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 hy

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
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Example Embodiment

[0053] Example 1

[0054] The filler formulation is (wt%, the same in the following examples): L-polylactic acid 41%, honeycomb HA 11%, mannitol 48%. The molecular weight of L-polylactic acid is 50,000 Da.

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

[0056] 1. Preparation of L-polylactic acid particles: Under the conditions of working pressure of 0.6 MPa and L-polylactic acid feed rate of 60g / min, pulverize with a jet mill to prepare L-polylactic acid with an average particle size of 30μm and a molecular weight of 50,000 Da. Lactic acid microparticles, the resulting microparticles are immersed and washed twice with a pH 6.0 hydrochloric acid solution, and dried in vacuum to obtain L-polylactic acid microparticles.

[0057] 2. Preparation of honeycomb HA: Dissolve 3g of high molecular weight sodium hyaluronate with a molecular weight of 2000kDa and 7g of low molecular weight sodium hyaluronate with a molecular weight of 300kDa in 400 g of water, stir at 200 r / min for...

Example Embodiment

[0059] Example 2

[0060] Filler formula: the same as in Example 1.

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

[0062] 1. Preparation of L-polylactic acid particles: Under the conditions of working pressure of 0.6 MPa and L-polylactic acid feed rate of 60g / min, pulverize with a jet mill to prepare L-polylactic acid with an average particle size of 30μm and a molecular weight of 50,000 Da. Lactic acid microparticles, the resulting microparticles are immersed and washed twice with a pH 6.0 hydrochloric acid solution, then the L-polylactic acid microparticles are transferred to a 10 μm microporous filter and immersed in a volume fraction of 15%-20% adjusted to pH 6.0 with hydrochloric acid In the (v / v) ethanol solution, some fine particles are sieved through dead-end filtration under stirring, and dried in vacuum to obtain L-polylactic acid particles.

[0063] Figure 1-3 It is the particle size distribution tested by Winner2308A laser particle size analyzer. It can ...

Example Embodiment

[0067] Example 3

[0068] Filler formula (wt%): L-polylactic acid 41%, honeycomb HA 11%, mannitol 48%. The molecular weight of L-polylactic acid is 50,000 Da.

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

[0070] 1. Preparation of L-polylactic acid microspheres: Dissolve L-polylactic acid in dichloromethane to prepare a solution with a mass concentration of 3.0%. Take 40ml of this solution and slowly inject 640mL 0.15% (w) under stirring at 600 r / min. / v) in polyvinyl alcohol (PVA) aqueous solution, stir and emulsify at room temperature for 5 min; after the emulsification is completed, stir and volatilize under normal pressure or reduced pressure to remove dichloromethane, filter the remaining reaction solution, and wash the filter cake 3 times to obtain L-polylactic acid microspheres with a particle size of 30μm and a molecular weight of 50,000Da.

[0071] 2. Preparation of honeycomb HA: Dissolve 3g of high molecular weight sodium hyaluronate with a molecular weight...

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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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