CN113952355A - 一种用于止血抗炎的中药纳米复合物及其制备方法 - Google Patents
一种用于止血抗炎的中药纳米复合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于止血抗炎的中药纳米复合物及其制备方法，本发明的中药纳米复合物是由羧甲基壳聚糖、白芨多糖和三七素复合制备而成。本发明首先经酶解反应制备羧甲基壳聚糖，然后与白芨多糖、三七素混合酸化处理，中和、洗涤、干燥、灭菌，得到中药纳米复合物，该材料具有止血和粘附作用，可形成即时凝胶，粘附创面机械性封堵血管破口，同时此物理屏障可以隔离伤口，起到一定的防粘连作用，该材料中含有白芨、三七成分，本身具有止血、抗菌、消肿生肌的作用，羧甲基壳聚糖是一种重要的水溶性壳聚糖衍生物，有许多医学功效，如促进创面愈合、止血、抑制瘢痕、镇痛和抑菌作用，这种中药纳米复合物无毒无刺激，并同时具有止血和抗菌双重作用。
Description
技术领域
本发明涉及中药制剂技术领域，具体的说涉及一种用于止血抗炎的中药纳米复合物及其制备方法。
背景技术
糖尿病足是一种因糖尿病血管病变、神经病变和感染等因素影响，导致糖尿病患者足部组织被破坏的病变。若不及时采取有效措施，将会引起足部溃烂和肢端坏死，严重时甚至需要截肢。近年来研究发现中药纳米复合物可以有效干预和治疗糖尿病足。羧甲基壳聚糖是一种重要的水溶性壳聚糖衍生物，有许多医学功效，如促进创面愈合、止血、抑制瘢痕、镇痛和抑菌作用，是创口用纳米复合物的优良载体。
国内市场尚无针对糖尿病足的家用修复护理产品，现有的修复护理产品效果不尽人意且副作用大，无法满足糖尿病足患者的需求。
因此，提供一种新的中药纳米复合物给药方式提高治疗效果是本领域亟待解决的问题。
发明内容
有鉴于此，本发明提供了一种用于止血抗炎的中药纳米复合物及其制备方法。
本发明的目的之一在于提供一种用于止血抗炎的中药纳米复合物，主要由以下质量百分比含量的原料制备得到：羧甲基壳聚糖5-99％，以及，白芨多糖1-95％、三七素3-95%。
优选的，所述羧甲基壳聚糖50-90％，以及，所述白芨多糖10-50％、三七素15-50%；优选地，所述羧甲基壳聚糖60-90％，以及，所述白芨多糖20-50％、三七素25-50%；更优选地，所述羧甲基壳聚糖70％，以及，所述白芨多糖40％，三七素43%。
优选的，所述羧甲基壳聚糖的制备过程如下：将壳聚糖悬浮于异丙醇溶液中并加入10 M氢氧化钠，再逐滴滴加溶于异丙醇中的氯乙酸，然后加入乙醇终止反应，过滤洗涤并透析后冻干，得到羧甲基壳聚糖。
优选的，所述中药纳米复合物的性状为粉状。
本发明还提供了一种用于止血抗炎的中药纳米复合物制备方法，包括以下步骤：将羧甲基壳聚糖、白芨多糖和三七素进行混合酸化处理，得到中药纳米复合物。
优选的，所述酸化的反应时间为4-30h，优选为8-24h，更优选为16h。
优选的，所述混合酸化处理的PH值为2-3；所述混合酸化处理的温度为30-50℃，所述混合酸化处理的时间为0.5-4h。优选地，所述干燥包括鼓风干燥、真空干燥或真空冷冻干燥；优选地，干燥温度为30-60℃，优选为35-50℃；优选地，所述灭菌方式为辐射灭菌。
本发明提供的一种用于止血抗炎的中药纳米复合物及其制备方法至少包括如下有益效果：
（1）本发明的中药纳米复合物主要由白芨多糖、三七粉和羧甲基壳聚糖复合制备而成，中药纳米复合物产品所具有的微孔结构可以快速吸附血液中的水，加速凝血。由于白芨多糖的加入，不仅可以缩短凝血时间，有效止血，而且形成凝胶的粘附性增强，有效封堵出血创面；白芨多糖的抗菌作用可以通过抑制脂质过氧化反应来促进创面修复。该材料能迅速有效止血的同时，可预防伤口染菌感染，解决了目前糖尿病足不易愈合的问题，因此，中药纳米复合物将是一种理想的止血抗菌材料；
（2）本发明的中药纳米复合物，纯植物来源，降解速度较快，提高了患者的安全性；
（3）本发明的中药纳米复合物的抑菌率为50％-100％。
具体实施方式
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
一种用于止血抗炎的中药纳米复合物，主要由以下质量百分比含量的原料制备得到：羧甲基壳聚糖5-99％，以及，白芨多糖1-95％、三七素3-95%。
进一步的，羧甲基壳聚糖50-90％，以及，白芨多糖10-50％、三七素15-50%；优选地，羧甲基壳聚糖60-90％，以及，白芨多糖20-50％、三七素25-50%；更优选地，羧甲基壳聚糖70％，以及，白芨多糖40％，三七素43%。
