CN101023926A - 植入材料 - Google Patents
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Abstract
一种形状体，其特征在于，包含至少以下一种抗生素：豆蔻酸庆大霉素、棕榈酸庆大霉素、硬脂酸庆大霉素、豆蔻酸妥布霉素、棕榈酸妥布霉素、硬脂酸妥布霉素、豆蔻酸阿米卡星、棕榈酸阿米卡星、硬脂酸阿米卡星、棕榈酸万古霉素、硬脂酸万古霉素、棕榈酸雷莫拉宁、硬脂酸雷莫拉宁、棕榈酸左氧沙星、硬脂酸左氧沙星、棕榈酸氧氟沙星、硬脂酸氧氟沙星、棕榈酸莫西沙星、硬脂酸莫西沙星、棕榈酸克林霉素和硬脂酸克林霉素。
Description
技术领域
本发明主要提供一种在治疗骨髓炎过程中可作为降解材料植入的局部抗菌生物材料。
背景技术
目前，骨髓炎的治疗仍然是骨科领域中的一个难题。其病因可由血源性、外伤或手术后所引起。尤其是慢性骨髓炎可能导致截肢，甚至在个别患者中可造成致命的脓毒血症。通常情况下，慢性骨髓炎的治疗主要为彻底的病灶清除术，将受感染的病变组织以及死骨彻底清除。随后遗留的空腔由含抗生素的材料填充或进行持续引流冲洗术。局部组织所填充的载体复合抗生素通过渗透而发挥其作用，比如庆大霉素在临床中的应用。
近似球形的缓释系统由聚甲基丙烯酸甲酯、二氧化锆和常规的水溶性抗生素，如硫酸庆大霉素就由Klaus Klemm(专利DE2320373)于1975年首次报道。这项专利被证明是成功的，然而其中也存在着一些不足，球状物的抗生素只有很少一部份被释放出来。
随着载体材料的进一步发展，Heuser和Dingeldin于1978年提出通过加入甘氨酸或其它氨基酸来增加抗生素的释放(专利DE2651441)。在有血液或渗出物的创口内，氨基酸复合材料得以溶解和释放。这就增加了抗生素的释放量。根据这一理念设计出并且目前在临床中应用如Septopal链。在这些材料中，聚合物复合于钢丝上，其释放的速度取决于聚合物的构成。其中Septopal链最大的缺点在于植入10天后必须再次取出。二次取出手术为病人带来不便和额外的经济负担。
随后的研究侧重于发明一种可以完全生物降解的链状缓释系统而替代以前传统的缓释系统。
DE3037270中的材料由一可以降解的生物胶材料形成的丝状结构组成，一种抗生素被复合于该材料中。
US5756127提供一种链珠状载体，其由硫酸钙复合生物降解材料，硫酸钙作为载体植入。然而需要指出的是，偶有报道硫酸钙可能与血液肿瘤的形成有关。
DE10227935仅提供了一种多孔载体外覆抗生素的脂肪酸盐。DE10114244A1描述了一种复合物由易溶性抗生素和烃基磺酸盐以及赋形剂组成，其植入体内后而发挥抗菌作用。在这个专利中，需要指出的是仅有少量的抗生素能在植入原位于水或体液存在的情况下发生相互盐分交换。
DE10114364A1提供了一种抗生素如脂肪酸盐、有机硫酸盐或磺酸盐，而后加入含有机或无机物质的赋形剂。
综上所述，可以看出在DE2320373、DE2651441、DE3037270和US5756127这些专利中，一个基本的规律是这些基质在充足的血液或伤口分泌物存在的情况下而缓慢释放。以上缓释系统的不足之处在于这些基质制作过程相当困难，抑或其分解物在降解过程中由于人体的吸收而引起相应的副作用。
发明内容
本发明的目的在于提供一种植入物，其在治疗骨髓炎的过程中缓慢释放抗生素，能够起到一个“储存池”样的作用。同时也能克服已知庆大霉素链珠缓释系统的一些缺点。
本发明的目的是通过如下方式实现的：一种植入材料为轴性对称或不规则的形状体，其中复合至少一种水溶性抗生素，包括豆蔻酸庆大霉素、棕榈酸庆大霉素、硬脂酸庆大霉素、豆蔻酸妥布霉素、棕榈酸妥布霉素、硬脂酸妥布霉素、豆蔻酸阿米卡星、棕榈酸阿米卡星、硬脂酸阿米卡星、棕榈酸万古霉素、硬脂酸万古霉素、棕榈酸雷莫拉宁、硬脂酸雷莫拉宁、棕榈酸左氧沙星、硬脂酸左氧沙星、棕榈酸氧氟沙星、硬脂酸氧氟沙星、棕榈酸莫西沙星、硬脂酸莫西沙星、棕榈酸克林霉素和硬脂酸克林霉素。这些名词如棕榈酸、硬脂酸和豆蔻酸可以理解为这些酸盐的抗生素。在本发明中，正价的氨基酸与阴离子脂肪酸的比率为1。然而只有一部份氨基酸可以作为脂肪酸阴离子的配对。相应的，比如五棕榈酸庆大霉素、四棕榈酸庆大霉素和三棕榈酸庆大霉素可以作为水溶性抗生素。
