CN106166209B - 用于促进i期、ii期压疮愈合、预防压疮iii期的消炎粉 - Google Patents
用于促进i期、ii期压疮愈合、预防压疮iii期的消炎粉 Download PDFInfo
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Abstract
本发明提供了一种用于促进Ⅰ期、Ⅱ期压疮愈合、预防压疮Ⅲ期的消炎粉,其原料药包括甲硝唑粉、珍珠粉、烟灰、地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、乌贼骨、蜂房、龙血竭、白头翁、生黄芪、透骨草。本发明中药制剂具有活血化瘀、收湿敛疮的功效,采用中西医结合的治疗方法,使西药甲硝唑粉与中药复方成分配合使用,通过外用药物,作用于压疮部位,使药物吸收迅速,对于压疮的愈合具有良好的治疗作用,在完成相关安全性检测及临床研究后,适用于临床推广应用。
Description
技术领域
本发明涉及中医药技术领域,尤其涉及一种用于促进I期、II期压疮愈合、预防压疮III期的消炎粉。
背景技术
压疮(PU)是由于皮肤和皮下组织通过长期受压,血液循环不良,致使受压部分组织缺血而腐败乃至坏死,在昏迷、尿失禁、营养不良、长期卧床等不能自主翻身的危重患者比较多见。特别是骨的突起,如:肩胛骨、坐骨结节、骶尾部、脚跟或枕为好发部分。压疮是长时间卧床患者较为习见的并发症之一。压疮的产生不但会损耗巨额的医药护理费用,加大患者的疼痛和经济负担,而且会使患者的生活质量下降,影响疾病的痊愈,还可能使病情加重乃至危及生命。
随着不断深入对医学的研究,对于压疮,国内外也开展了大批的研究,但从全世界范围来看,与15年前相比压疮发生率并没有显著下降,于今依然是护理学领域的一大难题。研究表明,目前约有20%需要长期护理的患者受到压疮的困扰。经调查,德国压疮患病率平均为4.7%;约旦的压疮患病率平均为12%,其中压疮最常见部位为骶尾部和足跟部;Abel等调查美国的12家养老院得出结论,美国养老院平均压疮患病率为13.6%;在威尔士,James等调查威尔士的社区医院的压疮发生率,分析压疮患病率平均为26.7%。还有调查表明,在美国高达10亿美元的年费用用在治疗压疮上。英国每年经费为1.8亿-7.5亿英镑用在预防,对压疮的治疗保健经费约1.8亿-3.2亿英镑。
因此,压疮一直是医疗护理领域的焦点。至今为止,尽管国内外对于压疮的防患和医疗方面的研究不少,治疗压疮的方式也很多,有化学方法、物理方法、中西医结合方法等。但临床上仍没有快速治疗压疮的特效药。压疮仍然是医疗、护理领域的顽疾。目前通过肉眼观察到的组织改变为主要的压疮诊断方法,治疗也只是对症治疗,局限于治疗经验,没有权威性的指导,缺乏有效的科学依据。因此,通过对压疮组织变化进行研究,透彻的认识压力性溃疡的形成及进展机制并探讨早期诊断和治疗措施是当前急待解决的医学问题。
缺血再灌注损伤(I/RI)是指机体许多缺血组织或器官再重新再灌注血液后,不仅不能使组织、器官功能恢复,反而使组织或器官的结构损伤和功能障碍加重的现象,是外科常见的组织器官损伤,尤其在一些疾病的病理演变过程中起重要作用,比如严重感染、休克、创伤、心肺功能不全等。近年来,随着多器官I/RI研究的不断深入,I/RI被认为是压疮形成过程中最重要的致病因素之一,这已得到众多学者的广泛认同。I/RI是一个非常复杂的过程,涉及到缺乏能量、过度活化白细胞、过度释放氧自由基及激活炎性细胞因子,另外钙超载、细胞凋亡、血管内皮细胞功能障碍等也是其因素,且各因素之间互为因果。但究竟是什么因素起着核心作用,值得进一步研究。
