Manufacture method for surgical implant-level poly(L-lactic acid)

A technology of surgical implantation and manufacturing method, applied in the direction of organic chemistry, organic chemistry, etc., can solve the problems of uncontrolled insoluble particles, large monomer residue, small optical rotation, etc., to improve biocompatibility and reliability. Degradability, remarkable effect, and the effect of reducing particle pollution

Active Publication Date: 2017-12-22
CHENGDU MEDART MEDICAL SCI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This manufacturing method can solve the problems of poly-L-lactic acid with large monomer residues, uncontrolled insoluble particles, low optical rotation, and excessive pyrogens.

Method used

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  • Manufacture method for surgical implant-level poly(L-lactic acid)
  • Manufacture method for surgical implant-level poly(L-lactic acid)
  • Manufacture method for surgical implant-level poly(L-lactic acid)

Examples

Experimental program
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Effect test

Embodiment 1

[0027] A kind of manufacture method of surgical implant grade poly-L-lactic acid, comprises the following steps:

[0028] Preparation of L-lactide: (1) Add 120kg of L-lactic acid into the reactor, keep it at 115°C under normal pressure for 1 hour, and remove the free water in the L-lactic acid; (2) Add Stir and mix 800g of stannous octoate evenly to disperse stannous octoate evenly in the system, raise the temperature to 150°C, and vacuumize to keep the vacuum degree ≤ -0.09MPa, dehydration and condensation for 4h; (3) After the dehydration polycondensation is completed, replace Keep the vacuum in the receiver, and quickly raise the temperature to 210°C, the product flows into the receiver and crystallizes rapidly, when the product is significantly reduced, stop the reaction; get the crude lactide; (4) After the crude lactide is cooled, add 120kg of ethyl acetate was heated to 40°C to dissolve it completely, placed in a low-temperature environment for recrystallization, and th...

Embodiment 2

[0031] A kind of manufacture method of surgical implant grade poly-L-lactic acid, comprises the following steps:

[0032] Preparation of L-lactide: (1) Add 180kg of L-lactic acid into the reactor, keep it at 105°C for 2 hours under normal pressure, and remove the free water in the L-lactic acid; (2) Add Stir and mix 1800g of stannous octoate evenly to disperse stannous octoate evenly in the system, raise the temperature to 140°C, and vacuumize to keep the vacuum degree ≤ -0.09MPa, dehydration and condensation for 6h; (3) After the dehydration polycondensation is completed, replace Keep the vacuum in the receiver, and quickly raise the temperature to 180°C, the product flows into the receiver and crystallizes quickly, when the product is significantly reduced, stop the reaction; get the crude lactide; (4) After the crude lactide is cooled, add 180kg of ethyl acetate was heated to 30°C to dissolve it completely, placed in a low temperature environment for recrystallization, and ...

Embodiment 3

[0035] A kind of manufacture method of surgical implant grade poly-L-lactic acid, comprises the following steps:

[0036]Preparation of L-lactide: (1) Add 1.2kg of L-lactic acid into the reactor, keep it at 120°C under normal pressure for 1.5h, remove the free water in the L-lactic acid; Add 6g of stannous octoate, stir and mix evenly, so that stannous octoate is uniformly dispersed in the system, heat up to 180 ° C, and vacuumize, keep the vacuum degree ≤ -0.09MPa, dehydration condensation 3h; (3) After dehydration polycondensation is completed , replace the receiver, keep the vacuum, and quickly heat up to 230 ° C, the product flows into the receiver and crystallizes quickly, when the product is significantly reduced, stop the reaction; the crude lactide is obtained; (4) after the crude lactide is cooled , add 2kg of ethyl acetate, heat to 20°C to dissolve it completely, place it in a low temperature environment for recrystallization, and then filter to obtain white flaky cr...

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Abstract

The invention relates to a manufacture method for surgical implant-level poly(L-lactic acid). The method comprises the following steps: mixing L-lactic acid and a catalyst, performing reduced-pressure distillation to obtain a crude product DL-lactide, and performing recrystallization to obtain high-purity DL-lactide; performing a reaction on the DL-lactide, a catalyst and an end-capping agent under vacuum and nitrogen introducing circulation conditions to obtain poly(L-lactic acid); and performing dissolving, performing recrystallization, and performing drying to obtain the implant-level poly(L-lactic acid) which can be supplied for surgery. According to the poly(L-lactic acid) prepared by the manufacture method, the physical and chemical properties of the poly(L-lactic acid) can fully meet a YY/T 0661-2008 (standard specification for virgin poly(L-lactic acid) resin for surgical implants), and the poly(L-lactic acid) has remarkable effects on aspects such as monomer residues, an optical rotation and microparticle control (requirements that the number of microparticles with sizes of 10 micrometers or more in 1 g is 200 at most, and the number of microparticles with sizes of 25 micrometers or more in 1 g is 100 at most are met). The high-optical-purity poly(L-lactic acid) can be better and normally metabolized by people, and biocompatibility between the poly(L-lactic acid) and people is improved; and low-insolubility microparticles are reduced, thus possibility of aseptic inflammation is reduced.

Description

technical field [0001] The invention belongs to the technical field of polymer production, and relates to a method for manufacturing surgical implant grade poly-L lactic acid. Background technique [0002] Polylactic acid polymer has good biocompatibility and biodegradability, and is widely used in drug carriers, surgical sutures, bone repair and internal fixation materials, implants in vivo, tissue engineering scaffolds, etc., and can be directly used in the market The poly-L lactic acid used for implantation is expensive and has not been industrialized. It is only synthesized in small batches in the laboratory, which leads to many uncontrollable factors, such as large monomer residues, uncontrolled number of insoluble particles, and optical rotation. The sex is relatively small (racemization occurred in the synthesis process), which is not conducive to a series of problems such as human metabolism, microbial limit, and pyrogen exceeding the standard. [0003] At present, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08G63/08C08G63/85C07D319/12
CPCC07B2200/07C07D319/12C08G63/08C08G63/823C08G2230/00
Inventor 张晓金王军张伟孙琳琳吴建
Owner CHENGDU MEDART MEDICAL SCI CO LTD
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