根据本发明的一种医用植入装置，其中上述对称或不规则形状体以1～25mm的间距排列在可生物降解的纤维材料上。这种类型的医用植入装置优选有10、20或者30个形状体，围绕纤维轴形成。理论上任何可吸收的生物纤维材料都可以使用。上述抗生素可以被制成所需要的形状而不需要加入额外的赋形剂。尽管加入赋形剂是可行的，这里也不需要加入常规的无机或有机基质。而这些赋形剂如棕榈酸、豆蔻酸、硬脂酸、三棕榈甘油、三豆蔻酸甘油或三硬脂酸甘油通常情况下可以占到90％比重。
本发明同时也提供了关于前述装置的制作工艺。在该项目中，用已知的方式将这些水溶性盐压制复合到纤维上，并且加热到50～70℃。
被制成球状的棕榈酸庆大霉素颗粒(活性系数为251)每颗质量为30mg(相当于每颗含庆大霉素7.5mg)，其间距在纤维轴上的距离为10mm，目的是为了防止过量剂量，其结果证明是有效的。这样它的显著优点就在于由一种或多种可溶性抗生素盐的释放与赋形剂同步，并且每一个体之间保持着一定的距离。这就避免了过量吸收的可能性。它的链珠状排列结构保证了大量的骨空腔结构可由相当数量的颗粒来填充。该生物材料突出的优点还在于其不需要额外的基质成型剂，这也就避免了由于基质降解而带来的一系列问题。另外一个优点还在于该植入材料由过量的含抗生素的脂肪酸构成。这些过量的脂肪酸比如棕榈酸和硬脂酸是人体的自然有机构成部分，其通过β氧化来代谢，而不存在任何问题。
生物可降解纤维由编织而成，多聚糖原纤维尤其适合。
尽管加入易水溶性抗生素在材料制作过程中，但在本发明中并非如此。水溶性抗生素，比如硫酸庆大霉素、硫酸妥布霉素、硫酸阿米卡星、盐酸左氧沙星、盐酸氧氟沙星、盐酸莫西沙星和盐酸克林霉素。水溶性抗生素的优点在其于液体存在的情况下植入后初始前四个小时保持着很高的浓度。这使得加入更多的水溶性抗生素物质变得容易。
根据本项发明，链珠状植入材料不需要额外的基质。
具体实施方式
本发明可以通过以下的实施例来做进一步说明：
实施例1：
使用传统的制片机，将棕榈酸庆大霉素粉(活性系数为251)制成长方形状体，质量为35mg(相当于8.8mg庆大霉素)。两个形状体被用来测定庆大霉素的释放和贮存在20ml的磷酸盐缓冲液中(pH7.4，37℃)。每天15ml的缓释液被移取，并且再加入15ml的新磷酸缓冲液。Abbott氏TDX分析仪被用来测定庆大霉素的浓度。结果见表1。
实施例2：
使用特殊的制片机，将棕榈酸庆大霉素粉(活性系数为251)制成、每个质量为30mg(相当于7.5mg庆大霉素)的长方形状体，压于编织的多糖纤维上，间距为10～11mm。剪下两个用来测定庆大霉素的释放和贮存在20ml的磷酸盐缓冲液中(pH7.4，37℃)。每天15ml的缓释液被移取，并且再加入15ml的新磷酸缓冲液。Abbott氏TDX分析仪被用来测定庆大霉素的浓度。结果见表1。
| 时间(天) | 累计庆大霉素释放量(ug/个形状体) | |||||||
| 1 | 2 | 3 | 4 | 7 | 8 | 9 | 10 | |
| 实施例1 | 1192 | 1759 | 2375 | 3641 | 3974 | 4294 | 4550 | 4773 |
| 实施例2 | 1101 | 1696 | 2315 | 3581 | 3920 | 4255 | 4504 | 4760 |
Claims (6)
1.一种形状体，其特征在于，包含至少以下一种抗生素：豆蔻酸庆大霉素、棕榈酸庆大霉素、硬脂酸庆大霉素、豆蔻酸妥布霉素、棕榈酸妥布霉素、硬脂酸妥布霉素、豆蔻酸阿米卡星、棕榈酸阿米卡星、硬脂酸阿米卡星、棕榈酸万古霉素、硬脂酸万古霉素、棕榈酸雷莫拉宁、硬脂酸雷莫拉宁、棕榈酸左氧沙星、硬脂酸左氧沙星、棕榈酸氧氟沙星、硬脂酸氧氟沙星、棕榈酸莫西沙星、硬脂酸莫西沙星、棕榈酸克林霉素和硬脂酸克林霉素。
2.如权利要求1所述的形状体，其特征在于，该形状不固定。
3.如权利要求1所述的形状体，其特征在于，该形状为轴性对称。
4.一种医用植入装置，其特征在于，在该装置中，如权利要求1～3中任一权利要求所述的形体以1～25mm的间距排列在可生物降解的纤维材料上。
5.如权利要求4所述的装置，其特征在于，纤维材料由编织而成。
6.用于制造如权利要求4或5所述的装置的方法，其特征在于，将以下至少一种抗生素：豆蔻酸庆大霉素、棕榈酸庆大霉素、硬脂酸庆大霉素、豆蔻酸妥布霉素、棕榈酸妥布霉素、硬脂酸妥布霉素、豆蔻酸阿米卡星、棕榈酸阿米卡星、硬脂酸阿米卡星、棕榈酸万古霉素、硬脂酸万古霉素、棕榈酸雷莫拉宁、硬脂酸雷莫拉宁、棕榈酸左氧沙星、硬脂酸左氧沙星、棕榈酸氧氟沙星、硬脂酸氧氟沙星、棕榈酸莫西沙星、硬脂酸莫西沙星、棕榈酸克林霉素和硬脂酸克林霉素压于纤维材料上，而后加热到50～70℃。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102006007245.6 | 2006-02-15 | ||