进一步的，羧甲基壳聚糖的制备过程如下：将壳聚糖悬浮于异丙醇溶液中并加入10 M氢氧化钠，再逐滴滴加溶于异丙醇中的氯乙酸，然后加入乙醇终止反应，过滤洗涤并透析后冻干，得到羧甲基壳聚糖。
进一步的，中药纳米复合物的性状为粉状。
本发明还提供了一种用于止血抗炎的中药纳米复合物制备方法，包括以下步骤：将羧甲基壳聚糖、白芨多糖和三七素进行混合酸化处理，得到中药纳米复合物。
进一步的，酸化的反应时间为4-30h，优选为8-24h，更优选为16h。
进一步的，混合酸化处理的PH值为2-3；混合酸化处理的温度为30-50℃，混合酸化处理的时间为0.5-4h。优选地，干燥包括鼓风干燥、真空干燥或真空冷冻干燥；优选地，干燥温度为30-60℃，优选为35-50℃；优选地，灭菌方式为辐射灭菌。
试验例1 抑菌性实验
分别取试验例、比较例和上市产品样品，按GB15979-2002附录C中C4项规定的方法进行抑菌试验，作用时间为20min。将试验菌24h斜面培养物用PBS洗下，制成菌悬液(要求的浓度为：用100μL滴于对照样品，回收菌数为1×104～9×104CFU/m L)。取被试样品(0.75g)和对照样品(与试样同质材料，同等质量，但不含抗菌材料，且经灭菌处理)各4件(置于灭菌平皿内)或4管。取上述菌悬液，分别在每个被试样液和对照样液上或滴加100μL，均匀涂布/混合，开始计时，作用2、5、10、20min，用无菌镊分别将样液(0.5m L)投入含5m LPBS的试管内，充分混匀，作适当稀释，然后取其中2-3个稀释度，分别吸取0.5m L，置于两个平皿，用凉至40-45℃的营养琼脂培养基(细菌)或沙氏琼脂培养基(酵母菌)15ml作倾注，转动平皿，使其充分均匀，琼脂凝固后翻转平板，35±2℃培养48h(细菌)或72h(酵母菌)，作活菌菌落计数。试验重复3次，按下式计算抑菌率：
X4＝(A-B)/A×100％
式中：X4——抑菌率，％；
A——对照样品平均菌落数；
B——被试样品平均菌落数；
抑菌种类：金黄色葡萄球菌(CMCC(B)26003)、白色念珠菌(CMCC(F)98001)、大肠埃希菌(CMCC(B)44102)、枯草芽孢杆菌(CMCC(B)63501)；评价标准：菌种的抑菌率≥50％-90％，产品有抑菌作用，抑菌率≥90％，产品有较强抑菌作用。
取实施例1样品，按照上述方法检测抑菌性能，得到样品对金黄色葡萄球菌抑菌、白色念珠菌、大肠埃希菌的抑菌率均为100%，对枯草芽孢杆菌抑菌率为97%。
尽管上面已经示出和描述了本发明的实施例，可以理解的是，上述实施例是示例性的，不能理解为对本发明的限制，本领域的普通技术人员在本发明的范围内可以对上述实施例进行变化、修改、替换和变型。
Claims (8)
1.一种用于止血抗炎的中药纳米复合物，其特征在于，主要由以下质量百分比含量的原料制备得到：羧甲基壳聚糖5-99％，以及，白芨多糖1-95％、三七素3-95%。
2.根据权利要求1所述的一种用于止血抗炎的中药纳米复合物，其特征在于，所述羧甲基壳聚糖50-90％，以及，所述白芨多糖10-50％、三七素15-50%；优选地，所述羧甲基壳聚糖60-90％，以及，所述白芨多糖20-50％、三七素25-50%；更优选地，所述羧甲基壳聚糖70％，以及，所述白芨多糖40％，三七素43%。
3.根据权利要求1所述的一种用于止血抗炎的中药纳米复合物，其特征在于：所述羧甲基壳聚糖的制备过程如下：将壳聚糖悬浮于异丙醇溶液中并加入10 M氢氧化钠，再逐滴滴加溶于异丙醇中的氯乙酸，然后加入乙醇终止反应，过滤洗涤并透析后冻干，得到羧甲基壳聚糖。
4.根据权利要求1-3任一项所述的一种用于止血抗炎的中药纳米复合物，其特征在于，所述中药纳米复合物的性状为粉状。
5.根据权利要求1-4任一项所述的一种用于止血抗炎的中药纳米复合物，其特征在于，其制备方法包括以下步骤：将羧甲基壳聚糖、白芨多糖和三七素进行混合酸化处理，得到中药纳米复合物。
6.根据权利要求5所述的一种用于止血抗炎的中药纳米复合物制备方法，其特征在于，所述酸化的反应时间为4-30h，优选为8-24h，更优选为16h。
7.根据权利要求6所述的一种用于止血抗炎的中药纳米复合物制备方法，其特征在于，所述混合酸化处理的PH值为2-3；所述混合酸化处理的温度为30-50℃，所述混合酸化处理的时间为0.5-4h。
8.优选地，所述干燥包括鼓风干燥、真空干燥或真空冷冻干燥；优选地，干燥温度为30-60℃，优选为35-50℃；优选地，所述灭菌方式为辐射灭菌。
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