CN111388744B - 一种凝胶贮库及其制法与制备术后止血制剂的应用 - Google Patents
一种凝胶贮库及其制法与制备术后止血制剂的应用 Download PDFInfo
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Abstract
本发明涉及一种凝胶贮库及其制法与制备术后止血制剂的应用,属于生物医药技术领域。该凝胶贮库包括磷脂40‑55质量份、甘油酯40‑55质量份和助溶剂5‑20质量份;或者所述外层凝胶贮库包裹在内层凝胶贮库外部;所述外层凝胶贮库包括磷脂28‑38质量份、甘油酯62‑70质量份和助溶剂1‑8质量份,所述内层凝胶贮库包括磷脂40‑55质量份、甘油酯40‑55质量份和助溶剂5‑20质量份。优选地,所述凝胶贮库中还包括药物。本发明使用磷脂和甘油酯两种原料,通过混合,使凝胶前体遇水即可快速发生凝胶化,从而快速封闭出血点。双层贮库的内层凝胶具有凝胶化快速且强度高的特点,迅速封闭出血点,外层凝胶粘附性强,保证了整个凝胶体系不易脱落。
Description
技术领域
本发明属于生物医药技术领域,更具体地,涉及一种凝胶贮库及其制法与制备术后止血制剂的应用。
背景技术
出血是创伤发生之后最为常见的表现之一,但不可控的出血被认为是导致患者死亡的重要原因。传统的止血材料主要有纱布,绷带,止血带等。但是传统的止血方式是以牺牲远端组织供血为代价,很容易引起并发症。
之后,发展而来了很多新型的止血材料,例如沸石、海绵、高分子材料、无机材料、纳米材料等等。但是他们各自也有很多弊端。例如,沸石材料在止血的过程中会产生热量,有可能造成机体的损伤。无机材料无法在体内很好地被代谢清除等等。
同时,很多情况下,要求止血材料还要具有快速止血的性质,且不引起失血过多。纱布类超亲水的材料虽然可以有效止血,但是往往会造成失血过多。而凝胶类材料很多可以利用材料的粘着力直接封闭创面,是一种很有潜力的止血材料。但是很多凝胶材料合成困难、粘附力不强,容易脱落。因此,急需开发良好的适合止血的凝胶材料。
发明内容
本发明解决了现有凝胶止血材料不能实现快速止血,且粘附力不强而导致容易脱落的技术问题,提供了一种凝胶贮库,该凝胶贮库包括磷脂40-55质量份、甘油酯40-55质量份和助溶剂5-20质量份。本发明使用磷脂和甘油酯两种原料,通过混合,使凝胶前体遇水即可快速发生凝胶化,从而快速封闭出血点。
根据本发明的第一方面,提供了一种凝胶贮库,该凝胶贮库包括40-55质量份的磷脂、40-55质量份的甘油酯和5-20质量份的助溶剂。
优选地,所述凝胶贮库中还包括药物;
优选地,所述药物为止血药、消炎药或镇痛药。
优选地,所述磷脂为大豆卵磷脂或蛋黄卵磷脂;所述甘油酯为二油酸甘油酯、三油酸甘油酯或胆脂酰甘油酯;所述助溶剂为无水乙醇、甲醇、丙二醇或聚乙二醇。
按照本发明的另一方面,提供了一种凝胶贮库,包括外层凝胶贮库和内层凝胶贮库,所述外层凝胶贮库包裹在内层凝胶贮库外部;所述外层凝胶贮库包括28-38质量份的磷脂、62-70质量份的甘油酯和1-8质量份的助溶剂,所述内层凝胶贮库包括40-55质量份的磷脂、40-55质量份的甘油酯和5-20质量份的助溶剂。
优选地,所述外层凝胶贮库和/或内层凝胶贮库中还包括药物;
优选地,所述药物为止血药、消炎药或镇痛药。
按照本发明的另一方面,提供了任一所述的凝胶贮库的制备方法,包括以下步骤:
(1)将40-55质量份的磷脂、40-55质量份的甘油酯和5-20质量份的助溶剂进行混合,得到凝胶前体;
(2)将步骤(1)得到的凝胶前体装入注射筒内,然后推动凝胶前体,所述凝胶前体遇水凝胶化,即得到凝胶贮库。
优选地,所述磷脂、甘油酯和助溶剂混合后,还包括加入药物的步骤;
优选地,所述药物为止血药、消炎药或镇痛药。
按照本发明的另一方面,提供了任一所述的凝胶贮库的制备方法,括以下步骤:
(1)将28-38质量份的磷脂和62-70质量份的甘油酯进行混合,然后加入1-8质量份的助溶剂,得到外层凝胶前体,将40-55质量份的磷脂和40-55质量份的甘油酯,然后加入5-20质量份的助溶剂,得到内层凝胶前体;
(2)将步骤(1)得到的外层凝胶前体和内层凝胶前体分别装入双筒注射器的注射筒内,然后推动内层凝胶前体,所述内层凝胶前体遇水凝胶化,形成内层凝胶,再推动外层凝胶前体,使所述内层凝胶外部形成外层凝胶,即得到凝胶贮库。