| DE102006007245A DE102006007245A1 (de) | 2006-02-15 | 2006-02-15 | Implantatmaterial |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101023926A true CN101023926A (zh) | 2007-08-29 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2007100852209A Pending CN101023926A (zh) | 2006-02-15 | 2007-02-13 | 植入材料 |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US7858109B2 (zh) |
| EP (1) | EP1820496B1 (zh) |
| JP (1) | JP5226956B2 (zh) |
| CN (1) | CN101023926A (zh) |
| AT (1) | ATE527992T1 (zh) |
| AU (1) | AU2007200395B2 (zh) |
| BR (1) | BRPI0700273A (zh) |
| CA (1) | CA2570758C (zh) |
| DE (1) | DE102006007245A1 (zh) |
| DK (1) | DK1820496T3 (zh) |
| ES (1) | ES2374976T3 (zh) |
| PL (1) | PL1820496T3 (zh) |
| PT (1) | PT1820496E (zh) |
| ZA (1) | ZA200701306B (zh) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102010020940B4 (de) * | 2010-05-19 | 2014-09-25 | Heraeus Medical Gmbh | Antibiotische Beschichtung |
| ES2608695T3 (es) * | 2011-06-03 | 2017-04-12 | Waldemar Link Gmbh & Co. Kg | Procedimiento para la obtención de un revestimiento de implante e implante correspondiente |
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| DE3037270A1 (de) | 1980-10-02 | 1982-05-19 | Ulatowski, Lothar, Dr.med., 5630 Remscheid | Fibrinantibiotikumverbundketten |
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| CA2451187C (en) * | 2001-06-22 | 2012-08-14 | Southern Biosystems, Inc. | Zero-order prolonged release coaxial implants |
| US6648849B2 (en) * | 2001-06-27 | 2003-11-18 | Ethicon, Inc. | Medicinal implant and device and method for loading and delivering implants containing drugs and cells |
| DE10262176B4 (de) * | 2002-06-21 | 2007-10-04 | Heraeus Kulzer Gmbh | Verfahren zur Herstellung von antibiotisch beschichteten porösen Körpern sowie Verwendung |
