CN112354000A - 明胶复方止血液及其制备方法 - Google Patents

明胶复方止血液及其制备方法 Download PDF

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CN112354000A
CN112354000A CN202011371269.2A CN202011371269A CN112354000A CN 112354000 A CN112354000 A CN 112354000A CN 202011371269 A CN202011371269 A CN 202011371269A CN 112354000 A CN112354000 A CN 112354000A
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欧阳林
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Ninth Hospital Of Joint Service Support Force Of Chinese Pla
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Abstract

本发明公开了明胶复方止血液及其制备方法，所述复方止血液由明胶、云南白药和血凝酶混合而成。本发明的止血液，以明胶、血凝酶为原料，辅以云南白药，一方面延长止血效能，另一方面兼具消炎、消肿、活血、怯瘀、止痛功效，还有利于后期创伤组织的康复。临床试验证明，应用明胶复方止血液可以达到创伤组织内毛细血管网和小静脉网水平的栓塞止血，有效靶向栓塞和保护脏器残存功能，优越于PVA和微弹簧圈在小动脉水平的栓塞效果。

Description

明胶复方止血液及其制备方法
技术领域
本发明涉及医用材料技术领域，具体涉及明胶复方止血液及其制备方法。
背景技术
对于创伤性骨折或脏器破裂大出血，现行一线治疗方法是应用介入技术进行血管腔内栓塞止血。介入栓塞止血方法已越来越得到国内、外临床的认可和推荐首选。栓塞材料有自体血凝块（短效栓塞剂），明胶海绵（中效栓塞剂），PVA、弹簧圈和胶体粘合栓塞剂（长效栓塞剂）。但是当前通过动脉途径给予的栓塞剂仅对控制动脉性出血有显著效果，而腹膜后、盆腔以及大腿等部位的深部软组织内广泛性挫裂伤造成的毛细血管网和静脉网出血还是常常令临床治疗束手无策，现有压迫法止血达不到效果、外科切开止血非常棘手，疗效难以预料和掌控。同样重要的是，出血部位的疼痛、急性止血后的瘀伤以及炎症反应等原发和继发并发症，均严重影响损伤的恢复。
现行临床介入治疗中，常用栓塞止血材料还有聚乙烯醇颗粒（PVA）、弹簧圈等永久性栓塞材料，这些材料在中、小动脉水平栓塞止血，难以微细化以到达和通过毛细血管网水平，在毛细血管和小静脉网水平发挥止血凝血效能。
综上所述，现临床针对深部软组织或脏器创伤出血的有效止血技术值得进一步研究创新。
发明内容
本发明的目的在于提供一种兼具持续的消炎、止痛、化瘀功效，促进损伤组织康复的明胶复方止血液及其制备方法，实现靶动脉给药达到组织内全血管系止血凝血的目的，
为实现上述目的，本发明采用以下技术方案：
明胶复方止血液，其由明胶、云南白药和血凝酶混合而成。
进一步地，所述明胶、云南白药和血凝酶的用量比为1±0.05g:1±0.05g:1U，优选为1g:1g:1U。
进一步地，所述明胶、云南白药均制作成粉剂，粒径小于100微米。
所述的明胶复方止血液的制备方法：将明胶、云南白药制作成粒径小于100微米的粉剂，然后将明胶粉、云南白药、血凝酶按比例搅拌混匀，无菌干燥保存。
本发明所述明胶复方止血液的主要成分为：明胶、血凝酶和云南白药，该三种成分的药理性能：（1）明胶：机械栓塞止血，中期栓塞剂，可降解吸收生物材料。同时，具有携载血凝酶和云南白药的功能。（2）血凝酶：白眉蛇或蝮蛇凝血酶原。（3）云南白药：止血、消炎、消肿、活血、怯瘀、止痛。
产品剂型：粉剂，瓶装（2g/瓶）。
所述明胶复方止血液的用法：依据临床病情选择用法和用量。（1）外用：开放性或暴露性创伤失血，直接将粉剂洒在创面或创口。（2）口服：呕血、吐血、便血、咯血，将粉剂温水送服，一次1/2瓶（1g），一日2次，16岁以下儿童减半，幼儿1/4量。（3）经导管血管腔内灌注：创伤性深部组织出血、咯血、胃肠出血等，将一瓶(2g)用20ml生理盐水溶解，再用20ml碘造影剂稀释，共40ml的混合溶液，灌注溶液进行栓塞过程中，末梢小动脉出现铸型是停止继续灌注的参考指证。
