本文選題：聚碳酸亞丙酯 + 體內(nèi)分布��； 參考：《吉林大學(xué)》2013年博士論文

【摘要】：可降解生物醫(yī)用高分子材料（Degradable mediacal biomaterial，DMB）的研發(fā)是生物醫(yī)用高分子材料中最活躍與熱門的研究領(lǐng)域之一，此類材料通過與活組織接觸，可實(shí)現(xiàn)對(duì)疾病的診斷和治療，及對(duì)組織和器官的替換或增進(jìn)等功能。DMB在醫(yī)學(xué)中的應(yīng)用十分廣泛，例如藥物釋放系統(tǒng)、手術(shù)縫合線、人造皮膚、骨科固定材料、血管移植與外科粘合劑等。DMB具有可降解、穩(wěn)定性好、對(duì)環(huán)境的污染小以及成本低廉等特點(diǎn)，多年來各國(guó)科學(xué)家一直競(jìng)相開發(fā)并嘗試應(yīng)用于人體。與金屬和陶瓷相比，DMB在性能和結(jié)構(gòu)等方面與人體更接近，但是它對(duì)于生物體來說畢竟是異物，如果不具備良好的生物相容性，則會(huì)導(dǎo)致機(jī)體產(chǎn)生炎癥、過敏或凝血等不良反應(yīng)。除此之外，DMB如開發(fā)成體內(nèi)醫(yī)用制品，還應(yīng)具備合適的仿生性能，以滿足不同需求。聚碳酸亞丙酯（Poly(propylene carbonate），PPC）是由二氧化碳和環(huán)氧丙烷合成的高分子聚合物，降解產(chǎn)物為二氧化碳和水，可作為DMB原料。PPC雖具有良好的生物相容性和很低的氧透過率，但是由于其柔韌性較大，力學(xué)性能差等原因限制了多領(lǐng)域的應(yīng)用。 本研究前期工作中將聚碳酸亞丙酯（PPC）與β-羥基丁酸酯（PHB）按照80：20的比例進(jìn)行改性與共混，研制出新型改性聚碳酸亞丙酯（M-PPC2），已在一定程度上提高PPC及M-PPC1（課題組前期材料，PPC:PHB=7:3）的力學(xué)及機(jī)械性能。本研究根據(jù)中華人民共和國(guó)國(guó)家標(biāo)準(zhǔn)GB/T16886中醫(yī)療器械生物學(xué)評(píng)價(jià)標(biāo)準(zhǔn)中的相關(guān)要求，選用細(xì)胞毒性實(shí)驗(yàn)、過敏實(shí)驗(yàn)、急性全身毒性實(shí)驗(yàn)、溶血實(shí)驗(yàn)、熱原實(shí)驗(yàn)以及皮膚刺激實(shí)驗(yàn)對(duì)M-PPC2進(jìn)行生物安全性評(píng)價(jià)。并以放射性同位素125I標(biāo)記M-PPC2，以研究其在生物體內(nèi)的分布及穩(wěn)定性，并將125I標(biāo)記后的M-PPC2長(zhǎng)期植入家兔體內(nèi)，研究其降解產(chǎn)物或中間產(chǎn)物在體內(nèi)的代謝途徑。結(jié)果表明：M-PPC2具有良好的生物安全性；M-PPC2具有良好的穩(wěn)定性、材料短期大量入血后主要分布于肝臟；長(zhǎng)期肌肉植入后M-PPC2可能的降解中間產(chǎn)物分布于肝臟，材料降解后較少經(jīng)血液和尿液代謝。研究結(jié)果為M-PPC2作為DMB在醫(yī)療領(lǐng)域中更廣泛的應(yīng)用提供了基礎(chǔ)研究數(shù)據(jù)。 本研究的創(chuàng)新點(diǎn)在于： 1、首次對(duì)本課題組前期研制的M-PPC2的生物安全性進(jìn)行研究，驗(yàn)證了該材料具有良好的生物安全性，可以作為生物醫(yī)用材料。 2、首次進(jìn)行了M-PPC2的體內(nèi)分布及代謝研究，找到了M-PPC2的體內(nèi)分布、代謝途徑：M-PPC2的可能中間降解產(chǎn)物主要分布于肝臟，，材料降解后較少經(jīng)血液和尿液代謝。
[Abstract]:The research and development of biodegradable mediacal biomaterial biomaterials is one of the most active and popular research fields in biomedical polymer materials. Through contact with living tissues, these materials can be used to diagnose and treat diseases. DMB is widely used in medicine, such as drug release system, surgical suture, artificial skin, orthopedic fixation materials, vascular graft and surgical adhesives. Because of its good stability, low environmental pollution and low cost, scientists all over the world have been competing to develop and apply it to human body for many years. Compared with metals and ceramics, DMB is more similar to human body in performance and structure, but it is a foreign body for organism after all. If it does not have good biocompatibility, it will lead to inflammation, allergies or blood clotting and other adverse reactions. In addition, if DMB is developed into medical products in vivo, it should also have suitable bionic properties to meet different requirements. Poly (propylene carbonate) is a polymer synthesized from carbon dioxide and propylene oxide. The degradation product is carbon dioxide and water, which can be used as raw material of DMB, although it has good biocompatibility and low oxygen permeability. However, due to its flexibility and poor mechanical properties, many applications are limited. In this study, poly-propylene carbonate (PPC) and 尾 -hydroxybutyrate (PHBB) were modified and blended at 80:20. A new modified poly (propylene carbonate) M-PPC _ (2) has been developed, which has improved the mechanical and mechanical properties of PPC and M-PPC _ (1) to some extent. In this study, according to the relevant requirements of the biological evaluation standard of medical devices in GB/T16886, the cytotoxicity test, allergy test, acute systemic toxicity test, hemolysis test were selected. The biosafety of M-PPC2 was evaluated by pyrogen test and skin stimulation test. M-PPC2 was labeled with radioisotope 125I to study the distribution and stability of M-PPC2, and the 125I-labeled M-PPC2 was implanted into rabbits for a long time to study the metabolic pathway of its degradation product or intermediate product in vivo. The results showed that the biological safety of% M-PPC2 was good, and M-PPC2 was mainly distributed in the liver after a large amount of blood injection, and the degradation intermediate product of M-PPC2 was distributed in the liver after long-term muscle implantation. After degradation, the materials were less metabolized by blood and urine. The results provide basic research data for the wider application of M-PPC2 as DMB in medical field. The innovations of this study are: 1. For the first time, the biosafety of M-PPC2 developed by our research group was studied for the first time, and it was proved that this material has good biological safety and can be used as biomedical material. 2. The distribution and metabolism of M-PPC2 in vivo were studied for the first time, and the distribution of M-PPC2 in vivo was found. The possible intermediate degradation product of the metabolic pathway: M-PPC2 was mainly distributed in the liver, and the material was less metabolized by blood and urine after degradation.
【學(xué)位授予單位】：吉林大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2013
【分類號(hào)】：R318.08

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