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Polylactic acid microsphere, injectant and preparation method of polylactic acid microsphere

A technology of polylactic acid and microspheres, which is applied in the preparation of microspheres, microcapsule preparations, pharmaceutical formulations, etc., can solve the problems of unevenness, difficulty in evaluating the time required for rehydration, and difficulty in taking into account the performance of injections, etc., to achieve rehydration time Shortening, good anti-agglomeration and needle penetration, and improved applicability

Pending Publication Date: 2021-07-27
PANION & BF BIOTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

When the microspheres have a wide particle size distribution and non-uniform size, the time required for rehydration is difficult to estimate, and there is a high risk of unevenness after rehydration
In addition, in the current process of preparing biomacromolecules as injections, if it is desired to meet the demand for high microsphere yields, it is often difficult to take into account the performance of injections (such as needle penetration)

Method used

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  • Polylactic acid microsphere, injectant and preparation method of polylactic acid microsphere
  • Polylactic acid microsphere, injectant and preparation method of polylactic acid microsphere
  • Polylactic acid microsphere, injectant and preparation method of polylactic acid microsphere

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Embodiment 1, the preparation method of polylactic acid microsphere

[0065] The specific preparation conditions of polylactic acid microspheres are shown in Table 1 below.

[0066]First, the preparation of the dispersed phase (first solution) and the continuous phase (second solution) is carried out. The dispersed phase is obtained by adding polylactic acid (PLA) into dichloromethane (DCM), and the continuous phase is obtained by adding polyvinyl alcohol (PVA) and sodium carboxymethyl cellulose (SCMC) into water and mixing.

[0067] Next, the dispersed phase was pumped with a peristaltic pump (Thermo Fisher Scientific Dry-Bags TM SimplePeristaltic Pump Starter Pack, USA) was added to the continuous phase, mixed with a mixer (IKA EURO-ST 60 CS001, Germany) to form a mixed solution, and the rotational speed unit was revolution / minute (rpm). Although four different stirring conditions were used in this example, they were divided into groups A-D (Table 1 below) for the ...

Embodiment 2

[0072] Embodiment two, the preparation method of injection

[0073] Next, the polylactic acid microspheres obtained under four different preparation conditions (A-D) in Example 1 were prepared as injections according to formula a in Table 2 below. In addition, in order to test the difference of different injection formulations at the same time, the polylactic acid microspheres of group C in Table 1 were selected, and then formulation b and formulation c in Table 2 below were prepared as injections. The specific preparation process is as follows.

[0074] First, add 300 ml of an aqueous solution containing polysorbate 80 (TWEEN 80), polydimethylsiloxane (dimethicone), D-mannitol (D-mannitol), and sodium carboxymethylcellulose (SCMC) to freezing Mix the dry polylactic acid microspheres evenly to form a microsphere suspension. Next, the microsphere suspension is subjected to freeze-drying to obtain an injection. Freeze-drying can remove moisture, and rehydrate when ready to us...

Embodiment 3

[0077] Embodiment three, the characteristic of polylactic acid microsphere and injection

[0078] In order to further understand the characteristics of the polylactic acid microspheres and injections obtained by the preparation methods of Example 1 and Example 2, first, use an electron microscope to observe the polylactic acid microspheres under a field of view of 450 to 1500 times at an electron microscope voltage of 5kV. Appearance of lactic acid microspheres. please see Figure 2A to Figure 2D , which are respectively 470 times, 900 times, 950 times and 1300 times the field of view, and the surface of the polylactic acid microspheres can be seen to be smooth under the field of view. also, Figure 2C as well as Figure 2D It is shown that when the polylactic acid microspheres are cut open, the internal structure is a solid and smooth section.

[0079] Next, calculate the yield and particle size of the polylactic acid microspheres prepared in the A-D groups of Example 1, ...

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Abstract

The present disclosure provides a method of preparing polylactic acid microspheres, comprising the following steps: providing a first solution, wherein the first solution comprises polylactic acid and an organic solvent; providing a second solution, wherein the second solution comprises polyvinyl alcohol, sodium carboxymethyl cellulose and an aqueous solution; adding the first solution into the second solution, and stirring the second solution at the same time until the polylactic acid is cured to form a plurality of polylactic acid microspheres; and collecting the poly lactic acid microspheres. The present disclosure also provides polylactic acid microspheres. The polylactic acid microspheres are formed by aggregating polylactic acid. The surface of the polylactic acid microsphere is smooth, and the particle size is between 30 microns and 100 microns. Polylactic acid microspheres with concentrated particle size distribution and smooth surfaces can be prepared from polyvinyl alcohol and sodium carboxymethyl cellulose in a specific ratio, and the yield reaches 90%; in addition, the rehydration time of the prepared injectant is shortened, and the injectant has better coagulation resistance and needle passing performance.

Description

technical field [0001] The present disclosure relates to polylactic acid microspheres and methods for their preparation, and in particular to methods for preparing polylactic acid microspheres with high yield and better injection properties. Background technique [0002] At present, the main methods for preparing microspheres from biological macromolecules are: emulsification solvent evaporation method, emulsification solidification method, or desolvation method. [0003] The emulsified solvent evaporation method is to mix the aqueous solution containing biomacromolecules with an organic solvent, prepare an emulsion through ultrasonic or vibration method, and then remove the organic solvent by rotary evaporation to obtain microspheres. The microsphere yield of the emulsification solvent evaporation method is low and there is a risk of organic solvent residue, and the coating rate for water-soluble drugs and water-soluble substances is poor. [0004] Nowadays, the emulsifica...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K47/34A61K47/32A61K47/38B01J13/02
CPCA61K9/0019A61K9/1647A61K9/1635A61K9/1652B01J13/02
Inventor 许明照徐育盈
Owner PANION & BF BIOTECH INC
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