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Preparation method of drug-loadable gelatin embolization microspheres

A technology of gelatin and microspheres, which is applied in medical science, application, surgery, etc. It can solve the problem of the inability of smaller and larger size microspheres, the uncertain time of in vivo degradation of blood vessel recanalization, and the difficulty of uniform particle size of microspheres. In order to achieve the effects of shortening the degradation time range, improving the embolization efficiency, and improving the success rate of embolization

Pending Publication Date: 2019-02-12
杭州艾力康医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Long-term clinical experiments have shown that gelatin embolization products currently on the market have no definite degradation time, which leads to uncertain degradation and recanalization time in vivo
Traditional gelatin microspheres degrade in a relatively long time range, such as 14 to 90 days, which is not conducive to clinical monitoring
In addition, the preparation methods of microspheres at this stage are all controlled on a large scale, and the size of the microspheres is wide, so it is difficult to achieve uniform particle size of the microspheres
Therefore, there are still problems such as uneven particle size and uncontrollable size preparation.
If the size is too large, it is difficult to effectively embolize the peripheral blood vessels; if the size is too small, it is easy to cause embolism and necrosis at the wrong site, resulting in serious complications
For example, gelatin microspheres of 100-300um, 300-500um, and 500-700um can be produced by emulsification cross-linking polymerization in existing patents, but the smaller and larger sizes of microspheres are still not available, and the size range is too wide

Method used

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  • Preparation method of drug-loadable gelatin embolization microspheres
  • Preparation method of drug-loadable gelatin embolization microspheres
  • Preparation method of drug-loadable gelatin embolization microspheres

Examples

Experimental program
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Effect test

Embodiment 1

[0040] (1) Prepare a gelatin solution, dissolve the gelatin in water for injection to prepare 900ml of a gelatin solution with a mass fraction of 20%, heat and stir in a water bath at 50°C for 1.0h until uniformly dissolved. After dissolving, sonicate for 30 minutes to remove the air bubbles in the solution, seal it and place it in a water bath at 50°C to keep warm for later use;

[0041](2) To synthesize gelatin microspheres, measure 3000ml of liquid paraffin and pour it into the reaction kettle, set the reaction temperature to 50°C, set the stirring speed to 300-500rpm, use a peristaltic pump dripping device, select the needle size as 20G, and put the step (1 ) was added dropwise to liquid paraffin at a flow rate of 10ml / min. After the dropwise addition, the temperature of the reaction system was lowered to 10-12°C, and 0.1mol / l sodium hydroxide solution was added to adjust the pH value of the system to 8.0-8.5 160ml of formaldehyde solution with a mass percentage concentrat...

Embodiment 2

[0049] (1) Prepare gelatin solution, dissolve gelatin in water for injection, prepare 900ml of gelatin solution with a mass fraction of 15%, heat and stir in a water bath at 60°C for 1.0h until it dissolves evenly, and remove it from the solution with ultrasound for 30min after dissolution bubbles, seal and place in a 60°C water bath to keep warm for later use;

[0050] (2) To synthesize gelatin microspheres, measure 5000ml of liquid paraffin and pour it into a reaction kettle, set the reaction temperature to 60°C, and set the stirring speed to 700-1000rpm. Use the microfluidic chip device to drop the gelatin solution in step (1), select the inner diameter of the chip pipe outlet as 50 μm, control the flow rate of the gelatin solution to 5ml / min, reduce the temperature of the reaction system to 5°C after the addition is completed, and add 0.1mol / 1 potassium hydroxide solution to adjust the pH value of the system to 8.5-9.0, and use a constant pressure titration funnel to add ...

Embodiment 3

[0058] (1) Prepare gelatin solution, dissolve gelatin in water for injection, prepare 900ml of gelatin solution with a mass fraction of 10%, and heat and stir in a water bath at 60°C for 1.0h until it dissolves evenly. After dissolving, use ultrasound for 30min to remove it from the solution bubbles, seal and place in a 60°C water bath to keep warm for later use;

[0059] (2) To synthesize gelatin microspheres, measure 3000ml of ethyl acetate and pour it into the reaction kettle, set the reaction temperature to 50°C, set the stirring speed to 100-300rpm, use a peristaltic pump to drop gelatin device, select the needle size as 20G, and put the step (1) The gelatin solution in (1) is added dropwise in the described ethyl acetate with the flow rate of 15ml / min, after dropping is finished, reduce reaction system temperature and be 10 ℃, add the sodium hydroxide solution of 1mol / l to adjust system pH value to 8.0 to 9.0, use a constant pressure titration funnel to add 200ml of form...

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Abstract

The invention discloses a preparation method of drug-loadable gelatin embolization microspheres. The preparation method comprises the followings steps: dissolving gelatin into injection water to prepare a gelatin water solution; then putting the gelatin water solution into a water bath at the temprature of 40 to 70 DEG C and stirring; carrying out ultrasonic treatment and heat insulation for lateruse; taking an oil-phase solution and putting into a reaction container; adding the gelatin water solution into the oil-phase solution; after dropwise adding the solution, reducing the temperature ofa reaction system; adding an alkaline substance to regulate the pH (Potential of Hydrogen) value of the system; adding a crosslinking agent water solution and controlling the time for dropwise adding; after dropwise adding the solution, continually reacting at constant temperature; after reaction is finished, carrying out post-treatment on an obtained solution to obtain the drug-loadable gelatinembolization microspheres. The gelatin microspheres, which are synthesized through the method in a single batch, have a uniform grain diameter size and a narrow grain diameter range; the reaction process is controllable, the gelatin microspheres with different specifications can be synthesized through controlling reaction conditions and the grain diameter range of the microspheres is 50 to 2500 mum. The drug-loadable gelatin embolization microspheres synthesized by the method have the advantages that the degradation time range is reduced and the embolization efficiency is improved.

Description

technical field [0001] The invention relates to a preparation method of drug-loadable gelatin embolization microspheres. Background technique [0002] As one of the most important basic techniques of interventional radiology, transcatheter vascular embolization (TAE) is guided by medical imaging equipment, injecting or introducing embolic substances into the target blood vessel through the catheter to occlude the blood vessel, so as to achieve the desired therapeutic purpose The advanced technology has the advantages of minimal invasiveness, accurate positioning, low complications, good curative effect and strong repeatability. In recent years, more and more embolic substances have been approved by the State Food and Drug Administration CFDA for clinical embolization of blood vessels and tumors, including polyvinyl alcohol particle embolism, polyvinyl alcohol embolization microspheres, medical polyether poly Ammonia lipid embolism, etc. Moreover, embolization therapy has a...

Claims

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Application Information

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IPC IPC(8): A61L24/10
CPCA61L24/0015A61L24/0042A61L24/104A61L2430/36C08L89/00
Inventor 吴健王鹏飞黄乃近程百齐
Owner 杭州艾力康医药科技有限公司
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