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Equipment and preparation method for preparing lipid microspheres

A technology of lipid microspheres and lecithin, which is applied to the equipment and preparation of lipid microspheres, and the field of preparation of lipid microspheres, which can solve the problems of surface floating oil phase separation and insufficient colostrumization, etc.

Active Publication Date: 2020-03-17
本溪恒康制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The above prior art does not disclose the specific content and related equipment of mixing the oil phase and the water phase. In the process of mixing the oil phase and the water phase to prepare colostrum, insufficient colostrum is prone to occur, and surface Phase separation of floating oil

Method used

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  • Equipment and preparation method for preparing lipid microspheres
  • Equipment and preparation method for preparing lipid microspheres
  • Equipment and preparation method for preparing lipid microspheres

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Water phase composition: water 103kg, glycerin 2.65kg; Oil phase composition: alprostadil 0.72g, refined soybean oil 12kg, refined egg yolk lecithin PC-98T 2.16kg, oleic acid 288g; pH regulator: 10% (g / ml ) sodium hydroxide solution to adjust the pH value to 5.2-5.8.

[0040] (1) Water phase preparation: add 80% water for injection into the water phase tank, control the water temperature at 65-75°C, add glycerin under nitrogen filling conditions, stir to dissolve, and set aside;

[0041] (2) Oil phase preparation: under the condition of nitrogen filling in the oil phase tank, heat alprostadil, soybean oil, refined egg yolk lecithin, oleic acid to 60--70°C, shear and stir until the solution is clear;

[0042] (3) Primary emulsification: slowly add the oil phase to the water phase, and emulsify in the water phase tank through the high-speed shear emulsification head for 25-35 minutes, and the high-speed shear emulsification head is set on the tank body through the fixed s...

Embodiment 2

[0044] Raw material composition, step 1, step 2 are identical with embodiment 1.

[0045](3) Primary emulsification: Under the condition of nitrogen filling, the oil phase and the water phase are passed through the three-stage online disperser (with a speed of 2000-3000rpm) according to the volume ratio of 1:4, and then flow back into the water phase tank, and the three-stage online dispersion The machine circulates and shears 3-5 times. After the circular shearing, the liquid is stored in the water phase tank and continues to be emulsified for 25-35 minutes. 2000-3000rpm, add water for injection to the full amount, and add an appropriate amount of 10% (g / ml) sodium hydroxide solution to adjust the pH value of the solution, and stir to obtain colostrum.

Embodiment 3

[0047] Raw material composition, step 1, step 2 are identical with embodiment 1.

[0048] (3) Primary emulsification: Under the condition of nitrogen filling, the oil phase and the water phase are sheared by a three-stage online disperser (rotating speed: 2000-3000rpm) according to the volume ratio of 1:4, and then flowed back into the water phase tank. The online disperser cuts 3-5 times in a cycle; the three-stage online disperser turns on the high-speed shear emulsification head at the same time during the cycle shear process. 2000-3000rpm; the liquid after cyclic shearing is stored in the water phase tank and continues to emulsify for 25-35 minutes, the shearing speed is 2000-3000rpm, add water for injection to the full amount and add an appropriate amount of 10% (g / ml) hydroxide Sodium solution adjusts the pH value of the solution, stirs and mixes to obtain colostrum;

[0049] (4) High-pressure homogenization: the colostrum is subjected to high-pressure homogenization, a...

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Abstract

An equipment and preparation method for preparing lipid microspheres, using a three-stage online disperser to process and cyclically shear the colostrum, and the three-stage online disperser combined with a high-speed shear emulsification head emulsification can improve the stability of the colostrum and overcome the colostrum During the process of emulsification and temporary storage, the phase separation of floating oil on the surface occurs, and the lipid microspheres prepared on the basis of controlling the preparation conditions have uniform particle size and stable content.

Description

technical field [0001] The invention relates to the field of chemical industry, in particular to a device and a preparation method for preparing lipid microspheres, and a preparation method of lipid microspheres. Background technique [0002] Lipid nanospheres (lipid nanospheres, LN) are based on vegetable oil, outsourced with phospholipid nanospheres, made of oil phase, emulsifier, and water phase, with a particle size in the range of 100-300nm, stable oil-in-water (O / W ) dispersion system. The drug can be encapsulated in the oil phase and the phospholipid interface membrane. The drug-loading system requires that the drug has strong fat solubility, or that the encapsulated drug can be converted into an active substance in a rapid and timely manner after reaching the target site to exert its curative effect. Before the site, leak release rarely occurs. The conventional preparation method is to dissolve the drug and (or) emulsifier in the water phase or the oil phase, heat ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): B01J13/04B01F3/08
CPCB01J13/04B01F23/43
Inventor 谢志梅刘长宏李荣威
Owner 本溪恒康制药有限公司