CN111203048A - 一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用 - Google Patents
一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用 Download PDFInfo
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Abstract
一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用，采用纳米黄荆为主要灭菌原料，利用生物工程技术，研制一种纳米中药活性强的灭菌胶体状生物溶液，将胶体状生物溶液与吸水性强、透气性好的无纺布（无纺纸）复合成一种载有纳米中药成分的自行灭菌净化生物膜，广泛应用于呼吸道传染性疾病流行，微生物病原体飞沫传播、接触传播和气溶胶传播时期的医院、家庭、公共场所，卫生防护需求的一次性耗材：口罩、帽子、检查床单、鞋套、隔离衣、隔离帘子、窗纱、手套、门帘、空调和换气扇的过滤网。解决医疗防护耗材安全性差、低频率使用、高成本消耗和环境污染严重的问题；解决空气过滤网对病原体有效阻挡能力的安全性难题。
Description
技术领域
本发明属于天然中药材生物工程提取有效分子成分载体络合及生物复合技术领域。具体涉及天然中药生物工程提取纳米成分载体叠加提高生物活性的应用技术；纳米中药制备胶体状生物灭菌溶液技术；胶体状生物灭菌溶液和无纺布/无纺纸复合载有生物膜界面具有自行灭菌净化的生物工程技术；生物膜渗透压干预膜面吸附微生物病原体趋向性和滞留作用可控性原理的生物工程技术，以及自行灭菌净化生物膜和聚氯乙烯/聚苯乙烯复合成过滤网膜的复合技术。基于涉及技术的基础上研制一种新型纳米中药成分自行灭菌净化生物膜的无纺布（无纺纸），应用于防御病原体（细菌、病毒等）污染接触、病原体造成空气污染和气溶胶形成传播的环境空气净化和医疗防护范围及使用方法。
背景技术
中药材是自然生态链衍生的产物，具有生药和熟药应用之分，传统性中药炮制（醋、蜜、酒、盐、火等炙法）的方法，能够提高中药材的有效成分效价，除了采用水煎、粉碎、水浸挤压、蒸馏升华浓缩，制备成为水剂、冲剂、丸剂、片剂、胶囊、膏剂、乳剂、针剂外，还制备成为香、药条、香炉燃料，应用于空气净化和空气消毒。
现代中药材提取制备的应用技术可分为：
1）中药材纳米微粒应用技术，采用气流磨对中药材进行颗粒粉碎成为纳米微粒应用。
2）中药材萃取应用技术，中药材经过炮制或者不炮制后，采用化学方法和物理方法，进行中药有效成分提取，这种方法常造成多元化同类衍生物产生，限制了中药应用范围。
3）中药材生物发酵应用技术，在特定条件下对天然中药材采用生物发酵，该方法会产生非天然成分，影响其天然成分的活性。
4）中药材生物工程应用技术，采用在控制外界条件的干扰下，进行中药材生物破壁，实现中药材有效成分和蛋白质、胶质体、纤维素及钙质的络合体生物分离，结晶析出得到分子单体水平的结晶成分，其有效提取达到纳米级应用水平，有效提高中药材的药物效果和使用范围的扩展，达到中药材国际化、标准化的临床应用。
目前医疗使用的各种防护设施和空气净化过滤网，通过物理隔离病原体的方法，容易造成污染，使用时间短、频率次数低、成本高，使用时安全性低、防护范围狭窄，使用后对环境严重污染。在呼吸道和消化道传染性疾病流行期，不能达到预定的防御保护效果，在毒性强、繁殖快的病原体传播时，防御保护不理想，无法有效控制疫情扩散。
发明内容
本发明一种纳米中药自行灭菌净化生物膜的无纺布制备及应用，采用纳米黄荆为主要灭菌原料，利用生物工程技术，研制一种天然纳米中药活性强的灭菌胶体状溶液，将胶体溶液与吸水性强、透气性好的无纺布（无纺纸）复合成一种载有纳米中药成分的自行灭菌净化生物膜，解决医疗防护耗材安全性差、低频率使、高成本消耗和环境污染严重的问题；解决空气过滤网对病原体有效阻挡能力弱的难题。
