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Preparation method of novel hard-soluble medicine liposome

A technology of insoluble drugs and liposomes, which is applied in liposome delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of no residue, high risk, environmental pollution, etc., and achieve particle control diameter size, stable product quality, and simple production process

Inactive Publication Date: 2009-03-18
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] 1. The organic solvent should not remain in the preparation, which leads to complex liposome preparation process, poor reproducibility and high manufacturing cost;
[0007] 2. Organic solvents are flammable and explosive, and the production risk is relatively high;
[0008] 3. The application of organic solvents will cause environmental pollution

Method used

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  • Preparation method of novel hard-soluble medicine liposome
  • Preparation method of novel hard-soluble medicine liposome
  • Preparation method of novel hard-soluble medicine liposome

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Prescription: Paclitaxel 1g

[0038] Soy Lecithin 30g

[0039] Tween 80 1g

[0040] Sodium deoxycholate 1g

[0041] Cholesterol 3g

[0042] Mannitol 60g

[0043] water 600mL

[0044] Preparation process: mix paclitaxel, Tween 80, and sodium deoxycholate uniformly to obtain mixture a; grind soybean lecithin, cholesterol and mannitol (water-soluble diluent) together until uniformly mixed to obtain mixture b; mix mixture a and b Grind until mixed uniformly to obtain mixture c, add 600mL of water for injection, and use a colloid mill for shearing and mixing; after mixing evenly, perform high-pressure homogeneous circulation to obtain a paclitaxel liposome suspension with an average particle size of 90%.

Embodiment 2

[0046] Prescription: Paclitaxel 1g

[0047] Soy Lecithin 30g

[0048] Tween 80 3g

[0049] Mannitol 60g

[0050] water 1000mL

[0051] Preparation process: Mix paclitaxel and Tween 80 evenly to obtain mixture a; grind soybean lecithin and mannitol (water-soluble diluent) together until mixed evenly, pass nitrogen protection during grinding, and keep the temperature of the material below 20°C through a condensing device , to obtain mixture b; grind mixture a and b until they are evenly mixed, pass nitrogen protection during the grinding, and keep the material temperature below 20°C through a condensing device to obtain mixture c, add 1000mL water for injection, and shear at high speed until uniformly mixed. During the cutting process, the temperature of the material was kept below 20°C by a condensing device, and nitrogen was protected; after mixing evenly, a high-pressure homogenization cycle was carried out, and then treated with a liposome extruder to obtain a paclitaxel ...

Embodiment 3

[0053] Prescription: Paclitaxel 1g

[0054] Soy Lecithin 30g

[0055] Tween 80 3g

[0056] Vitamin E 0.1g

[0057] Mannitol 60g

[0058] water 1000mL

[0059] Preparation process: Mix paclitaxel and Tween 80 evenly to obtain mixture a; grind soybean lecithin, vitamin E (antioxidant) and mannitol (water-soluble diluent) together until mixed evenly, pass nitrogen protection during the grinding, pass condensation The device keeps the temperature of the material below 20°C to obtain mixture b; grind the mixture a and b until they are evenly mixed, pass nitrogen protection during the grinding, and keep the temperature of the material below 20°C through the condensation device to obtain mixture c, add 1000mL of water for injection, high-speed Shear until the mixture is uniform. During the high-speed shearing process, the temperature of the material is kept below 20°C through the condensing device, and the nitrogen is protected; after the mixture is uniform, the high-pressure hom...

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Abstract

The invention provides a preparation method of a novel insoluble drug liposome without the application of an organic solvent in the preparation process. The invention names the method as a water soluble surfactant dispersion method. The preparation method comprises the following steps: A. an insoluble drug is dissolved or suspended or mixed in a water soluble surfactant; B. lipid substances, a water soluble diluent and the water soluble surfactant which is dissolved or suspended or mixed with the insoluble drug for forming the liposome are evenly mixed; C. the appropriate amount of water or water solution is added in the mixture which is obtained in step B, the even mixing is carried out, and the high pressure homogenization or the high pressure homogenization is carried out, thereby obtaining liposome suspension; D. other liposome components can be added by adopting the appropriate method in any step of the steps of A, B and C according to the physical and the chemical properties, if the insoluble drug liposome does not contain other liposome components, the liposome components can not be added.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, in particular it is a preparation method of a novel insoluble drug liposome. Background technique: [0002] Liposomes (liposomes, also known as lipid globules) are bilayer microvesicles that resemble biological membrane structures. In 1971, British Rymen et al began to use liposomes as drug carriers. [0003] Liposome is a particle containing phospholipid components, which can be used as a carrier for insoluble drugs and is a new type of pharmaceutical preparation. After the drug-containing liposome is administered intravenously, it is mainly swallowed by the reticuloendothelial system, so that the drug is mainly accumulated in tissues and organs such as the liver, spleen, lung and bone marrow, and the distribution of the encapsulated drug in the body is changed, thereby improving the therapeutic effect of the drug. Index, which can reduce the therapeutic dose of the drug and reduce ...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K47/34A61K47/24A61K47/26
Inventor 周建平张振海吕慧侠李悦恒施祥杰李剑张磊
Owner CHINA PHARM UNIV
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