CN108938614A - 一种治疗开放性损伤的复合物及其制备方法和应用 - Google Patents
一种治疗开放性损伤的复合物及其制备方法和应用 Download PDFInfo
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- CN108938614A CN108938614A CN201710349180.8A CN201710349180A CN108938614A CN 108938614 A CN108938614 A CN 108938614A CN 201710349180 A CN201710349180 A CN 201710349180A CN 108938614 A CN108938614 A CN 108938614A
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Abstract
本发明属于医药技术领域，具体涉及一种治疗开放性损伤的复合物及其制备方法和应用。该治疗开放性损伤的复合物，由如下原料制成：胍类消毒剂和/或季铵盐类消毒剂与水溶性阴离子型纤维素及其衍生物。本发明的治疗开放性损伤的复合物在各种应急情况下，能够将伤口暴露的时间减到最少，最大程度地减少细菌、细菌内毒素的数量。本发明的治疗开放性损伤的复合物便于贮备、携带、使用，专注开放性损伤治疗领域，有着广阔的应用前景。
Description
技术领域
本发明属于医药技术领域，具体涉及一种治疗开放性损伤的复合物及其制备方法和应用，该治疗开放性损伤的复合物可用于治疗开放性损伤。
背景技术
开放性损伤，与闭合性损伤相反，顾名思义就是受伤部位的内部组织(如肌肉、骨头等)与外界相通的损伤；简言之就是血能往外流的，或肌肉或骨头外漏的创伤。如擦伤、撕裂伤、切伤、刺伤等。而闭合性损伤一般都是不见血的创伤，如肌肉拉伤等。开放性损伤不论平时或战时都较多见，因伤口多有污染，如处理不及时或不当，易发生感染，影响愈合和功能恢复，严重者可造成残废甚至危及伤员的生命。开放性损伤与闭合性损伤多用于创伤检查报告中。
一般严重外力所致的开放性损伤其病变可分为三区：第一区为表面或中心部直接接触区，可有异物存留和组织坏死。第二区为周围区域，各层组织损伤可引起坏死，如不切除，易引起感染。第三区为外周组织震荡反应，有水肿、渗出、血管痉挛、细胞活力低，如不发生感染，可以恢复正常，如发生感染，则使反应加重。由火器伤所致的伤道由内而外也可分为三区，原发伤道区系直接损伤，有失活组织、异物、血块及渗出。紧靠伤道外周为挫伤区，组织可发生部分或全部坏死。再外为震荡区，可有血循环障碍、水肿、渗出、阏血等改变。
开放性损伤的处理，目的在于改善修复条件，促使及早愈合。根据伤情，分别处理清洁、污染、感染伤口以及战伤。
伤口感染的主要因素：伤口暴露时间、伤口部位细菌数量、伤口部位细菌毒素数量。第一时间对开放性损伤进行消毒治疗是防止伤口感染的关键。
伤口局部消毒剂选择标准：广泛的杀菌力、局部使用不易被机体吸收、对伤口及机体不发生过敏反应、局部使用浓度安全。
目前世界范围常用的化学消毒剂主要有:①醛类：包括甲醛、戊二醛；②烷基化气体类：环氧乙烷；③卤素类：碘、氯；④醇类：乙醇；⑤酚类：来苏尔；⑥胍类：氯已定、聚六亚甲基胍；⑦季铵盐类：苯扎溴铵、苯扎氯铵、度米芬；⑧过氧化物类：过氧乙酸。其中，醛类、酚类、醇类、过氧化物类刺激性较强不适合用于开放性损伤，烷基化气体类常温为气态不易使用，也不适合用于开放性损伤，卤素类稳定性差，不适合制成产品长期使用；胍类、季铵盐类消毒剂，符合伤口使用的基本要求，适宜制成医疗产品。
目前的用于开放性损伤的消毒产品主要有：
