CN110151784A - 一种用于伤口护理的载碘生物活性玻璃及其应用 - Google Patents
一种用于伤口护理的载碘生物活性玻璃及其应用 Download PDFInfo
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- CN110151784A CN110151784A CN201910318596.2A CN201910318596A CN110151784A CN 110151784 A CN110151784 A CN 110151784A CN 201910318596 A CN201910318596 A CN 201910318596A CN 110151784 A CN110151784 A CN 110151784A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
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Abstract
本发明公开了一种用于伤口护理的载碘生物活性玻璃及其应用。利用壳聚糖在碱性介质内不溶，当遇到碱性介质，形成凝聚/沉淀，得到壳聚糖微球模板，将含有各类无机元素(硅、钙、钠、磷等)的化合物，通过溶胶‑凝胶‑模板法制备中空生物活性玻璃。采用密封控温升华吸附技术制备载碘生物活性玻璃，这种组合物兼具生物活性玻璃微粒和碘分子，能有效促进人体硬、软组织损伤愈合又能发挥持久的抑制/杀灭细菌的作用，功效强，毒副作用低，鲜有免疫炎症应答反应，且便于储存、携带和使用。
Description
技术领域
本发明属于医疗卫生技术领域，具体涉及一种用于伤口护理的材料及其应用。
背景技术
日常生活中由于各种原因如创伤、交通事故、运动损伤、手术及先天性畸形等很容易造成各类组织的缺损。组织创面处自我修复过慢导致伤口不能及时愈合，外界的各种病原微生物和化学类污染物等都会通过伤口进入，导致体液流失和伤口感染，更甚者危及伤者生命。病灶区过多的细菌菌落会产生高浓度的细菌废弃物，产生慢性炎症以及较多的渗出液，增加组织坏死并扩大感染区域。当每克组织上负担的细菌数目大于105左右时，其伤口(溃疡面)一般不会愈合。根据世卫组织统计，每年死于外伤人数约500万左右，而其中就有约20％是由于皮肤过大面积的缺损而导致的伤口感染而死亡。
生物活性玻璃是一类能对机体组织进行修复、替代与再生，具有能使组织和材料之间形成键合作用的无机材料。在体内，生物活性玻璃与组织间产生离子交换，使局部外境的pH值升高，使在酸性条件下繁殖生存的细菌被抑制或杀灭，显示出抗菌活性；并在其表面形成具有巨大比表面积的支架状带负电势的碳酸羟基磷灰石层，吸附周围细胞、纤维蛋白以及胶原蛋白，利于营养和氧气进入、代谢产物排出；主动诱导细胞释放促进组织修复的信号，有利于胶原以及相关生长因子的合成；主动诱导细胞增殖、分化和爬移，利于细胞黏附生长、以及血管和神经长入，促进伤口快速愈合。
但生物活性玻璃抗菌机制与pH值有关，当生物活性玻璃的碱性被中和，则对细菌无抑制作用。为了提高抗菌性能，CN 103301151A采用有机溶剂超声分散，离心、沉淀、干燥、粉碎，获得一种掺碘化银的生物活性玻璃，这种组合物含有生物活性玻璃微粒和碘化银结晶，能够促进人体硬、软组织损伤愈合又能抑制/杀灭细菌，但所含银对人体毒性较大，应用受限。碘是一种广谱、高效的抑菌剂，具有强大的渗透作用，直接卤化蛋白，导致微生物死亡，它可以杀灭包括细菌、病毒、真菌、原生动物以及细菌芽孢等在内的几于所有的病原微生物，并且碘对多种微生物的杀灭作用浓度差别不大。但碘不溶于水，并且必须以分子状态才具有消毒作用。现在市场上的碘制剂主要分两大类，一类是通过大量的碘化钾助溶(与碘的摩尔比大于1)，碘离子作为辅料，价格昂贵却未起到消毒效果；另一类是与有机物(如聚维酮、季铵盐)形成络合物或与环糊精形成包合物来保持碘的分子状态存在，从而增加碘在水溶液中的溶解度，但该类制品有效碘含量损失快、非功效成分多、消毒成本高，制约了大规模推广应用。迄今为止，尚无将在生物活性玻璃中加入碘，使其既增加生物活性又能够不受酸碱环境的影响而保持良好抗菌性能的报道。