优选地,所述外层凝胶前体和/或内层凝胶前体制备过程中,在加入助溶剂后,还包括加入药物的步骤;
优选地,所述药物为止血药、消炎药或镇痛药。
按照本发明的另一方面,提供了任一所述的凝胶贮库用于制备术后止血制剂的应用。
总体而言,通过本发明所构思的以上技术方案与现有技术相比,主要具备以下的技术优点:
(1)本发明使用磷脂和甘油酯两种原料,通过混合,使凝胶前体遇水即可快速发生凝胶化,从而快速封闭出血点。
(2)本发明中的凝胶贮库能实现快速止血,不会引起失血过多,无需以牺牲远端组织供血为代价,且不会引起并发症。止血的过程中不会产生热量,不会造成机体的损伤,且能够在体内很好地被代谢清除。
(3)本发明优选地,将不同比例组成的磷脂和甘油酯凝胶前体制备成双层凝胶用于术后止血;不同性质的凝胶前体制剂,采用双筒注射器,通过注射,得到双层凝胶药物贮库的效果,利用制剂遇水可快速凝胶化起到止血的作用。内层凝胶具有凝胶化快速且强度高的特点,迅速封闭出血点,外层凝胶粘附性强,保证了整个凝胶体系不易脱落。
(4)本发明优选地,凝胶贮库中还包括药物,药物可为止血药、消炎药或镇痛药,可以和止血药连用起到更好的止血效果,也可以联用镇痛药,通过缓释药物减轻患者痛苦,与消炎药联用预防炎症发生,促进伤口愈合。
附图说明
图1为本发明单层凝胶图。
图2为本发明双层凝胶图。
图3为本发明体外止血的过程。
图4为本发明体内止血的过程。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图及实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。此外,下面所描述的本发明各个实施方式中所涉及到的技术特征只要彼此之间未构成冲突就可以相互组合。
实施例1
一种可用于术后止血的凝胶贮库,由以下重量百分比的原料制备而成:50质量份大豆卵磷脂、50质量份二油酸甘油酯、10质量份无水乙醇,记为LG 50/50。
制备步骤如下:
S1:将磷脂50质量份、甘油酯50质量份和10质量份助溶剂,混合器上混合均匀,使磷脂和甘油酯完全溶解,得到凝胶前体;
S2:将步骤S1得到的凝胶前体装入注射器的注射筒内,然后推动凝胶前体至水中,所述凝胶前体遇水凝胶化,形成凝胶,即得到凝胶贮库,如图1所示。
实施例2
一种可用于术后止血的凝胶贮库,由以下重量百分比的原料制备而成:40质量份大豆卵磷脂、40质量份二油酸甘油酯、5质量份无水乙醇,记为LG 40/40。
制备步骤如下:
S1:将磷脂40质量份、甘油酯40质量份和5质量份助溶剂,混合器上混合均匀,使磷脂和甘油酯完全溶解,得到凝胶前体;
S2:将步骤S1得到的凝胶前体装入注射器的注射筒内,然后推动凝胶前体至水中,所述凝胶前体遇水凝胶化,形成凝胶,即得到凝胶贮库。
实施例3
一种可用于术后止血的凝胶贮库,由以下重量百分比的原料制备而成:55质量份大豆卵磷脂、55质量份二油酸甘油酯、20质量份无水乙醇,记为LG 55/55。
制备步骤如下:
S1:将磷脂55质量份、甘油酯55质量份和20质量份助溶剂,混合器上混合均匀,使磷脂和甘油酯完全溶解,得到凝胶前体;
S2:将步骤S1得到的凝胶前体装入注射器的注射筒内,然后推动凝胶前体至水中,所述凝胶前体遇水凝胶化,形成凝胶,即得到凝胶贮库。
实施例4
一种凝胶贮库,包括外层凝胶贮库和内层凝胶贮库,所述外层凝胶贮库包裹在内层凝胶贮库外部;所述外层凝胶贮库包括磷脂35质量份、甘油酯65质量份和助溶剂5质量份,所述内层凝胶贮库包括磷脂45质量份、甘油酯45质量份和助溶剂10质量份。
制备步骤如下:
S1:将磷脂35质量份和甘油酯65质量份进行混合,然后加入5质量份助溶剂,得到外层凝胶前体,将磷脂45质量份和甘油酯45质量份,然后加入10质量份助溶剂,得到内层凝胶前体;
S2:将步骤(1)得到的外层凝胶前体和内层凝胶前体分别装入双筒注射器的注射筒内,然后推动内层凝胶前体至水中,所述内层凝胶前体遇水凝胶化,形成内层凝胶,再推动外层凝胶前体,使所述内层凝胶外部形成外层凝胶,即得到凝胶贮库,如图2所示。
实施例5
一种凝胶贮库,包括外层凝胶贮库和内层凝胶贮库,所述外层凝胶贮库包裹在内层凝胶贮库外部;所述外层凝胶贮库包括磷脂28质量份、甘油酯64质量份和助溶剂8质量份,所述内层凝胶贮库包括磷脂40质量份、甘油酯55质量份和助溶剂5质量份。
制备步骤如下:
S1:将磷脂28质量份和甘油酯64质量份进行混合,然后加入8质量份助溶剂,得到外层凝胶前体,将磷脂40质量份和甘油酯55质量份,然后加入5质量份助溶剂,得到内层凝胶前体;
S2:将步骤(1)得到的外层凝胶前体和内层凝胶前体分别装入双筒注射器的注射筒内,然后推动内层凝胶前体至水中,所述内层凝胶前体遇水凝胶化,形成内层凝胶,再推动外层凝胶前体,使所述内层凝胶外部形成外层凝胶,即得到凝胶贮库。
实施例6
一种凝胶贮库,包括外层凝胶贮库和内层凝胶贮库,所述外层凝胶贮库包裹在内层凝胶贮库外部;所述外层凝胶贮库包括磷脂37质量份、甘油酯62质量份和助溶剂1质量份,所述内层凝胶贮库包括磷脂52质量份、甘油酯40质量份和助溶剂8质量份。
制备步骤如下:
S1:将磷脂37质量份和甘油酯62质量份进行混合,然后加入1质量份助溶剂,得到外层凝胶前体,将磷脂52质量份和甘油酯40质量份,然后加入8质量份助溶剂,得到内层凝胶前体;
S2:将步骤(1)得到的外层凝胶前体和内层凝胶前体分别装入双筒注射器的注射筒内,然后推动内层凝胶前体至水中,所述内层凝胶前体遇水凝胶化,形成内层凝胶,再推动外层凝胶前体,使所述内层凝胶外部形成外层凝胶,即得到凝胶贮库。
实施例7
取含有1%肝素钠的动物新鲜血液(体积为10-15IU对应1ml血液)各100ul,分别加入12个西林瓶中。对照组不做任何处理。LG 35组加入300ul的35/65的LG。LG 50组加入300ul的50/50的LG。LG 35+LG 50组加入各150ul的LG前体。分别于30s,2min,5min将每组的其中一个西林瓶上下颠倒,并拍摄照片。可见,30s时LG 50绝大部分血可以止住,LG35+LG50也止住了接近一半的血液量,LG 35也有一定程度的止血效果。2min时,LG 50和LG 35+LG50基本可以完全止住血,LG 35止住了大部分血液。5min时,三种凝胶都可以完全止血,血液凝固程度较高,并且凝胶也不易脱落。如图3所示。
实施例8
将正常的小鼠麻醉,使其保持生命体征。取出其部分肝脏,用利器制造出血点。1min后小鼠肝脏有一定程度的出血,此时利用双筒注射器首先注射LG 50/50的凝胶,利用此比例凝胶具有凝胶化快速且强度高的特点,迅速封闭出血点。接着,立即注射LG 35/65的凝胶,进一步封闭出血点,且此比例凝胶粘附性强,保证了整个凝胶体系不易脱落。在接下来的30s-4min之内观察小鼠的出血状况,小鼠基本上不再出血。接着,在注射凝胶4分钟之后,将凝胶移除,可见创口已经完全止住流血。如图4所示。
本领域的技术人员容易理解,以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。
Claims (7)
1.一种凝胶贮库,其特征在于,包括外层凝胶贮库和内层凝胶贮库,所述外层凝胶贮库包裹在内层凝胶贮库外部;所述外层凝胶贮库包括28-38质量份的磷脂、62-70质量份的甘油酯和1-8质量份的助溶剂,所述内层凝胶贮库包括40-55质量份的磷脂、40-55质量份的甘油酯和5-20质量份的助溶剂。
2.如权利要求1所述的凝胶贮库,其特征在于,所述外层凝胶贮库和/或内层凝胶贮库中还包括药物。
3.如权利要求2所述的凝胶贮库,其特征在于,所述药物为止血药、消炎药或镇痛药。
4.如权利要求1-3任一所述的凝胶贮库的制备方法,其特征在于,包括以下步骤:
(1)将28-38质量份的磷脂和62-70质量份的甘油酯进行混合,然后加入1-8质量份的助溶剂,得到外层凝胶前体,将40-55质量份的磷脂和40-55质量份的甘油酯,然后加入5-20质量份的助溶剂,得到内层凝胶前体;
(2)将步骤(1)得到的外层凝胶前体和内层凝胶前体分别装入双筒注射器的注射筒内,然后推动内层凝胶前体,所述内层凝胶前体遇水凝胶化,形成内层凝胶,再推动外层凝胶前体,使所述内层凝胶外部形成外层凝胶,即得到凝胶贮库。
5.如权利要求4所述的凝胶贮库的制备方法,其特征在于,所述外层凝胶前体和/或内层凝胶前体制备过程中,在加入助溶剂后,还包括加入药物的步骤。
6.如权利要求5所述的凝胶贮库的制备方法,其特征在于,所述药物为止血药、消炎药或镇痛药。
7.如权利要求1-3任一所述的凝胶贮库用于制备术后止血制剂的应用。
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