第一种，含有具有消毒剂的医用凝胶产品。此类产品含有大量水，不能够对开放性伤口渗出的血液、体液、脓液进行吸收，导致配方中的消毒剂不能与伤口充分接触，容易被渗出液稀释，不能保持在伤口部位的有效杀菌浓度。配方中还含有各种糖类、氨基酸类、电解质类物质，为微生物提供了营养物质，不利于维持伤口的无菌环境。
如专利CN105055304A公开了一种含复合杀菌成份的免洗护肤消毒凝胶。其技术方案为，提前2天将保湿剂浸入去离子水中，使其溶解后备用；提前1天将增稠剂搅拌溶于水中备用；常温下取抗抑菌剂溶于乙醇中，加入季铵盐类消毒剂、双胍类消毒剂，再加已完全溶解的增稠剂溶液及溶解好的保湿剂溶液，搅拌均匀后，用中和剂调PH值至5.0-7.5，再补加去离子水至全量，搅匀后凝固得本发明免洗护肤消毒凝胶。该申请中，此类产品含有大量水，不能够对开放性损伤渗出的血液、体液、脓液进行吸收，导致配方中的消毒剂不能与伤口充分接触，容易被渗出液稀释，不能保持在伤口部位的有效杀菌浓度。
如专利103493852A公开了一种中药消毒凝胶，其100重量份的消毒液中含有下列重量份成分混合而成：60-70份复合中药材的提取物，三氯羟基二苯醚0.3--0.35，羟丙基甲基纤维素2-5，甘油1-3，乙醇60-70、水余量；所述的复合中药材的原料药重量比为：亳菊花20-25、桔梗10-15、千里光10-15、蒲公英10-15、五倍子5-10、龙胆草15-20、苍耳子10-15、松针15-20、白芷10-15、黄芩7-12、土茯苓15-20、柴胡15-20、川芎7-12，徐长卿5-10、贯众5-10。该凝胶产品配方中含有大量的中药提取物，这些提取物中含有各种糖类、氨基酸类、电解质类物质，为微生物提供了营养物质，不利于维持伤口的无菌环境。
第二种，使用消毒剂与成膜剂混合。使用在伤口部位，可快速成膜封闭创面。同样，不能够对开放性损伤渗出的血液、体液、脓液进行吸收。配方中成膜剂的快干特性，将会把大量消毒剂封闭在膜剂内部，无法产生预期的作用。只有产品表层的消毒剂能与伤口充分接触，容易被渗出液稀释，不能保持在伤口部位的有效杀菌浓度。
第三种，消毒剂与各种中药成分混合，浸于止血纱布。由于消毒剂与其它成分只是物理混合，会发生在止血的初期，消毒剂浓度梯度最大，释放速度过快，消毒剂大量释放后，后期又会有浓度下降的现象。因此有导致伤口部位过量吸收中毒或有效浓度偏低的风险。配方中的中药成分复杂，含有糖类、蛋白类、脂类等多种营养成分，为微生物提供了营养物质，不利于维持伤口的无菌环境。如专利104524621A公开的一种藕粉止血纱布，由下述重量份的原料制得：藕粉6-8，木薯淀粉2-4，明胶6-8，丙二醇1-2，海藻酸钠2-4，羧甲基纤维素钠2-4，酒石酸0.5-1，紫苏油1-2，肉豆蔻酸异丙酯0.3-0.5，聚山梨酯-800.1-0.2，对羟基苯甲酸甲酯0.01-0.03，辅料1-2，水200-250。
发明内容
为了解决上述问题，本发明提供了一种治疗开放性损伤的复合物。
本发明的另一目的在于提供了该治疗开放性损伤的复合物的制备方法。
本发明的另一目的在于提供了该治疗开放性损伤的复合物的用途。
本发明是通过下述的技术方案来实现的：
一种治疗开放性损伤的复合物，由如下原料制成：胍类消毒剂和/或季铵盐类消毒剂与水溶性阴离子型纤维素及其衍生物。
上述的治疗开放性损伤的复合物中，所述胍类消毒剂为氯已定或其药学上可接受的盐、聚六亚甲基胍或其药学上可接受的盐中的一种或几种；所述铵盐类消毒剂为苯扎氯铵、苯扎溴铵、度米芬中的一种或几种；所述水溶性阴离子型纤维素衍生物为羧甲基纤维素钠或羧甲基纤维素部分交联物中的一种或两种。
优选的，上述的治疗开放性损伤的复合物中，所述氯已定药学上可接受的盐为盐酸氯已定、醋酸氯已定或葡萄糖酸氯已定；所述聚六亚甲基胍药学上可接受的盐为盐酸聚六亚甲基胍、硫酸聚六亚甲基胍或硬脂酸聚六亚甲基胍。
所述氯已定或其药学上可接受的盐/羧甲基纤维素钠复合物中氯已定含量以氯已定计为每g复合物中含氯已定10mg-80mg。