1.本发明纳米原料为：
1）纳米壳聚糖(纯度为90.3%)为生物载体原料，具有生物络合、抑菌、控释作用，其制备和应用，见发明专利：一种制备壳聚糖的制备方法（专利号：ZL97 1 08700.8）（图5）；发明专利：纳米钙塑料生物降解复合树脂及其制备和使用方法（专利号：ZL 20150682.X）（图6），原料企业编码：pc006。
2）纳米果胶(纯度为95.2%)为生物载体原料，具有生物控释、抑制、粘附作用，原料企业编码：pc007。
3)纳米天然黄荆(纯度为86.4%)，具有对广谱病原体灭菌性，中药黄荆源于自然，分布广泛，原料来源丰富。千年来民间通过燃烧黄荆产生烟雾进行消除瘟疫、驱除瘴气和驱蚊，东南亚民间中医称为中药抗菌之王，黄荆无毒性、易挥发，人、动物皆可食用，将生物工程提取纯度86.4%的纳米黄荆，按照依据临床最大使用量和其它中药成分混合成为维康粉，进行急毒性试验和人体每日15克口服一个月临床应用观察，均验证无毒、无过敏、无不良反应，原料企业编码：pc008。
（上述3种原料2015年前由陕西省康维生物工程研究所提供，2015年后由西安普草瑞珊生物科技有限责任公司提供）
4）氯化钠晶体采用市面食盐（中盐榆林盐化有限公司），生物膜渗透压调节剂、脱水抑制剂。
5）医用碘伏（上海利康消毒高科技有限公司），胶体溶液的防腐剂、表面活性灭菌剂。
2. 本发明原料使用量，按照百分比浓度比例及范围：90.3%纳米壳聚糖1-5%、95.2%纳米果胶30-35%、86.4%纳米黄荆30-35%、50%氯化钠溶液25-30%和医用碘伏溶液10-15%，制备成为灭菌性、缓释性生物胶体状溶液。
3. 本发明原料载有膜，采用温州市龙湾永中同峰公司市面销售的吸水性强和透气性高的无纺布/无纺纸。
一种载有纳米中药自行灭菌净化生物膜的胶体状溶液说明
本发明一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用，其生物胶体状溶液的PH值为6.5-7.5，呈深棕红、透明悬浮胶体状溶液，具有质粘，微挥发性，无毒、无刺激、无腐蚀性，密封常温、避光条件下自然贮存7个月有效，有少许微量沉淀出现，使用时充分震荡即可使用，按照0.2±0.1g/cm2的量喷洒在吸水性强的无纺布（无纺纸）上，1分钟后置于低于20℃或者低温冻干干燥，进行制备自行灭菌净化的生物复膜。
一种载有纳米中药自行灭菌净化生物膜的无纺布/无纺纸机制原理：
纳米壳聚糖中药载体，能提高中药成分活性，对病原体具有强吸附性和抑菌性；纳米果胶对病原体具有吸附性，对中药成分具有缓释性，对药物和载有辅料具有较强吸附性，能够有效控制病原体移动和防止药物成分挥发；纳米黄荆对微生物病原体，具有非特异性快速灭活功能。纳米黄荆、纳米壳聚糖和纳米果胶混合后发生载体络合，形成载体络合物，对微生物病原体具有较强广谱灭菌作用，有效降低中药络合体有效成分的挥发；氯化钠能够保证灭菌生物膜界面渗透压的稳定性，有效促进生物膜周围的病原体快速向生物膜移动，其原理为生物膜处于高渗透压状态，生物膜吸收周围水分，造成病原体依附水分移动，从而有效的将病原体吸附在生物膜界面上，同时氯化钠能致病原体渗透性脱水，导致病原体活性减弱及繁殖性抑制；医用碘伏溶液，与纳米壳聚糖和纳米果胶形成载体络合物，能使生物膜长期处于净化状态。依据上述原料成分功能，采用纳米中药成分多功能叠加络合，使生物膜界面较长时期处于一个生物活性较强的灭菌净化状态，使生物膜界面自行灭菌净化的安全性、可靠性、时间性（使用7-30天左右）得到保证。
一种载有纳米中药自行灭菌净化生物膜的无纺布/无纺纸的应用范围：