炎性因子和氧自由基在压疮I/RI的作用已得到了人们的共识。氧自由基增多导致的氧化应激损伤在再灌注后发生的I/RI中发挥了关键作用。组织I/R后,细胞膜脂质微环境发生紊乱,自由基大量产生及自由基引发的脂质过氧化作用增强,从而使细胞膜和细胞器膜的通透性增高,损伤细胞的结构和功能,造成各种细胞功能障碍。缺血再灌注继发的炎症级联反应促进二次组织损伤,在I/R损伤中起着重要的作用,也是致使组织损伤的重要途径之一。
中医认为压疮的发生多由患者因久病卧床,气血运行失畅,肌肤失养;或因摩擦皮肤、汗液、盐碱等毒邪浸淫而产生,中医对此病的认识由来已久,对于其治疗遵循辨证施治,按理法方药活血化瘀、去腐生肌、扶正脱毒、收湿敛疮的功效,本发明消炎粉采用中西医结合的治疗方法,使西药甲硝唑粉与中药复方成分配合使用,通过外用,作用于压疮部位,使药物吸收迅速,对于压疮的愈合具有良好的治疗作用,在完成相关安全性检测及临床研究后,适用于临床推广应用。
发明内容
本发明所要解决的技术问题是提供一种用于促进I期、II期压疮愈合、预防压疮III期的消炎粉,其具有活血化瘀、去腐生肌、扶正脱毒、收湿敛疮的功效,本发明消炎粉采用中西医结合的治疗方法,使西药甲硝唑粉与中药复方成分配合使用,通过外用药物,作用于压疮部位,使药物吸收迅速,对于压疮的愈合具有良好的治疗作用,在完成相关安全性检测及临床研究后,适用于临床推广应用。
基于此,本发明提供了一种用于促进I期、II期压疮愈合、预防压疮III期的消炎粉,其原料药包括甲硝唑粉、珍珠粉、烟灰、地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、蜂房、龙血竭、白头翁、生黄芪、透骨草。
其中,所述各成分的重量比为甲硝唑粉∶珍珠粉∶烟灰∶地肤子∶白鲜皮∶蛇床子∶滑石∶煅牡蛎∶蜂房∶龙血竭∶白头翁∶生黄芪∶透骨草=2∶1∶1∶1~1.25∶1~1.25∶1~1.25∶1~1.25∶1~1.25∶0.5~0.6∶0.5~0.6∶0.5~0.6∶1.25~1.5∶0.5~0.6。
其中,所述各成分的重量比为甲硝唑粉∶珍珠粉∶烟灰∶地肤子∶白鲜皮∶蛇床子∶滑石∶煅牡蛎∶蜂房∶龙血竭∶白头翁∶生黄芪∶透骨草=2∶1∶1∶1.25∶1.25∶1.25∶1.25∶1.25∶0.6∶0.6∶0.6∶1.5∶0.75。
本发明还提供了上述消炎粉的制备方法,其包括:
第一步,甲硝唑粉、珍珠粉、烟灰采用中药超微粉碎机分别粉碎成200目的粉末,备用;
第二步,采用醇提法提取地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、蜂房、龙血竭、白头翁、生黄芪和透骨草形成的混合物,醇提液浓缩除去乙醇,干燥后亦放入中药超微粉碎机中粉碎成200目粉末;
第三步,将前两步获得的粉末混合到一起,加入适量载体,获得消炎粉。
其中,所述第二步进一步具体为分别按重量称取地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、蜂房、龙血竭、白头翁、生黄芪和透骨草,混合在一起,加入相对于混合物质量3~4倍的醇浓度90%的乙醇,加热回流提取2小时,提取液过滤,滤渣再次加入相对于混合物质量2~3倍的醇浓度90%的乙醇,加热回流提取2小时,提取液合并,浓缩除去乙醇,干燥后放入中药超微粉碎机中粉碎成200目粉末。
其中,载体优选加入淀粉。