所述聚六亚甲基胍或其药学上可接受的盐/羧甲基纤维素钠复合物中聚六亚甲基胍含量以聚六亚甲基胍计每g复合物中含聚六亚甲基胍7mg-30mg。
所述苯扎氯铵羧甲基纤维素钠复合物中苯扎氯铵含量为每g复合物中含苯扎氯铵4mg-20mg。
所述苯扎溴铵羧甲基纤维素钠复合物中苯扎溴铵含量为每g复合物中含苯扎溴铵4mg-20mg。
所述度米芬羧甲基纤维素钠复合物中度米芬含量为每g复合物中含度米芬10mg-50mg。
上述的治疗开放性损伤的复合物的制备方法，包括如下步骤：常温下，向浓度为65％-90％的乙醇溶液加入胍类消毒剂和/或季铵盐类消毒剂，使其完全溶解，再加入水溶性阴离子型纤维素或其衍生物，搅拌或超声振荡使其充分反应，取出复合物湿品，干燥，即得。
上述的治疗开放性损伤的复合物在制备治疗开放性损伤的医疗用品中的应用，所述医疗用品可以为药品或医疗器械。
本发明的有益效果在于，
本发明治疗开放性损伤的复合物，对消毒剂进行了筛选，最终选择了具有广泛的杀菌力、局部使用不易被机体吸收、对伤口及机体不发生过敏反应、局部使用浓度安全的胍类、季铵盐类消毒剂，使得本发明的消毒剂具有广泛的杀菌力、局部使用不易被机体吸收、对伤口及机体不发生过敏反应、局部使用浓度安全。
本发明的治疗开放性损伤的复合物中，胍类、季铵盐类消毒剂与水溶性阴离子型纤维素衍生物，在一定的工艺条件下，制成复合消毒止血材料。胍类、季铵盐类消毒剂的离子状态均表达电正性。水溶性阴离子型纤维素及其衍生物的离子状态均表达电负性。在能够提供适宜离子环境溶媒体系中，胍类、季铵盐类消毒剂与水溶性阴离子型纤维素衍生物，反应生成以弱离子键结合的复合物。再通过清洗除盐净化产品，真空干燥去除溶媒得到理化性质稳定的复合物，然后进行灭菌，得到最终产品。
本发明的治疗开放性损伤的复合物在开放性损伤治疗中有优良、特有的性能。本发明的治疗开放性损伤的复合物是通过真空干燥、灭菌得到的无菌产品，具备超长的质量保证特点，不会对伤口产生二次污染。更重要的是，经过真空干燥的复合物中水溶性阴离子型纤维素衍生物基团，能够快速吸收伤口部位的血液、体液、脓液等。同时发生溶胀、溶解。在伤口各种渗出液形成的离子环境下，复合物间的弱离子键打开，释放出电正性的消毒剂。这一进程与伤口产生的各种渗出液体的数量，成正相关关系，在治疗过程中，本发明的治疗开放性损伤的复合物能够实现到对消毒剂控释的功能。治疗过程中，本发明的治疗开放性损伤的复合物不会因出血等液体量增加，大幅降低伤口部位消毒剂的有效浓度；也不会在治疗的初期大量释放消毒剂，超过伤口部位允许使用的消毒剂安全浓度，不会发生伤口局部及全身过敏、中毒等不良反应。
本发明的治疗开放性损伤的复合物制备使用的全部原料，胍类、季铵盐类消毒剂和水溶性阴离子型纤维素衍生物，均能够符合国家标准或中国药典标准，具有可靠的质量控制标准及分析方法，可以确保原料质量合格，最终降低本发明的治疗开放性损伤的复合物在实施中的风险。
本发明的治疗开放性损伤的复合物在伤口愈合良好的情况下，其余部分可用纯化水或生理盐水等，进行溶解移除。不会对已愈合的伤口产生不良影响，不会因除去治疗材料，造成伤口的二次伤害。
本发明的治疗开放性损伤的复合物可制成无菌产品，配方所用成分简单，物理化学性质稳定，水分含量很低，有利于产品的长期保存。本发明的治疗开放性损伤的复合物体积小、单位重量很轻(1克产品能够对常规开放性损伤完全包覆治疗)。本发明的治疗开放性损伤的复合物在各种应急情况下，能够将伤口暴露的时间减到最少，最大程度的减少细菌、细菌内毒素的数量。本发明的治疗开放性损伤的复合物便于贮备、携带、使用，专注开放性损伤治疗领域，功能及适用性均优于同类产品，有着广阔的应用前景。
具体实施方式
下面结合具体实施例对本发明作更进一步的说明，以便本领域的技术人员更了解本发明，但并不因此限制本发明。
