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Membrane emulsification assembly for producing micron-sized micro-spheres and application of membrane emulsification assembly for producing micron-sized micro-spheres

A technology of microparticle and membrane emulsification, which is applied in the preparation of microspheres, microcapsule preparations, chemical instruments and methods, etc. It can solve the problem of uneven particle size of emulsions and microspheres, difficulty in preparing 100-micron emulsion droplets, and uneven shear force. and other problems, to achieve the effect of uniform particle size, meeting sterility requirements, and simple equipment

Inactive Publication Date: 2019-11-05
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Traditional microsphere preparation methods, such as mechanical stirring method, homogeneous emulsification method, etc., all have a common problem: due to the uneven shear force, the prepared emulsion and microsphere particle size are not uniform, the repeatability is poor, and cumbersome procedures are required. Only after later screening can the products that meet the requirements be obtained
However, the particle size of emulsion droplets prepared by this method is in the range of 7 μm to 30 μm, and the pore diameter of the applied membrane tube is small, so it is difficult to prepare 100-micron emulsion droplets

Method used

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  • Membrane emulsification assembly for producing micron-sized micro-spheres and application of membrane emulsification assembly for producing micron-sized micro-spheres
  • Membrane emulsification assembly for producing micron-sized micro-spheres and application of membrane emulsification assembly for producing micron-sized micro-spheres
  • Membrane emulsification assembly for producing micron-sized micro-spheres and application of membrane emulsification assembly for producing micron-sized micro-spheres

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Experimental program
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preparation example Construction

[0032] The membrane emulsification component for preparing micron-sized microspheres can be used to prepare drug-loaded or non-drug-loaded micron-sized microspheres, and the preparation method is as follows:

[0033] see figure 2 :

[0034] (1) The polymer material is dissolved in an organic solvent as a dispersed phase;

[0035] The polymer material is selected from polylactide glycolide (PLGA), polycaprolactone (PCL), polylactic acid (PLA) or polyamide.

[0036] The organic solvent is an organic solvent capable of dissolving the polymer material, such as dichloromethane, chloroform, tetrahydrofuran, ethyl acetate or benzyl alcohol.

[0037] In the dispersed phase, the content of polymer material is 10-20g / 100mL;

[0038] Preferably, the dispersed phase also contains active drugs such as risperidone at a content of 5-15g / 100mL;

[0039] (2) dissolving water-soluble substances such as PVA in water to obtain a continuous phase, wherein the content of the water-soluble subs...

Embodiment 1

[0046] use figure 1 and figure 2 device for the preparation of risperidone microspheres.

[0047] The pitch of the membrane holes 101 is 1.5 mm, and the average pore diameter is 20 μm;

[0048] The distance between the embedded tube 2 and the membrane tube 1 is 1 mm;

[0049] Dissolve 15g of PLGA in 60mL of dichloromethane, add 7.5g of risperidone powder, dissolve and set the volume to 100mL, cool down to 10°C, as the dispersed phase.

[0050] Dissolve 240g of PVA in 12L of water and lower the temperature to 10°C as the continuous phase.

[0051] Add the dispersed phase to the dispersed phase tank 8, pressurize the dispersed phase to 12kPa through a nitrogen bottle, use a pump to circulate the continuous phase at an average flow rate of 0.38m / s in the membrane tube, and squeeze the dispersed phase through the membrane holes at a pressure of 12kPa , into the middle tank 9 of the continuous phase;

[0052] After collecting emulsion droplets and standing for 15 minutes, rep...

Embodiment 2

[0055] use figure 1 and figure 2 device to prepare non-drug-loaded PLGA microspheres.

[0056] The pitch of the membrane holes 101 is 1.5 mm, and the average pore diameter is 20 μm;

[0057] The distance between the embedded tube 2 and the membrane tube 1 is 1 mm;

[0058] Dissolve 18g of PLGA in 70mL of dichloromethane, dilute to 100mL after dissolving, and lower the temperature to 10°C as the dispersed phase.

[0059] Dissolve 300g of PVA in 15L of water and lower the temperature to 10°C as the continuous phase.

[0060] Add the dispersed phase to the dispersed phase tank 8, pressurize the dispersed phase to 25kPa through a nitrogen bottle, use a pump to circulate the continuous phase at an average flow rate of 0.20m / s in the membrane tube, and squeeze the dispersed phase through the membrane holes at a pressure of 25 , into the middle tank 9 of the continuous phase;

[0061] After collecting emulsion droplets and standing for 15 minutes, replace the continuous phase w...

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Abstract

The invention discloses a membrane emulsification assembly for producing micron-sized micro-spheres and application of the membrane emulsification assembly for producing the micron-sized micro-spheres. The membrane emulsification assembly comprises a membrane pipe jacket with two ends closed, a membrane pipe with two ends closed and an embedded pipe with two ends closed, wherein membrane holes areformed in the membrane pipe, the embedded pipe is fixed to the interior of the membrane pipe, a gap between the embedded pipe and the membrane pipe is circular, the membrane pipe is sleeved with themembrane pipe jacket through fixing parts, a continuous phase inlet is formed in one end of a gap between the membrane pipe and the embedded pipe, an emulsion outlet is formed in the other end of thegap between the membrane pipe and the embedded pipe, a dispersion phase inlet is formed between the two ends of the membrane pipe jacket, and the membrane emulsification assembly can be used for producing the micron-sized micro-spheres carried with medicines or the micron-sized micro-spheres carried with no medicines. By means of the membrane emulsification assembly for producing the micron-sizedmicro-spheres and application of the membrane emulsification assembly for producing the micron-sized micro-spheres, the technical problem of wide particle size distribution of micro-spheres with largeparticle size is solved, the produced micro-spheres have good repeatability, moreover, the particle size is uniform, particle size distribution can stabilize at 1.0 or below, micro-spheres with uniform particle size of 60-200 [mu]m can be produced, the technology is simple and convenient, and the cost is low.

Description

technical field [0001] The invention relates to a device for preparing microspheres with micron particle size and its application. Background technique [0002] The drug release period of drug-loaded microspheres with different particle sizes can vary from 10 to 80 days, and the disposal process in the body is also different. Therefore, controlling the particle size and particle size distribution of microspheres is of great significance for controlling the kinetic behavior of drugs in vivo. [0003] Traditional microsphere preparation methods, such as mechanical stirring method, homogeneous emulsification method, etc., all have a common problem: due to the uneven shear force, the prepared emulsion and microsphere particle size are not uniform, the repeatability is poor, and cumbersome procedures are required. In the later stage of sieving, the products that meet the requirements can be obtained. The concept of membrane emulsification was first proposed by Japanese scholar ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B01F3/08B01F13/00B01J13/02
CPCB01J13/02B01F23/4143B01F23/49B01F33/00
Inventor 栾瀚森祝君喆王浩赵虹杨莉
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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