其中,淀粉的加入量是混合粉末质量的2倍至3倍。
有益的技术效果
本发明提供的消炎粉具有活血化瘀、去腐生肌、扶正脱毒、收湿敛疮的功效,采用中西医结合的治疗方法,使西药甲硝唑粉与中药复方成分配合使用,通过外用药物,作用于压疮部位,使药物吸收迅速,对于促进I期、II期压疮愈合、预防压疮III期具有良好的效果。
具体实施方式
本发明提供了一种用于促进I期、II期压疮愈合、预防压疮III期的消炎粉,其原料药包括甲硝唑粉、珍珠粉、烟灰、地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、蜂房、龙血竭、白头翁、生黄芪、透骨草。
本发明消炎粉临床应用于主要用于治疗I期(为压疮初期,局部皮肤受压,出现暂时血液循环障碍,表现为红肿、热、麻木或触痛。此期皮肤表面无破损情况,为可逆性改变)、II期(红肿部位继续受压,血液循环得不到改善,静脉回流受阻,受压部位因淤血而呈现***,有皮下硬节和(或)有水疱形成。水疱破溃后,可见潮湿红润的创面,病人有疼痛感。)压疮愈合,或预防压疮III期(静脉血回流严重受阻,局部淤血导致血栓形成,组织缺血、缺氧。轻者表皮水疱破溃后出现真皮层组织感染,浅层组织坏死,溃疡形成;重者坏死组织发黑,脓性分泌物增多,有臭味,可向深部扩散,甚至到达骨骼,更严重者还可出现脓毒败血症)的发生及发展,采用了中西药结合的方式,进行组方用药,本发明消炎粉以甲硝唑、珍珠粉、烟灰为主药药物组合,其用量比通过实验研究发现在2∶1∶1的比例下,具有最好的治疗压疮、预防感染的功效,通过与其他药物的配合使用,增强其疗效,发挥了中西医治疗压疮的优势。本发明消炎粉中,针对创面出现的皮疹、溃烂等情况,在相对缺氧的情况下滋生大量厌氧菌细菌,甲硝唑可以用于治疗或预防厌氧菌引起的***或局部感染,对于压疮部位长期血供较差,出现气虚血瘀、毒邪侵袭等情况,使用珍珠粉,具有清热解毒,收敛生肌之功效,现代医学研究,珍珠水解液可抑制小鼠自主活动,并有抑制脂褐素和清除氧自由基作用,珍珠膏有促进创面愈合作用,因此有很好的治疗作用,本发明消炎粉的主要药物之一烟灰是烟叶燃烧后的产物,烟叶来源于茄科烟草属植物烟草的全草,经过燃烧后,将有毒成分燃烧或挥发掉,经过高温燃烧,又起到了消毒杀菌作用,使灰分干净无菌,烟灰自古以来就是医家常用药物,具有消肿解毒,祛风止痒,杀虫,收敛止血的功效,常用于疔疮肿毒,头癣,白癣,秃疮,毒蛇咬伤,蚊虫叮咬,对于压疮的血瘀湿阻的病因病机具有很好的对证治疗作用,烟叶燃烧形成烟叶灰相当于中药炮制中的烟叶炒炭,即“存性”,能缓和药物的烈性或副作用,增强收敛固涩功效,增强其收敛止血的作用,能有效杀死皮肤表层上的真菌,使皮肤表面保持干燥,对皮肤表面的 擦伤也有很好的治疗作用。由此可见,本发明消炎粉三味主要相互配合,各司其职,共同起到清热解毒、收湿敛疮、止血止痒的功效,治疗厌氧菌、真菌等作用,对于压疮的愈合及感染的预防具有很好的作用。
中药的使用讲究的是配伍用药,我们研究发现,临床中单纯使用甲硝唑其对于厌氧菌感染有较好的治疗作用,但是对于局部血液循环的改善、皮肤创面的愈合、局部疼痛的缓解无显著作用、单纯使用中药珍珠粉、烟灰对于局部疼痛缓解、创面收敛愈合有很好的作用,同时对于真菌感染有较显著的作用,然而对于厌氧菌的感染、对于局部血液循环的改善无显著作用。