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Nanometer lipid emulsion

A fat emulsion and nanotechnology, applied in the field of medicine, can solve problems such as drug degradation, limitation of cleaning operation methods, improper preparation, etc., and achieve the effects of being conducive to safe consumption, observation and judgment, and excellent stability.

Inactive Publication Date: 2017-12-08
FUBICHENG SHANGHAI PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, emulsification usually needs to be greater than 3200kgf / cm 2 It is carried out under the pressure, which belongs to the ultra-high pressure of high-pressure jet homogenizer or special emulsifier. In order to carry out emulsification on an industrial scale under this ultra-high pressure, the emulsification equipment used repeatedly must be tough metal, Equipment costs are higher
Furthermore, from the perspective of preventing pollution in the preparation process, the cleaning operation method of the production equipment has relatively strict restrictions, requiring the emulsifier to completely clean all places that come into contact with the emulsifier, such as high-pressure jet homogenizers under ultra-high pressure It is difficult to completely clean the injection port of the device for emulsification injection
Also at 3000kgf / cm 2 Emulsification under the above pressure will increase the temperature of the emulsion. Even if the emulsified emulsifier is directly cooled, the drug in the emulsion may be degraded due to high temperature in a short period of time.
Usually, it is advisable to divide the emulsification into countless cycles to reduce the average particle size distribution range of fat particles by increasing the number of times of emulsification, but in the case of ultra-high pressure, repeated emulsification, the drug may be was sharply degraded
In addition, the fat emulsion containing drugs is different from the fat emulsion used as an infusion preparation. The fat emulsion used for injections, eye drops, nasal sprays, and inhalants is usually small in volume. If the formulation design is carried out in a container with a large capacity, if the ingredients cannot be properly allocated, it will cause improper formulation and have a direct adverse effect on the stability of the formulation (such as the separation of emulsifiers, drug coagulation, and precipitation)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1: A kind of fat emulsion (injection) containing docetaxel, docetaxel 100mg, refined soybean oil 30mg, refined egg yolk lecithin 2.5g, oleic acid 310mg, propylene glycol 3.15g are fully stirred and mixed under the condition of 55 ℃ to form oily phase. Add 125mL of purified water gradually to the above oil phase, and then carry out primary emulsification at 12000rmp for 12 minutes. Then add purified water, add the volume of the liquid to 150mL, mix, and use a high-pressure homogenizer to set the emulsification pressure at 800kgf / cm 2 , and then circulate emulsification 20 times. After emulsification, add 0.1N pH regulator hydrochloric acid aqueous solution to adjust the pH to 6.0, put the nano fat emulsion into a glass ampoule, and perform high-pressure steam sterilization at 121°C for 12 minutes, that is, the fat of docetaxel emulsion.

Embodiment 2

[0036] Example 2: A fat emulsion (injection) containing docetaxel, 100 mg of docetaxel, 30 mg of refined soybean oil, 2.5 g of refined egg yolk lecithin, 310 mg of oleic acid, and 3.15 g of propylene glycol were fully stirred and mixed at 55° C. oily phase. The above oil phase was gradually added with 125 mL of purified water containing 12 g of inositol, and then the primary emulsification was carried out at a rotation speed of 12000 rpm for 12 minutes. Then add purified water, add the volume of the liquid to 150mL, mix, and use a high-pressure homogenizer to set the emulsification pressure at 800kgf / cm 2 , and then circulate emulsification 20 times. After emulsification, add 0.1N pH regulator hydrochloric acid aqueous solution to adjust the pH to 6.0, put the nano fat emulsion into a glass ampoule, and perform high-pressure steam sterilization at 121°C for 12 minutes, that is, the fat of docetaxel emulsion.

Embodiment 3

[0037] Example 3: A fat emulsion injection containing indomethacin, 80mg of indomethacin, 90mg of refined soybean oil, 2g of refined egg yolk lecithin, 250mg of oleic acid, and 3.15g of propylene glycol were fully stirred and mixed at 55°C to form an oil Mutually. Add 125mL of purified water gradually to the above oil phase, and then carry out primary emulsification at 12000rmp for 12 minutes. Then add purified water, add the volume of the liquid to 150mL, mix, and use a high-pressure homogenizer to set the emulsification pressure at 850kgf / cm 2 , and then circulate emulsification 20 times. After emulsification, add 0.1N pH regulator hydrochloric acid aqueous solution to adjust the pH to 6.0, put the nano-fat emulsion into a glass ampoule, and perform high-pressure steam sterilization at 121°C for 15 minutes to obtain indomethacin. fat emulsion.

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Abstract

The invention relates to a nanometer lipid emulsion which comprises a drug, oil, an emulgator and water, wherein the solubility of the drug is 0-0.0005g / ml and the drug is difficult to dissolve in water. The emulsion is clear and is capable of reducing the drug degradation and the emulsion droplet agglutination caused by ultrahigh pressure and high temperature. The drug is capable of being stably packed in the emulsion droplet, so that the toxic or side effect of the drug is reduced.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a nano fat emulsion. Background technique [0002] Fat emulsion is a preparation with membrane affinity and permeability, and it is also a drug delivery carrier. Generally, the insoluble drug is dissolved in some oily solvent as the oil phase, and the water phase and the oil phase form a fat emulsion under the action of appropriate auxiliary materials through special milk homogenization process conditions. When the drug is wrapped into the fat emulsion When in emulsion droplets, it not only reduces the toxic and side effects of the drug, improves the bioavailability of the drug, but also has a certain degree of long-acting sustained release and targeting effect. In addition, fat emulsion is also an energy supplement medicine, which is a component of intravenous nutrition. It provides energy and essential fatty acids for the body. It is used to supplement energy and essential fa...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/44
CPCA61K9/1075A61K47/44
Inventor 甘莉曹亮张红芹
Owner FUBICHENG SHANGHAI PHARMA TECH CO LTD
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