发明内容
本发明的目的是克服已有技术的缺陷，为了解决生物活性玻璃抗菌性能持久性问题，提出了一种用于伤口护理的载碘生物活性玻璃及其应用。
本发明是通过下述技术方案实现的：
首先将含有各类无机元素(硅、钙、钠、磷等)的化合物，通过壳聚糖微球为模板，采用溶胶-凝胶-模板法制备中空生物活性玻璃，经密封控温升华吸附技术制备载碘生物活性玻璃，这种组合物兼具生物活性玻璃微粒和碘分子，能有效促进人体硬、软组织损伤愈合又能发挥持久的抑制/杀灭细菌的作用，功效强，毒副作用低，鲜有免疫炎症应答反应，且便于储存、携带和使用。
本发明用于伤口护理的载碘生物活性玻璃的具体制备方法如下：
步骤一，以壳聚糖微球为模板，采用溶胶-凝胶-模板法制备中空生物活性玻璃；
步骤二，将中空生物活性玻璃放入真空干燥烘箱内，100℃真空干燥1h；
步骤三，采用密闭粉碎装置将碘制成180um以下的细粉；
步骤四，称取中空生物活性玻璃与碘，涡旋混合5～10min制成碘/生物活性玻璃混合物；
步骤五，将碘/生物活性玻璃混合物注入玻璃安瓿，充入N2气，熔封；
步骤六，将装药安瓿置于控温加热器中，设定温度50～70℃加热60～90min。
步骤七，将样品从安瓿取出，过200目筛，得载碘的生物活性玻璃BAG-I。
本发明所述的载碘生物活性玻璃，由下述原料按质量比组成，碘：中空生物活性玻璃＝0.1～1.5：1，优选碘：中空生物活性玻璃＝0.5～1：1。
利用壳聚糖在碱性介质内不溶，当遇到碱性介质，形成凝聚/沉淀，得到壳聚糖微球模板，以溶胶-凝胶-模板法制备中空生物活性玻璃，其实施过程如下：
步骤一，把壳聚糖加入到体积百分数为0.1～5％的酸性水溶液中，配制质量百分比浓度为1～3％的壳聚糖水溶液，补加壳聚糖水溶液1～3倍量的乙醇。
步骤二，剧烈搅拌下，将正硅酸乙酯和硝酸盐加至上述乙醇水溶液中，调 pH值至1～2，充分搅拌一段时间后，得到透明、均一的溶胶液A。
步骤三，将磷酸氢二氨、非离子亲水聚合物溶于水中，充分搅拌一段时间后，得到澄清透明的溶液B。
步骤四，将溶胶液A缓慢滴加至溶液B中，待其搅拌均匀后，向其中缓慢滴加碱性介质，溶液出现白色沉淀，继续滴加碱性介质，将pH值调为10-11。
步骤五，离心，冷冻干燥，马弗炉600～800℃高温热处理3h，除去壳聚糖微球模板，得到中空生物活性玻璃粉末。
自此，就实现了将碘包覆在生物活性玻璃中稳定地发挥抗菌效能，使其兼具抗菌和促愈作用。
本发明有益效果在于：
1、本发明提供的载碘生物活性玻璃组合物弥补了一般生物活性玻璃因pH 改变而致其抗菌性能不稳定的缺陷，克服了碘因挥发而致使用受限的不足，该组合物既具备促进人体硬、软组织迅速修复和再生的功能又具有广谱的抗菌性，能迅速杀灭细菌、病毒、酵母、霉菌等微生物，并且抑菌效能较持久，并且在临床使用中不会产生抗生素或免疫抑制剂等的毒副作用。
2、本发明的载碘生物活性玻璃是一种无机的玻璃材料，其以硅的氧化物为主要成分，另包含钙、钠、钾、磷、硼、碘等各类无机元素，不局限于上述已提及的无机元素，还包括任何对伤口愈合有利的无机元素。当这种生物活性玻璃与生理溶液发生反应时，能与生命组织相结合，并能发挥抑菌/杀菌作用。
3、本发明的载碘生物活性玻璃颗粒粒径小于50μm，绝大多数在2～20μm。如此小尺寸的颗粒能保证这种生物活性玻璃在与人体组织接触中不会产生不利的免疫应答，同时当组合物中较大颗粒粘附于骨(牙)结构或软组织上，成为提供钙、磷的离子库，使较小颗粒在人体硬、软组织不规则伤口表面的矿化作用能持续进行，并有效地充填和涂层于这些不规则的创面。较小尺寸的载碘生物活性玻璃可到达伤口或龋洞深部，有效杀灭更隐蔽的细菌菌落。