通过研究发现,将三种药物混合一起使用时,对于压疮各期的主要病因病机均由较为明显的作用,但对于皮肤瘙痒、湿疹的治疗等效果尚达不到满意疗效,因此,在主药(君药)的作用下,加入地肤子、白鲜皮、蛇床子祛风除湿、杀虫疗癣,三药在临床使用过程中,对于湿疹有很好的治疗作用,加入滑石、煅牡蛎清热燥湿、收湿敛疮,配合君药烟灰,增强其敛湿之功效,对于湿疹初起或后期久不收口有很好的改善作用,同时现代医学研究,其有效成分对于真菌具有很好的抑制作用,加入蜂房、生黄芪补虚固本,脱毒生肌,患者旧病卧床,旧卧伤气,其气必虚,故加入两药补气顾元,加入白头翁清热解毒、凉血止血,对于压疮创面破溃出血具有很好的治疗作用,加入龙血竭活血散瘀,定痛止血,敛疮生肌的功效,有效预防压疮从II期向III期发展,诸药合用,共为臣药组。本发明消炎粉使用透骨草,其味辛甘,性温,具有很好的祛风除湿、舒筋活络、活血止痛、解毒透疹的功效,自古以来对于外科用药,多用透骨草来引药从皮肤入里起效,配白鲜皮,白鲜皮苦能燥湿,泻火解毒,两药合用,治疗湿疹热疮。燥皮肤之湿,解肌蕴之毒,其效显著,现代医学研究发现,其中透骨草素具有很好的促进药物透皮吸收的作用,在本发明中药制剂中,作为佐使药使用。全方合用,共奏活血化瘀、去腐生肌、扶正脱毒、收湿敛疮的功效,通过外用药物,作用于压疮部位,使药物吸收迅速,对于压疮的愈合具有良好的治疗作用,在完成相关安全性检测及临床研究后,适用于临床推广应用。
进一步优选,所述消炎粉仅由上述原料制备而成。
所述各成分的重量比为甲硝唑粉∶珍珠粉∶烟灰∶地肤子∶白鲜皮∶蛇床子∶滑石∶煅牡蛎∶蜂房∶龙血竭∶白头翁∶生黄芪∶透骨草=2∶1∶1∶ 1~1.25∶1~1.25∶1~1.25∶1~1.25∶1~1.25∶0.5~0.6∶0.5~0.6∶0.5~0.6∶1.25~1.5∶0.5~0.6。
进一步优选,所述各成分的重量比为甲硝唑粉∶珍珠粉∶烟灰∶地肤子∶白鲜皮∶蛇床子∶滑石∶煅牡蛎∶蜂房∶龙血竭∶白头翁∶生黄芪∶透骨草=2∶1∶1∶1.25∶1.25∶1.25∶1.25∶1.25∶0.6∶0.6∶0.6∶1.5∶0.75。
本发明还提供了上述消炎粉的制备方法,其包括:
第一步,甲硝唑粉、珍珠粉、烟灰采用中药超微粉碎机分别粉碎成200目的粉末,备用;
第二步,采用醇提法提取地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、蜂房、龙血竭、白头翁、生黄芪和透骨草形成的混合物,醇提液浓缩除去乙醇,干燥后亦放入中药超微粉碎机中粉碎成200目粉末;
第三步,将前两步获得的粉末混合到一起,加入适量载体,获得消炎粉。
所述第二步进一步具体为分别按重量称取地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、蜂房、龙血竭、白头翁、生黄芪和透骨草,混合在一起,加入相对于混合物质量3~4倍的醇浓度90%的乙醇,加热回流提取2小时,提取液过滤,滤渣再次加入相对于混合物质量2~3倍的醇浓度90%的乙醇,加热回流提取2小时,提取液合并,浓缩除去乙醇,干燥后放入中药超微粉碎机中粉碎成200目粉末。
因为压疮创面初期多红肿热痛,中期多有泡疹或者破溃,若使用液体消毒液尽管有较好的浸润作用,然而过多的液体会导致创面感染更加严重,甚至加重皮损及浅组织坏死,因此采用粉剂,加入适量载体,不仅可以减少单位面积用药量,使用药温和,同时粉剂具有较好的吸湿作用,可以大大降低创面因潮湿导致的感染风险,通过多组实验验证,载体优选加入淀粉,淀粉的加入量是混合粉末质量的2倍至3倍,优选2倍。
各原料药药理如下:
珍珠粉:味成甘寒无毒。镇心点目。涂面,令人润泽好颜色。涂手足,去皮肤逆胪。除小儿惊热,安魂魄。解痘疗毒。