| US7393687B2 (en) * | 2004-07-16 | 2008-07-01 | William Marsh Rice University | Biomimetic 3-dimensional scaffold with metabolic stream separation for bioartificial liver device |
-
2006
- 2006-02-15 DE DE102006007245A patent/DE102006007245A1/de not_active Withdrawn
- 2006-12-11 CA CA2570758A patent/CA2570758C/en not_active Expired - Fee Related
-
2007
- 2007-01-25 PL PL07001576T patent/PL1820496T3/pl unknown
- 2007-01-25 ES ES07001576T patent/ES2374976T3/es active Active
- 2007-01-25 PT PT07001576T patent/PT1820496E/pt unknown
- 2007-01-25 AT AT07001576T patent/ATE527992T1/de active
- 2007-01-25 EP EP07001576A patent/EP1820496B1/de not_active Not-in-force
- 2007-01-25 DK DK07001576.3T patent/DK1820496T3/da active
- 2007-01-31 AU AU2007200395A patent/AU2007200395B2/en not_active Ceased
- 2007-02-13 CN CNA2007100852209A patent/CN101023926A/zh active Pending
- 2007-02-14 ZA ZA200701306A patent/ZA200701306B/xx unknown
- 2007-02-14 BR BRPI0700273-4A patent/BRPI0700273A/pt not_active IP Right Cessation
- 2007-02-14 JP JP2007033569A patent/JP5226956B2/ja not_active Expired - Fee Related
- 2007-02-15 US US11/675,127 patent/US7858109B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| CA2570758A1 (en) | 2007-08-15 |
| AU2007200395B2 (en) | 2007-11-29 |
| EP1820496A3 (de) | 2008-07-09 |
| US20070190109A1 (en) | 2007-08-16 |
| DK1820496T3 (da) | 2012-01-23 |
| PL1820496T3 (pl) | 2012-03-30 |
| JP5226956B2 (ja) | 2013-07-03 |
| JP2007217413A (ja) | 2007-08-30 |
| AU2007200395A1 (en) | 2007-08-30 |
| US7858109B2 (en) | 2010-12-28 |
| ES2374976T3 (es) | 2012-02-23 |
| EP1820496B1 (de) | 2011-10-12 |
| PT1820496E (pt) | 2012-01-13 |
| EP1820496A2 (de) | 2007-08-22 |
| ATE527992T1 (de) | 2011-10-15 |
| DE102006007245A1 (de) | 2007-08-23 |
| CA2570758C (en) | 2011-07-19 |
| BRPI0700273A (pt) | 2007-11-06 |
| ZA200701306B (en) | 2008-07-30 |
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