4、本发明的载碘生物活性玻璃可以以无水物的形式，也可以以水提物的形式直接涂抹、喷雾或者掺入粉剂、糊剂、凝胶剂、油膏剂、栓剂、泡腾剂、绷带之中涂敷在皮肤、黏膜、骨骼等软硬组织损伤处，预防或治疗伤口感染，促进组织修复。
5、本发明采用密封控温升华吸附技术制备载碘生物活性玻璃，制备过程中不需加入有机溶剂，无有机溶媒残留，后处理方便，对环境无污染；通过控制温度使碘升华与生物活性玻璃吸附，升华温度可控，吸附速度快，吸附率高；制备工艺简便。
6、本发明所采用的密封控温升华吸附技术尤其适用于具有空穴结构的载体和具有升华性质的物质。
附图说明
图1不同矿化时间的生物活性玻璃XRD图谱。
具体实施方式
下面结合实施例对本发明做进一步的说明。
实施例1
将0.6g壳聚糖加入到20ml 2％冰醋酸水溶液中，配制3％的壳聚糖水溶液，补加40ml乙醇。将12.5g正硅酸乙酯和8.5g四水硝酸钙加至上述乙醇水溶液中，调pH值至1～2，搅拌30min，得到透明、均一的溶胶液A。将1.056g磷酸氢二氨、2.5g PEG溶于50ml去离子水中，得到澄清透明的溶液B。将溶胶液A缓慢滴加至溶液B中，搅拌30min，匀速搅拌下向其中缓慢滴加28％氨水，待其出现乳白色沉淀，调节pH至10-11。离心，冷冻干燥，马弗炉600～800℃高温热处理 3h，得到中空生物活性玻璃粉末。
实施例2
将0.5g壳聚糖加入到20ml 2％硼酸水溶液中，配制2.5％的壳聚糖水溶液，补加40ml乙醇。将10.42g的正硅酸乙酯和10.86g四水硝酸钙加至上述乙醇水溶液中，调pH值至1～2，搅拌30min，得到透明、均一的溶胶液A。将1.056g 的磷酸氢二氨溶于20ml去离子水中，加入1g的PVA，并搅拌待其完全溶解，得到澄清透明的溶液B。将溶胶液A缓慢滴加至溶液B中，搅拌30min，匀速搅拌下逐滴滴入1.5mol/L的NaOH溶液，待pH至10-11，反应完全后，离心得到白色沉淀物，经冷冻干燥、马弗炉600℃高温热处理3h，得到中空生物活性玻璃粉末。
实施例3
将中空生物活性玻璃放入真空干燥烘箱内，100℃真空干燥1h；碘颗粒密闭研磨成细粉；按质量比0.5：1称取碘与生物活性玻璃，涡旋混合5～10min制成混合物；称取混合物1g注入5ml玻璃安瓿，充入N2气，熔封；将载药安瓶置于控温加热器中，设定温度60℃加热90min；将样品从安瓶取出，过200目筛，得载碘生物活性玻璃。
实施例4
将中空生物活性玻璃放入真空干燥烘箱内，100℃真空干燥1h；碘颗粒密闭研磨成细粉；按质量比1：1称取碘与生物活性玻璃，涡旋混合5～10min制成混合物；称取混合物1g注入5ml玻璃安瓿，充入N2气，熔封；将载药安瓶置于控温加热器中，设定温度70℃加热90min；将样品从安瓶取出，过200目筛，得载碘生物活性玻璃。
碘升华损失实验：称取同样重量的PVP-I和BAG-I，放于敞口烧瓶中，在 25±1℃恒温，进行碘的升华损失测试，发现BAG-I的升华损失明显减缓，6h的损失量仅为PVP-I损失量的25％左右，说明载碘生物活性玻璃具有较好的稳定性。
体外生物活性实验结果见附图1：生物活性玻璃富含硅、钙、磷，经体外矿化之前，样品在2θ＝27°左右存在较宽的弥散峰，说明矿化前样品是以非晶态或无定形态为主的固体物质。在SBF中矿化4h后，BAG表层的Ca2+和PO4 3-开始在颗粒表面Si-OH层上聚集，在2θ＝27°、32°、39°、46°和49°附近已经出现了羟基磷灰石晶体的特征峰(002)、(211)、(310)、(203)、和(213)等晶面，且峰型为明锐的尖峰。随着矿化时间延长到48h，上述峰强都有增强，这说明该生物活性玻璃在SBF溶液中能够迅速矿化，随着矿化时间的延长，羟基磷灰石在颗粒表面不断生长沉积，结晶越来越完全。羟基磷灰石层能够与人体的组织形成稳固的化学键合，诱导组织再生，因此体外矿化结果预示其具有较好的生理活性。而PVPI不含硅、钙、磷，不能生成羟基磷灰石层，不具有促进组织损伤愈合的能力。