烟灰:辛,温。有毒,消肿解毒,祛风止痒,杀虫,收敛止血。用于疔疮肿毒,头癣,白癣,秃疮,毒蛇咬伤,蚊虫叮咬。烟灰选使用干净的香烟烟灰。
地肤子:拉丁名Kochiae Fructus,性寒,味辛、苦,具有清热利湿,祛风止痒的功效,主治小便涩痛、阴痒带下、风疹、湿疹、皮肤瘙痒等证。
白鲜皮:拉丁名Dictamni Cortex,味苦,成,性寒,归脾经;肺经;小肠经;胃经;膀胱经,具有清热燥湿;祛风止痒;解毒的功效,主治风热湿毒所致的风疹;湿疹;疥癣;黄疸;湿热痹痛等证。
蛇床子:拉丁名Cnidii Fructus,味辛、苦,性温,入肾经,具有温肾壮阳、燥湿杀虫、祛风止痒的作用,用于肾阳虚衰引起的男子阳痿、女子宫冷***,寒湿带下或腰膝冷痛等证。
滑石:味甘、淡,性寒,归膀胱、肺、胃经,具有利尿通淋,清热解暑,祛湿敛疮的功效。用于热淋,石淋,尿热涩痛,暑湿烦渴,湿热水泻;外治湿疹,湿疮,痱子等证。
煅牡蛎:味甘平,入心、肝经、肾经、大肠经,煅牡蛎具有镇惊安神,敛汗固精,止血涩肠,生肌敛疮的作用。用治惊痫癫狂,怔忡健忘,失眠多梦,自汗盗汗,遗精淋浊,吐衄便血,崩漏带下,泻痢脱肛,溃疡久不收口等证。
蜂房:味甘,性平,入胃经,具有祛风止痛,攻毒消肿,杀虫止痒的作用,用于风湿顽痹,风虫牙痛,痈疽疮毒,咽喉肿痛,风疹瘙痒,阳痿,遗尿等证。
龙血竭:味甘、辛、成、性温,归肺、脾、肾经,具有活血散瘀,定痛止血,敛疮生肌的功效。用于跌打损伤,瘀血作痛,妇女气血凝滞,外伤出血,脓疮久不收口等证。
白头翁:味苦、性寒,入胃、大肠经,具有清热解毒,凉血止痢的作用,主要用于胃肠有湿热积滞之发热腹痛、下痢脓血,里急后重等证;对大肠血热之热痢下血效果更好,对痢疾杆菌、伤寒杆菌、枯草杆菌、大肠杆菌、黄金色葡萄球菌、沙氏门菌有较强的抑制作用。
生黄芪:拉丁名astragali radix,味甘,性温,归脾、肺经,具有补益脾土,升举阳气、固表止汗,托疮生肌等功效,主治脾肺气虚所致之乏力食少便溏,心悸气短,中气下陷之脏器下垂,气不摄血之崩漏便血,久泻脱肛;表虚不固之自汗盗汗,气血不足等证。
透骨草:拉丁名Phryma leptostachya L.subsp.asiatica(Hara)Kitamura, 味甘、辛,性温,入肺、肝二经,具有祛风胜湿、活血止痛的功效,用于风湿关节痛;外用治疮疡肿毒。
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施。
实施例消炎粉1
甲硝唑粉200g、珍珠粉100g、干净的香烟烟灰100g采用中药超微粉碎机分别粉碎成200目的粉末,备用;称取地肤子125g、白鲜皮125g、蛇床子125g、滑石125g、煅牡蛎125g、蜂房60g、龙血竭60g、白头翁60g、生黄芪150g和透骨草75g,混合在一起,加入相对于混合物质量4倍的醇浓度90%的乙醇,加热回流提取2小时,提取液过滤,滤渣再次加入相对于混合物质量3倍的醇浓度90%的乙醇,加热回流提取2小时,提取液合并,浓缩除去乙醇,干燥后放入中药超微粉碎机中粉碎成200目粉末,将前两面获得的粉末混合到一起,每取500g混合粉末,加入500g载体淀粉,获得消炎粉1。
比较例1消炎粉2
