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L-polylactide filler for injection and preparation method thereof

A technology of L-polylactic acid and fillers, which is applied in the fields of pharmaceutical formula, medical science, prosthesis, etc., can solve the problems of inconvenient application, accumulation of D-lactic acid, biocompatibility without hyaluronic acid, etc., and reduce hydration The effect of mixing time, improving skin quality, and reducing subcutaneous nodules

Active Publication Date: 2016-08-24
BLOOMAGE BIOTECHNOLOGY CORP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Sculptra and Sculptra Aesthetic use CMC-Na as the suspending agent of L-lactic acid particles. CMC-Na has two problems: one is that CMC-Na is not an endogenous substance in the human body, and its biocompatibility is not as good as that of hyaluronic acid; When CMC-Na is used as a suspending agent, Sculptra and Sculptra Aesthetic need a long time (generally about 2 hours) of hydration before they can be used for intradermal injection. As a cosmetic injection filler, it brings inconvenience to the application of patients
However, the D-lactic acid generated by the degradation of D-polylactic acid nanoparticles in the patented product in the human body cannot be directly absorbed by the human body, and it is easy to cause local D-lactic acid accumulation

Method used

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  • L-polylactide filler for injection and preparation method thereof
  • L-polylactide filler for injection and preparation method thereof
  • L-polylactide filler for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] The filler formula is (wt%, the same as in the following examples): L-polylactic acid 41%, honeycomb HA 11%, mannitol 48%. The molecular weight of poly-L-lactic acid is 50000 Da.

[0055] The preparation method of filler is as follows:

[0056] 1. Preparation of L-polylactic acid microparticles: Under the condition that the working pressure is 0.6 MPa and the feed rate of L-polylactic acid is 60g / min, it is pulverized with a jet mill to prepare L-polylactic acid particles with an average particle size of 30 μm and a molecular weight of 50000 Da. Lactic acid microparticles, the obtained microparticles were soaked and washed twice with a hydrochloric acid solution of pH 6.0, and dried in vacuum to obtain L-polylactic acid microparticles.

[0057] 2. Preparation of Honeycomb HA: Dissolve 3 g of high molecular weight sodium hyaluronate with a molecular weight of 2000 kDa and 7 g of low molecular weight sodium hyaluronate with a molecular weight of 300 kDa in 400 g of water...

Embodiment 2

[0060] Filler formula: with embodiment 1.

[0061] The preparation method of filler is as follows:

[0062] 1. Preparation of L-polylactic acid microparticles: Under the condition that the working pressure is 0.6 MPa and the feed rate of L-polylactic acid is 60g / min, it is pulverized with a jet mill to prepare L-polylactic acid particles with an average particle size of 30 μm and a molecular weight of 50000 Da. Lactic acid microparticles, the obtained microparticles were infiltrated and washed twice with a hydrochloric acid solution of pH 6.0, and then the L-polylactic acid microparticles were transferred to a 10 μm microporous filter and soaked in a volume fraction of 15%-20% with hydrochloric acid adjusted to a pH of 6.0. (v / v) ethanol solution, sieve out some tiny particles by dead-end filtration under stirring, and dry in vacuum to obtain L-polylactic acid particles.

[0063] Figure 1-3 It is the particle size distribution of the particles tested by the Winner2308A lase...

Embodiment 3

[0068] Filler formula (wt%): L-polylactic acid 41%, honeycomb HA 11%, mannitol 48%. The molecular weight of poly-L-lactic acid is 50000 Da.

[0069] The preparation method of filler is as follows:

[0070] 1. Preparation of L-polylactic acid microspheres: Dissolve L-lactic acid in dichloromethane to make a solution with a mass concentration of 3.0%, take 40ml of the solution, and slowly inject 640mL of 0.15% (w / v) in a polyvinyl alcohol (PVA) aqueous solution, stirring and emulsifying at room temperature for 5 min; after the emulsification is completed, stirring and volatilizing under normal pressure or reduced pressure to remove methylene chloride, filtering the remaining reaction solution, and washing the filter cake 3 times to obtain L-polylactic acid microspheres, particle size 30μm, molecular weight of L-lactic acid 50000Da.

[0071]2. Preparation of Honeycomb HA: Dissolve 3 g of high molecular weight sodium hyaluronate with a molecular weight of 2000 kDa and 7 g of lo...

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Abstract

The invention discloses an L-polylactide filler for injection and a preparation method thereof. Active ingredients of the filler are L-polylactide particles, honeycomb HA and a synergist, the honeycomb HA is obtained by alcohol precipitation and drying of a water solution formed by mixing sodium hyaluronate high in molecular weight and sodium hyaluronate low in molecular weight in an alkaline condition, and the synergist is mannitol or a mixture of mannitol and aloe polysaccharide with a mass ratio of 1:0.05-0.12. The filler is simple to prepare, shorter in re-suspension time, long in validity period and more convenient to use.

Description

technical field [0001] The invention relates to a poly-L-lactic acid filler for injection and a preparation method thereof, belonging to the technical field of polymer medical supplies. Background technique [0002] Polylactic acid (Polylactic acid, PLA) is a new generation of fully degradable polymer materials developed rapidly in the 1990s. It is made of lactic acid, a product of microbial fermentation, and polymerized by chemical synthesis. It is a thermoplastic aliphatic A type of resin. The raw material for the synthesis of polylactic acid contains a chiral carbon atom in its molecule, which is optically active. Therefore, polylactic acid has several different optical isotropes such as L-polylactic acid (PLLA), D-polylactic acid (PDLA), racemic polylactic acid (D, L-PLA) and mesopolylactic acid (meso-PLA). Structural aggregates. [0003] PLLA should be widely used in the field of cosmetic injections, and it has its unique features as a material for cosmetic injection...

Claims

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Application Information

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IPC IPC(8): A61L27/58A61L27/50A61L27/18A61L27/20
CPCA61L27/18A61L27/20A61L27/50A61L27/505A61L27/58A61L2400/06C08L67/04C08L5/08C08L5/00
Inventor 刘建建耿凤杨莹莹苏江伟张燕郭学平
Owner BLOOMAGE BIOTECHNOLOGY CORP LTD
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