实施例1
95％药用乙醇，加入适量的纯化水，配制成浓度为65％-90％的乙醇溶液。常温下加入氯已定，搅拌至氯已定完全溶解，制成浓度0.1％-0.5％的氯已定乙醇溶液。取上述溶液300升，加入反应釜。称取羧甲基纤维素钠8-15kg，在常温、搅拌或超声振荡下，缓慢加入反应釜，确保30-60分钟完全加完。由于反应为非均相体系，需进行充分搅拌或超声振荡，确保反应进行完全。本反应为放热反应，反应过程不需要进行加热。继续反应2-3小时后，分三次加入各100升浓度为65％-90％的乙醇溶液，进行清洗。然后，从反应釜中取出复合物湿品。放入真空干燥箱，不超过50℃，真空干燥。控制终点水分不超过5％。产品包装后进行灭菌，测定成品氯已定含量10mg-80mg/g。
实施例2
95％药用乙醇，加入适量的纯化水，配制成浓度为65％-90％的乙醇溶液。常温下加入20％聚六亚甲基胍，搅拌至聚六亚甲基胍完全溶解，制成浓度0.1％-0.5％的聚六亚甲基胍乙醇溶液。取上述溶液300升，加入反应釜。称取羧甲基纤维素钠10-16kg，在常温、搅拌或超声振荡下，缓慢加入反应釜，确保30-60分钟完全加完。由于反应为非均相体系，需进行充分搅拌或超声振荡，确保反应进行完全。本反应为放热反应，反应过程不需要进行加热。继续反应2-3小时后，分三次加入各100升浓度为65％-90％的乙醇溶液，进行清洗。然后，从反应釜中取出复合物湿品。放入真空干燥箱，不超过50℃，真空干燥。控制终点水分不超过5％。产品包装后进行灭菌，测定成品聚六亚甲基胍含量7mg-30mg/g。
实施例3
95％药用乙醇，加入适量的纯化水，配制成浓度为65％-90％的乙醇溶液。常温下加入苯扎溴铵，搅拌至苯扎溴铵完全溶解，制成浓度0.1％-0.5％的苯扎溴铵乙醇溶液。取上述溶液300升，加入反应釜。称取羧甲基纤维素钠12-20kg，在常温、搅拌或超声振荡下，缓慢加入反应釜，确保30-60分钟完全加完。由于反应为非均相体系，需进行充分搅拌或超声振荡，确保反应进行完全。本反应为放热反应，反应过程不需要进行加热。继续反应1-2小时后，分三次加入各100升浓度为65％-90％的乙醇溶液，进行清洗。然后，从反应釜中取出复合物湿品。放入真空干燥箱，不超过50℃，真空干燥。控制终点水分不超过5％。产品包装后进行灭菌，测定成品苯扎溴铵含量4mg-20mg/g。
实施例4
95％药用乙醇，加入适量的纯化水，配制成浓度为65％-90％的乙醇溶液。常温下加入苯扎氯铵，搅拌至苯扎氯铵完全溶解，制成浓度0.1％-0.5％的苯扎氯铵乙醇溶液。取上述溶液300升，加入反应釜。称取羧甲基纤维素钠12-20kg，在常温、搅拌或超声振荡下，缓慢加入反应釜，确保30-60分钟完全加完。由于反应为非均相体系，需进行充分搅拌或超声振荡，确保反应进行完全。本反应为放热反应，反应过程不需要进行加热。继续反应1-2小时后，分三次加入各100升浓度为65％-90％的乙醇溶液，进行清洗。然后，从反应釜中取出复合物湿品。放入真空干燥箱，不超过50℃，真空干燥。控制终点水分不超过5％。产品包装后进行灭菌，测定成品苯扎氯铵含量4mg-20mg/g。
实施例5
95％药用乙醇，加入适量的纯化水，配制成浓度为65％-90％的乙醇溶液。常温下加入度米芬，搅拌至度米芬完全溶解，制成浓度0.1％-0.5％的度米芬乙醇溶液。取上述溶液300升，加入反应釜。称取羧甲基纤维素钠8-15kg，在常温、搅拌或超声振荡下，缓慢加入反应釜，确保30-60分钟完全加完。由于反应为非均相体系，需进行充分搅拌或超声振荡，确保反应进行完全。本反应为放热反应，反应过程不需要进行加热。继续反应1-2小时后，分三次加入各100升浓度为65％-90％的乙醇溶液，进行清洗。然后，从反应釜中取出复合物湿品。放入真空干燥箱，不超过50℃，真空干燥。控制终点水分不超过5％。产品包装后进行灭菌，测定成品度米芬含量10mg-50mg/g。