体外抗菌实验结果如下：
本发明的载碘生物活性玻璃具有快速的体外矿化能力和良好的抑菌效果，可以直接以粉末的形式喷洒于伤口，也可以制备成多种形式用于伤口护理。
实施例5
取5g BAG-I与15g海藻酸钠均匀共混，用作外用消毒止血粉。临用时喷洒于伤口。
还可以添加壳聚糖、透明质酸等多糖成分。
实施例6
取1g BAG-I高速剪切分散于100ml矿物油中，用作外用消毒杀菌油膏。
基质还可以选择蜂蜡、凡士林等油性成分。
实施例7
取8g卡波姆、1g BAG-I高速剪切分散在100ml甘油中，混合分散均匀，用作外用消毒杀菌凝胶。
基质还可以选择聚乙烯醇、聚乙烯吡咯烷酮、羧甲基纤维素钠、羟丙甲纤维素、泊洛沙姆等水性成分；分散介质还可以选择丙二醇、PEG300、乙醇、异丙醇等多元醇。
实施例8
取8g BAG-I细粉(粒径<5～10μm)分散于16g肉豆蔻酸异丙酯中，加入 0.8g气相二氧化硅，均匀分散制成混悬液后，装入80ml气雾瓶中，压盖，充入 50g HFA134a，用作外用消毒杀菌气雾剂。
润湿剂还可以选择HLB 1～5的司盘85、油酸等表面活性剂。
Claims (6)
1.一种用于伤口护理的载碘生物活性玻璃，其特征在于其制备方法如下：
步骤一，以壳聚糖微球为模板，采用溶胶-凝胶-模板法制备中空生物活性玻璃；
步骤二，将中空生物活性玻璃放入真空干燥烘箱内，100℃真空干燥1h；
步骤三，采用密闭粉碎装置将碘制成180um以下的细粉；
步骤四，称取中空生物活性玻璃与碘，涡旋混合5～10min制成碘/生物活性玻璃混合物；
步骤五，将碘/生物活性玻璃混合物注入玻璃安瓿，充入N2气，熔封；
步骤六，将装药安瓿置于控温加热器中，设定温度50～70℃加热60～90min。
步骤七，将样品从安瓿取出，过200目筛，得载碘的生物活性玻璃BAG-I。
2.如权利要求1所述的用于伤口护理的载碘生物活性玻璃，其特征在于所述的步骤三中，中空生物活性玻璃与碘的质量比为1：0.1-1.5。
3.如权利要求1所述的用于伤口护理的载碘生物活性玻璃，其特征在于所述的步骤一中，中空生物活性玻璃的制备方法如下：
步骤一，把壳聚糖加入到体积百分数为0.1～5％的酸性水溶液中，配制质量百分比浓度为1～3％的壳聚糖水溶液，补加壳聚糖水溶液1～3倍体积量的乙醇。
步骤二，剧烈搅拌下，将正硅酸乙酯和硝酸盐加至上述乙醇水溶液中，调pH值至1～2，得到透明、均一的溶胶液A。
步骤三，将磷酸氢二氨、非离子亲水聚合物溶于水中，充分搅拌后，得到澄清透明的溶液B。
步骤四，将溶胶液A缓慢滴加至溶液B中，待其搅拌均匀后，向其中缓慢滴加碱性介质，溶液出现白色沉淀，继续滴加碱性介质，将pH值调为10-11。
步骤五，离心，冷冻干燥，马弗炉600～800℃高温热处理3h，得到中空生物活性玻璃粉末。
4.如权利要求3所述的用于伤口护理的载碘生物活性玻璃，其特征在于利用壳聚糖在碱性介质内不溶，当遇到碱性介质，形成凝聚/沉淀的性质，得到壳聚糖微球模板；所述的碱性溶液包括氨水、氢氧化钠、氢氧化钾中的一种或多种。
5.如权利要求4所述的用于伤口护理的载碘生物活性玻璃，其特征在于所述的酸性水溶液为醋酸、乳酸、硼酸、盐酸中的一种或多种。
6.权利要求1所述用于伤口护理的载碘生物活性玻璃用于制备伤口护理产品的应用。
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