珍珠粉200g、干净的香烟烟灰200g采用中药超微粉碎机分别粉碎成200目的粉末,备用;称取地肤子125g、白鲜皮125g、蛇床子125g、滑石125g、煅牡蛎125g、蜂房60g、龙血竭60g、白头翁60g、生黄芪150g和透骨草75g,混合在一起,加入相对于混合物质量4倍的醇浓度90%的乙醇,加热回流提取2小时,提取液过滤,滤渣再次加入相对于混合物质量3倍的醇浓度90%的乙醇,加热回流提取2小时,提取液合并,浓缩除去乙醇,干燥后放入中药超微粉碎机中粉碎成200目粉末,将前两面获得的粉末混合到一起,每取500g混合粉末,加入500g载体淀粉,获得消炎粉2。
比较例2消炎粉3
甲硝唑粉400g采用中药超微粉碎机分别粉碎成200目的粉末,备用;称取地肤子125g、白鲜皮125g、蛇床子125g、滑石125g、煅牡蛎125g、蜂房60g、龙血竭60g、白头翁60g、生黄芪150g和透骨草75g,混合在一起,加入相对于混合物质量4倍的醇浓度90%的乙醇,加热回流提取2小时,提取液过滤,滤渣再次加入相对于混合物质量3倍的醇浓度90%的乙醇,加热回流提取2小时,提取液合并,浓缩除去乙醇,干燥后放入中药超微粉碎机中 粉碎成200目粉末,将前两面获得的粉末混合到一起,每取500g混合粉末,加入500g载体淀粉,获得消炎粉3。
安全性验证
本发明消炎粉临床作用于I期、II期、III期压疮患者,结合床边护理及临床用药,一般治疗周期多为7~10天左右,较少连续用药超过14日,极少连续用药超过30日,因此,针对其主要应用方法,我们只设置大鼠急毒性试验即可,通过验证短期内大量外用本发明中药消炎粉对大鼠可能产生的毒理作用,来进一步验证本发明消炎粉临床使用的安全用量,为临床转化该药物提供实验数据。
消炎粉的制备方法同实施例1,区别在于混合粉末与载体淀粉的添加量比例为每91g混合粉末添加9g淀粉,形成消炎粉。
成年健康大鼠,20只,雌雄各半,实验前置动物于室内适应环境一周,自由摄食和摄水,室温18~22℃,相对湿度65~70%,照明昼夜明暗交替,给药前24h将动物背部脊柱两侧脱毛,去毛范围大约相当于体表面积的10%,在腿毛表面正中部位,用手术刀片横向划1cm切口,仅破损皮层,不到达肌肉及椎体,然后用无菌纱布止血。
因临床患者压疮部位多潮湿、溃烂,而大鼠毒性试验为保证消炎粉能够黏贴大鼠褪毛及破损部位,故将消炎粉放置于恒温恒湿箱内1小时,保持湿度为90%,温度为26℃,吸潮后,每1g药粉,含原药材0.91g(为了更好的探究其毒性,我们制备了纯药物组分消炎粉,降低了辅料淀粉的含量,如纯中西医组分消炎粉安全有效,那么加入相应辅料淀粉后,其载药量降低、释放速度减慢,临床使用是更加安全有效的)。此外,准备凡士林足量。
按照随机数字表,将大鼠分为对照组和实验组。实验组给药3次/d,每1em给药粉1g,即生药给药量为2.73g/cm2/d,给药量为正常剂量369.16倍(人与大鼠的给药换算为1∶6.01,正常人体给药,外用药为实施例1制备的消炎粉10g/d,按照药物与辅料1∶1计算,其中原药材含量为5g/d,2次/d,外用面积为225cm2),将药物均匀地涂敷于动物背部去毛区,并用无刺激性纱布、胶布加以固定。每日观察,连续10d。给药后要注意动物全身中毒表现和死亡情况,包括动物体重、皮肤、毛发、眼睛和粘膜的变化。呼吸、循环、中枢神经***、四肢活动等变化。若遇有死亡动物则需进行尸检和肉眼 观察,当有肉眼可见病变时,则需进行病理学检查。
结果与结论:通过急性毒理实验研究,观察10d大鼠涂药后情况,给药前,各组动物体重、进食、饮水情况无统计学差异,给药后,各组大鼠体重变化、进食饮水情况,无统计学差异。行为学无明显异常,未出现死亡及其他毒性反应。伤口愈合情况,给药组肉芽组织生长,无感染,其恢复程度显著优于对照组。
