Preparation method and application of medical ultra-high molecular weight poly (p-dioxanone)

Abstract

The invention discloses a preparation method of medical ultra-high molecular weight poly (p-dioxanone). The preparation method comprises the following steps: 1) purifying p-dioxanone; 2) polymerization reaction: heating a reaction kettle, filling inert gas into the reaction kettle, adding the purified p-dioxanone prepared in the step 1), and adding a catalyst and an alcohol initiator for reaction; (3) after the reaction is finished, taking out the materials and crushing the materials; and 4) heating the crushed material under a vacuum condition to remove unreacted p-dioxanone, and finally preparing the poly (p-dioxanone). The high-molecular-weight poly (p-dioxanone) prepared by the preparation method can meet medical requirements, the molecular weight can reach 300000 to 2000000, and the production magnitude can reach dozens of kilograms by using a catalyst stannous octoate accepted by FDA (Food and Drug Administration).

Description

technical field [0001] The invention relates to the technical field of medical material manufacture, more specifically, it relates to a preparation method and application of medical ultrahigh molecular weight polydioxanone. Background technique [0002] Polydioxanone (PPDO) has a very high strength and very good flexibility due to its unique ether bond in its molecular chain. It is completely biodegradable, biocompatible, and bioabsorbable. , degraded into glyoxylic acid in the body, which can be excreted through urine, and can be further degraded into glycine, which is non-toxic to the human body. PPDO has a broad application market in the medical field. [0003] The preparation of medical devices from PPDO needs to have a higher molecular weight to obtain better mechanical strength, and the molecular weight of PPDO obtained by the current preparation method is relatively low. PPDO is mainly prepared by ring-opening polymerization of dioxanone. The current research mainly...

AI Technical Summary

Problems solved by technology

[0004] Extending method: CN101096415A uses the chain extending method to increase the molecular weight of the polymer. The chain extending method has obvious effects on polymers with a molecular weight of less than 100,000, but has no significant effect on high molecular weight polymers, and the chain extension molecules are introduced into the molecular chain to achieve regularity. If it is destroyed, the crystallinity of the medical device products prepared in the later stage is low, and the mechanical properties cannot meet the requirements.

[0005] New catalyst: The molecular weight of the polymer prepared by CN110643024A has been significantly improved compared with that prepared by other catalysts, but it is still below 300,000, and the proportion of catalyst used is high, and the metal content in the polymer exceeds the standard and cannot meet the medical requirements

CN1597729A, prepared high molecular weight PPDO by screening catalysts, but the preparation level is several grams and cannot be industrialized, and the catalysts they use are not easy to obtain and use metal elements harmful to human body, which cannot meet medical requirements

[0006] Improve the purity of the monomer: improve the purity of the monomer by rectification, because the impurity properties are too similar to the monomer, it is difficult to obtain high-purity monomer US5717059 by rectification; the other is to use solvent recrystallization, this method The yield is low, resulting in a large degree of monomer waste, and the solvent residue is difficult to remove, which may have a negative impact on the application of medical devices