycerin 1g

[0031] Tween-80 1g

[0032] Add water for injection to 100ml

[0033] Preparation method 1:

[0034] (1) Disperse glycerin for injection and F68 in an appropriate amount of water for injection, add it to 60-70° during stirring and stir until completely dissolved; Add soybean oil to 60-70°C and stir until soy lecithin and migna lactone are completely dissolved; (3) Add the oil phase to the water phase and stir in a high-speed cutter for a few minutes; (4) Adjust the pH to 4 -9, dilute with water for injection to the prescribed amount, transfer to high-pressure micro-injection homogenizer 3-7; (5), seal, and sterilize in a high-pressure rotary sterilizer.

Embodiment 2

[0036] Prescription 2:

[0037] Soybean oil / MCT 15g

[0038] Michelactone 0.05g

[0039] Lecithin 1g

[0040] Glycerin 0.5g

[0041] Sodium Oleate 0.5g

[0042] Add water for injection to 100mL

[0043] Preparation method 2:

[0044] (1) Disperse glycerin for injection, sodium oleate, and F68 in an appropriate amount of water for injection, and add

[0045] Stir to 60-70□ until completely dissolved; (2) Add lecithin for injection, Tween-80, mimilactone into the mixed oil phase composed of MCT for injection and soybean oil for injection, and add to 60-70□ Stir until the lecithin and milactone are completely dissolved; (3) Add the oil phase to the water phase, and stir in a high-speed cutting machine for a few minutes, 3; (4) Adjust the pH to 4-9, dilute the volume with water for injection to the prescription The amount was transferred to the high pressure micro injection homogenizer 3-7(5), sealed, and sterilized in a high pressure rotary sterilizer.

Embodiment 3

[0047] Prescription 3:

[0048] Coix seed oil for injection 20g

[0049] Michelactone 2g

[0050] Soy Lecithin 2.5g

[0051] Glycerin 1g

[0052] Add water for injection to 100ml

[0053] Preparation method 3:

[0054](1) Mix the prescribed amount of soy lecithin and glycerin with an appropriate amount of water for injection to 60-70, and stir until completely dissolved; (2) add soy lecithin and mimilactone for injection to coix seed oil for injection, add to Stir at 60-70°C until soy lecithin and mimilactone are completely dissolved; (3) Add the oil phase to the water phase, stir in a high-speed cutter for several minutes, 3; (4) Adjust the pH to 4-9, and add water for injection Dilute the volume to the prescribed amount, transfer to high-pressure micro-injection homogenizer 3-7; (5), seal, and sterilize in high-pressure rotary sterilization.

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PUM

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Abstract

The invention relates to mimilactone lipid microsphere injection and its preparation process. The main components and proportion of the mimilactone lipid microsphere are oil phase 5-30%, mimilactone 0.01-5%, and surfactant 0.1% -5%, glycerol 0.1-5%, the rest is water for injection. Particle size range, <1μm. The mimilactone lipid microspheres of the present invention are used for cancer treatment, especially for the treatment of acute leukemia, and can be used as the first-selected drug for acute lymphoblastic leukemia and acute myelogenous leukemia; they are also useful for lymphosarcoma, neuroblastoma, rhabdomyosarcoma, etc. Obvious therapeutic effect; it can also be used in combination with other drugs.

Description

technical field [0001] The invention relates to the technical field of medicine, more precisely it relates to the preparation and formula of lipid microspheres (oil-in-water emulsion) for injection containing mimilactone. Background technique [0002] There are 10 million new cases of cancer every year in the world, 7 million deaths due to cancer, and 22 million existing patients (data source: Chinese Anti-Cancer Association in 2005). And it is increasing year by year. In the next 20 years, the number of new patients will increase from the current 10 million to 15 million per year, and the number of deaths from cancer will also increase from about 7 million to 10 million per year. In my country, there are 2.2 million new cases every year, 1.6-1.7 million deaths due to cancer, and 3.1 million existing patient cases (data source: China Anti-Cancer Association in 2005). In 2006, the number of deaths due to cancer reached 1.8 million, surpassing the death toll of cardiovascular...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K9/16A61K31/365A61P35/00
Inventor 卢亚欣陈悦张泉翟佳黛
Owner ACCENDATECH
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