广泛应用于呼吸道传染性疾病流行，微生物病原体通过飞沫传播、接触传播和气溶胶传播时期的医院、家庭、公共场所等，卫生防护需求的一次性耗材：口罩、帽子、检查床单、鞋套、隔离衣、隔离帘子、窗纱、手套、门帘、空调和换气扇的过滤网等。
一种载有纳米中药自行灭菌净化生物膜的无纺布/无纺纸制备的具体试验方法：
试验方法1
按质量百分比浓度制备，在200ml塑料容器中，依次置入90.3%纳米壳聚糖5克、95.2%纳米果胶30克、86.4%纳米黄荆35克、50%氯化溶液25克、医用碘伏溶液5克混合后，调节PH值为6.5，置于密闭式超声波发生器（施德加湿器改成为密闭式）震荡溶解10分钟后，按照0.3g/cm2喷洒吸水性无纺布，1分钟后置于19℃室温自然干燥，得到一种载有纳米中药自行灭菌净化生物膜的无纺布。
试验方法2
按质量百分比浓度制备，在200ml塑料容器，置入90.3%纳米壳聚糖1克、95.2%纳米果胶34克、86.4%纳米黄荆30克、50%氯化溶液30克、医用碘伏溶液5克混合后，调节PH值为6.4，置于密闭式超声波发生器（施德加湿器改成为密闭式），进行震荡溶解10分钟后，按照0.3g/cm2喷洒吸水性无纺布，1分钟后置于15℃室温自然干燥，得到一种载有纳米中药自行灭菌净化生物膜的无纺布。
试验方法3
按质量百分比浓度制备，在200ml塑料容器，置入90.3%纳米壳聚糖4克、95.2%纳米果胶31克、86.4%纳米黄荆34克、50%氯化溶液21克、医用碘伏溶液10克混合后，调节PH值为6.8，置于密闭式超声波发生器（施德加湿器改成为密闭式），进行震荡溶解10分钟后，按照0.3g/cm2喷洒吸水性无纺纸，1分钟后置于4℃室温自然干燥，得到一种载有纳米中药自行灭菌净化生物膜的无纺纸。
试验方法4
按质量百分比浓度制备，在200ml塑料容器，置入90.3%纳米壳聚糖3克、95.2%纳米果胶35克、86.4%纳米黄荆32克、50%氯化溶液25克、医用碘伏溶液5克混合后，调节PH值为7.0，置于密闭式超声波发生器（施德加湿器改成为密闭式），进行震荡溶解10分钟后，按照0.1g/cm2喷洒吸水性无纺布，1分钟后置于-3℃冰箱干燥，得到一种载有纳米中药自行灭菌净化生物膜的无纺布。
试验方法5
按质量百分比浓度制备，在200ml塑料容器，置入90.3%纳米壳聚糖2克、95.2%纳米果胶33克、86.4%纳米黄荆35克、50%氯化溶液20克、医用碘伏溶液10克混合后，调节PH值为7.5，置于密闭式超声波发生器（施德加湿器改成为密闭式），进行震荡溶解10分钟后，按照0.2g/cm2喷洒吸水性无纺纸，1分钟后置于-10℃低温干燥，得到一种载有纳米中药自行灭菌净化生物膜的无纺纸。
一种载有纳米中药自行灭菌净化生物膜的无纺布/无纺纸的应用范围及使用方法：
1.一次性口罩，制作分成三层，外层采用透气性好、不吸收水分的无纺布，中间层为自行灭菌净化生物膜无纺布（无纺纸）,内层为透气性低、吸水性高无纺布（无纺纸），医疗性使用时间为 1-3天，非医疗性使用7-14天。
2.一次性帽子、检查床床单、鞋套、隔离衣，制作分成三层，外层采用透气性好、不吸收水分的无纺布，中间层为自行灭菌净化生物膜无纺布（无纺纸）,内层无纺布（无纺纸），医疗性使用时间为 7-14天，非医疗性使用14-30天。
3.一次性 隔离帘子、窗纱、手套、门帘，制作分成三层，外层采用无纺布（无纺纸），中间层为自行灭菌净化生物膜无纺布（无纺纸）,内层无纺布（无纺纸），医疗性使用时间为7-14天，非医疗性使用14-30天。
4、一次性空气净化复合膜，将自行灭菌净化生物膜（无纺布）和网状聚氯乙烯或者聚丙乙烯复合成为一种网膜，制作成为空调、换气扇进气口或出气口以及窗纱防护膜，可以进行空气净化，医疗性使用时间为 7-14天，非医疗性使用14-30天。
本发明检验报告及中药原料提供单位：