对本发明的治疗开放性损伤的复合物进行了抑菌实验，详情如下：
1、实验材料：供试品治疗开放性损伤的复合物5g，未复合的羧甲基纤维素钠5g为对照。
2、实验菌种：金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念球菌、黑曲霉培养基：胰酪大豆琼脂培养基、沙氏葡萄糖琼脂培养基
3、实验方法：
菌液制备：金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念球菌用0.9％无菌氯化钠溶液制成1ml约含有108cfu菌悬液，黑曲霉用含0.05％聚山梨酯80的0.9％无菌氯化钠溶液制成含108cfu孢子悬液。
取200ml无菌试管10个，分别加入供试品和对照品1g/管，加入100ml的0.9％无菌氯化钠溶液溶解供试品。每管分别单独接种以上菌液，接种菌液量为106cfu/管,充分混合，20-25℃避光贮存。根据规定时间，进行存活菌数测定，再根据接入菌数计算减少的log值。
实验结果：
实验结论：治疗开放性损伤的复合物具有极好的杀菌消毒的作用。对革兰阳性菌、革兰阴性菌、细菌芽胞、真菌、孢子均表现出杀灭能力，并可长期保持消毒后的无菌效果。未复合的羧甲基纤维素钠，没有杀菌作用，但对各种菌的生长也具有一定的抑制作用。本实验是在供试品进行100倍稀释后进行的，因此本专利在实际应用过程中，遇血液等液体稀释后，仍能保持原始设计功能。
Claims (10)
1.一种治疗开放性损伤的复合物，由如下原料制成：胍类消毒剂和/或季铵盐类消毒剂与水溶性阴离子型纤维素及其衍生物。
2.根据权利要求1所述的治疗开放性损伤的复合物，其特征在于，所述胍类消毒剂为氯已定或其药学上可接受的盐、聚六亚甲基胍或其药学上可接受的盐中的一种或几种；所述季铵盐类消毒剂为苯扎氯铵、苯扎溴铵、度米芬中的一种或几种；所述水溶性阴离子型纤维素衍生物为羧甲基纤维素钠或羧甲基纤维素部分交联物中的一种或两种。
3.根据权利要求2所述的治疗开放性损伤的复合物，其特征在于，所述氯已定药学上可接受的盐为盐酸氯已定、醋酸氯已定或葡萄糖酸氯已定；所述聚六亚甲基胍药学上可接受的盐为盐酸聚六亚甲基胍、硫酸聚六亚甲基胍或硬脂酸聚六亚甲基胍。
4.根据权利要求2所述的治疗开放性损伤的复合物，其特征在于，所述氯已定或其药学上可接受的盐/羧甲基纤维素钠复合物中氯已定含量以氯已定计为每g复合物中含氯已定10mg-80mg。
5.根据权利要求2所述的治疗开放性损伤的复合物，其特征在于，所述聚六亚甲基胍或其药学上可接受的盐/羧甲基纤维素钠复合物中聚六亚甲基胍含量以聚六亚甲基胍计每g复合物中含聚六亚甲基胍7mg-30mg。
6.根据权利要求2所述的治疗开放性损伤的复合物，其特征在于，所述苯扎氯铵羧甲基纤维素钠复合物中苯扎氯铵含量为每g复合物中含苯扎氯铵4mg-20mg。
7.根据权利要求2所述的治疗开放性损伤的复合物，其特征在于，所述苯扎溴铵羧甲基纤维素钠复合物中苯扎溴铵含量为每g复合物中含苯扎溴铵4mg-20mg。
8.根据权利要求2所述的治疗开放性损伤的复合物，其特征在于，所述度米芬羧甲基纤维素钠复合物中度米芬含量为每g复合物中含度米芬10mg-50mg。
9.权利要求1所述的治疗开放性损伤的复合物的制备方法，包括如下步骤：常温下，向浓度为65％-90％的乙醇溶液加入胍类消毒剂和/或季铵盐类消毒剂，使其完全溶解，再加入水溶性阴离子型纤维素或其衍生物，搅拌或超声振荡使其充分反应，取出复合物湿品，干燥，即得。
10.权利要求1所述的治疗开放性损伤的复合物在制备治疗开放性损伤的医疗用品中的应用。
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