现行明胶栓塞剂为颗粒状，粒径大于100微米，通过微导管输送困难或不能，因此只能在较大动脉血管水平进行栓塞，导致栓塞效果靶向性差，深部或隐蔽组织出血、毛细血管和小静脉层面出血均难以有效止血；再者，较大动脉血管血流速大，容易把栓塞剂冲刷掉或带到其他部位、器官，造成病变部位栓塞不够而异位误栓并发症；血凝酶为快速促凝剂，急性期促凝效果好，可以较好的帮助深部或隐蔽组织出血、毛细血管和小静脉层面出血，但药效作用时间短，并且患者大量失血导致纤维蛋白原减少，导致血凝酶不能发挥作用；而本发明的止血液，以明胶、血凝酶为原料，辅以云南白药，一方面延长止血效能，另一方面兼具消炎、消肿、活血、怯瘀、止痛功效，还有利于后期创伤组织的康复。
本发明的止血材料可以经微导管输送到出血部位的动脉血管末梢，通过血流达到小-微动脉和组织内毛细血管-静脉网及血管周围组织及间隙，既可以快速控制复杂或隐蔽部位出血，又可以减小损伤控制性手术造成的继发损伤，还可以消炎、止痛、化瘀。
具体实施方式
实施例1
明胶复方止血液的制备方法；1）将明胶、云南白药、凝血酶均制作成粉剂，粒径小于100微米；2）将三种原料按比例机械混合（明胶粉1g，云南白药粉1g，血凝酶1U），无菌干燥保存。
实施例2
明胶复方止血液的制备方法；1）将明胶、云南白药、凝血酶均制作成粉剂，粒径小于100微米；2）将三种原料按比例机械混合（明胶粉1.05g，云南白药粉0.95g，血凝酶1U），无菌干燥保存。
实施例3
明胶复方止血液的制备方法；1）将明胶、云南白药、凝血酶均制作成粉剂，粒径小于100微米；2）将三种原料按比例机械混合（明胶粉0.95g，云南白药粉.05g，血凝酶1U），无菌干燥保存。
实施例4
明胶复方止血液的用法：依据临床病情选择用法和用量。（1）外用：开放性或暴露性创伤失血，直接将粉剂洒在创面或创口。（2）口服：呕血、吐血、便血、咯血，将粉剂温水送服，一次1/2瓶（1g），一日2次，16岁以下儿童减半，幼儿1/4量。（3）经导管血管腔内灌注：创伤性深部组织出血、咯血、胃肠出血等，将一瓶(2g)用20ml生理盐水溶解，再用20ml碘造影剂稀释，共40ml的混合溶液，灌注溶液进行栓塞过程中，末梢小动脉出现铸型是停止继续灌注的参考指证。
应用例
试验设计方案：A组人员急诊值班时采用实施例1制备的明胶复方止血液经动脉进行末梢栓塞治疗，B组人员急诊值班时采用PVA颗粒或微弹簧圈经动脉进行末梢栓塞治疗。
试验时间：自2019年9月1日至11月30日。
疗效评价指标：介入治疗术中止血效果（DSA造影诊断），术后再出血（CT增强扫描诊断），脏器梗死程度（CT增强扫描诊断，评估脏器功能保护程度的指标）。
试验结果：试验期间我院介入科共治疗13例腹盆深部软组织和脏器创伤性失血患者。A组治疗了6例（坠落肾破裂1例，车祸脾破裂和脾破裂各1例，撞击肝破裂2例，土方崩塌骨盆骨折合并盆后壁软组织广泛性挫裂伤1例），B组治疗了7例（坠落致单纯肾破裂1例和全身多处骨折合并盆后壁软组织广泛性挫裂伤1例，车祸骨盆骨折合并盆后壁软组织广泛性挫裂伤1例，摔倒和车祸致肝破裂各1例，挤压和暴力撞击脾破裂各1例）。DSA造影显示A组和B组的术中止血效果一致良好，没有明显差异。术后24小时CT增强扫描显示A组没有再出血表现，B组4例仍存在深部软组织挫裂伤区造影剂增强（造影剂泄漏，反映组织渗血，见于坠落致全身多处骨折合并盆后壁软组织广泛性挫裂伤1例，车祸骨盆骨折合并盆后壁软组织广泛性挫裂伤1例，摔倒和车祸致肝破裂各1例）。术后3天CT增强扫描显示A组5例实质脏器破裂患者（坠落肾破裂1例，车祸脾破裂和脾破裂各1例，撞击肝破裂2例）均达到实质脏器内段水平的栓塞止血，仅存在栓塞段包膜外炎症渗出反应；B组5例实质脏器破裂患者（坠落致单纯肾破裂1例，摔倒和车祸致肝破裂各1例，挤压和暴力撞击脾破裂各1例）均只达到（肝）叶动脉和全脏器（肾、脾）干动脉栓塞，介入术后辅助肾和脾外科全切除，进行叶动脉栓塞达到肝脏边缘炎症渗出明显。
试验结论：应用明胶复方止血液可以达到创伤组织内毛细血管网和小静脉网水平的栓塞止血，有效靶向栓塞和保护脏器残存功能，优越于PVA和微弹簧圈在小动脉水平的栓塞效果。
以上所述，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明披露的技术范围内，根据本发明的技术方案及其发明构思加以等同替换或改变，都应涵盖在本发明的保护范围之内。

Claims (5)

1.明胶复方止血液，其特征在于，其由明胶、云南白药和血凝酶混合而成。
2.根据权利要求1所述的明胶复方止血液，其特征在于，所述明胶、云南白药和血凝酶的用量比为1±0.05g:1±0.05g:1U。
3.根据权利要求2所述的明胶复方止血液，其特征在于，所述明胶、云南白药和血凝酶的用量比为1g:1g:1U。
4.根据权利要求1所述的明胶复方止血液，其特征在于，所述云南白药的粒径小于100微米。
5.如权利要求1-4任一项所述的明胶复方止血液的制备方法，其特征在于，其包括以下步骤：将明胶粉碎至粒径小于100微米的明胶粉，然后将明胶粉和云南白药、血凝酶按比例混匀，即得。
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