1.本发明涉及利用生物工程技术，提取天然中药材分子有效成分的纳米中药原料，进行过急毒测试。1997年2月28日陕西康维生物工程研究所，按照临床应用最大剂量将96.4%纳米天然青蟹肌醇、97.5%纳米天然牛磺酸、90.2%纳米壳聚糖、86.4%纳米黄荆，按照1：1.5：0.5:1比例混合后的白色粉末（维康素粉），在陕西省药品检测所进行检测。结论为：本品参照((中药新药指南))检验，该受试物在本实验条件下，测得对实验小鼠的最大耐受量大于35.2g/kg. （图1）。
2.本发明涉及灭菌胶体性溶液，于2014年3月26日年，由陕西省康维生物工程研究所，按照科申报基金要求，药品名称定为维康素液进行检测，委托陕西省微生物研究所分析检测中心，进行检查试验结果为：
（图2、图3、图4）
3.本发明专利采用天然中药材生物提出的所有纳米原料。2015年前由陕西康维生物工程研究所生产销售（查询：www.zjmwjw.com），2015年至今由西安普草瑞珊生物科技有限责任公司提供（查询：15929926021）。
4.壳聚糖原料，发明专利。（图5）
5.纳米壳聚糖原料应用，发明专利。（图6）
附图说明
图1是维康素粉急毒试验报告
图2是维康素液检测报告
图3是维康素液检测报告
图4是维康素液检测报告
图5是壳聚糖原料发明专利
图6是纳米壳聚糖原料应用发明专利。
Claims (7)
1.一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用，其特征在于，以纳米壳聚糖、纳米果胶、纳米黄荆为原料，溶于氯化钠溶液中，制备成灭菌胶体性溶液，定量喷洒在兼具吸水性和透气性的无纺布（无纺纸）上，置于低于20℃或者低温冻干干燥，制备成为一种具有自行灭菌净化的生物复合膜，该生物膜能够有效吸附病原体,并且快速灭菌使其处于自行净化状态。
2.根据权利要求1所述的一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用，其特征在于纳米中药有效成分，能够达到标准化、工艺产业化，配制涉及原料的纯度和百分比范围为：90%（±10%）纳米壳聚糖1-5%、95%（±5%）纳米果胶30-35%、86%（±10%）纳米黄荆30-35%、50%（±10%）氯化钠溶液25-30%和医用碘伏溶液5-10%。
3.根据权利要求1所述的一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用，其特征在于，所述灭菌胶体性溶液，按照0.2±0.1g/cm2的量喷洒在吸水性强的无纺布（无纺纸）上。
4.根据权利要求1所述的一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用，其特征在于，所述灭菌胶体性溶液的PH值为6.5-7.5；所使用的无纺布（无纺纸）具有吸水性、透气性、无毒性和无异味刺激性；在低于20℃或者低温冻干干燥条件下进行，制备成自行灭菌净化生物膜。
5.根据权利要求1所述的一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用，其特征在于，所述纳米有效成分，必须是天然中药生物工程提取的纳米晶型成分。
6.根据权利要求1所述的一种载有纳米中药自行灭菌净化生物膜的无纺布制备及应用，其特征在于，所述的应用范围，适用于医疗防护用品（口罩、帽子、隔离衣、床单、手套、鞋套）、空气净化设备的过滤膜、一次性窗纱、窗帘以及门帘等。
7.根据权利要求6所述的使用方法，其特征在于，该自行灭菌净化生物膜用于一次性口罩、隔离衣、隔离帘子、帽子、床单、手套和鞋套的中间层；该生物膜经过和聚氯乙烯/聚苯乙烯塑料网复合成网膜，应用于窗纱的内侧，可替换空调和换气扇的空气过滤网等。
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