本实验组剂量,是临床成人用药的369.16倍,最大耐受量超过人临床日用剂量100倍以上,并且动物无死亡,该用药是安全的。
临床研究
一般资料
收集临床符合I期、II期压疮患者142例,其中男62例,女80例,随机分为两组,对照组70例,其中男31例,女39例,年龄46~72岁,平均59.51±16.14岁,住院时间平均18.15±6.31天,压疮面积平均8.48cm×9.40cm;治疗组72例,其中男31例,女41例,年龄47~74岁,平均59.10±15.04岁,住院时间平均17.55±7.10天,压疮面积平均8.16cm×8.99cm,住院病因不限定,对于中风、术后护理及用药均按各类手术指南进行。
治疗方法
一般治疗:每日进行翻身减压护理。
对照组:在一般治疗的基础上,创口常规护理,涂抹生肌玉红膏(主要成分为白芷、虫白蜡、当归、甘草、轻粉、血竭、紫草,北京同仁堂股份有限公司,国药准字Z11021000),1次/日,用药后用脱脂纱布覆盖。
治疗组:在一般治疗基础上,创口常规护理后,将消炎粉撒于压疮部位1次/日,用药后用脱脂纱布覆盖。
观察指标
创面愈合时间:从创面用药起到创面完全上皮化所需要的时间。
创面细菌感染情况:用无菌棉签拭取创面深部脓液分泌物,置于无菌标本盒中送微生物检验室,培养2d,确定细菌种类。
皮疹消退情况:肉眼观察患者压疮部位皮疹消退情况,记录消退时间。
疗效判定标准:参照国家中医药管理局《中医病证诊断疗效标准》。
治愈:褐色红斑消退,或溃烂疮口愈合。
好转:红斑未全消退,或溃烂疮面腐肉脱落,新肉生长,疮面逐渐缩小。
未愈:疮面增大,溃烂不止。
以治愈+好转计算总有效率。
实验数据均采用SPSS19.0统计分析软件包分析,实验数据以均数±标准差表示;组间计量资料比较采用单因素方差分析,以P<0.05为差异有统计学意义。
结果
两组患者感染率比较
表1两组患者感染率比较
与对照组比较,*P<0.05
两组患者创面愈合情况比较
表2两组患者创面愈合情况比较
组别 | N | 治愈 | 好转 | 未愈 | 有效率% |
对照组 | 70 | 13 | 43 | 14 | 80.00 |
治疗组 | 72 | 24 | 43 | 5 | 93.06<sup>*</sup> |
与对照组比较,*P<0.05
创面上皮化生时间
表3创面上皮化生时间
组别 | N | 创面上皮化生时间(d) |
对照组 | 70 | 13.1±6.6 |
治疗组 | 72 | 6.7±4.1<sup>*</sup> |
与对照组比较,*P<0.05
通过本发明中药消炎粉的临床观察,其效果显著优于临床药物生肌玉红膏,说明本发明中药消炎粉切实有效,适用于临床推广。
实验研究
健康SD大鼠,体质量(200±20)g,雄性,于室度25±2℃,正常昼夜节律环境中正常饲养1周,动物自由饮水,进食。
实验药品及耗材
实验药物:本发明实施例1制备的消炎粉1、本发明比较例1制备的消炎粉2、本发明比较例2制备的消炎粉3,因为大鼠活动不受人为控制,为了保证药物能够保留于大鼠压疮部位,因此将消炎粉加入一定量的蒸馏水,制备成含生药浓度为1g/ml的溶液,便于涂布。
阳性药物:重组人表皮生长因子外用溶液(深圳市华生元基因工程发展有限公司生产)。
超氧化物歧化酶(SOD)试剂盒和丙二醛(MDA)试剂盒,由南京建成生物有限公司提供。
白细胞介素-6(IL-6)放射免疫分析试剂盒,表皮生长因子(EGF)放射免疫分析试剂盒,均由美国KPL公司提供。
试验方法
取SD大鼠140只,雄性,常规饲养1周,随机分成7组,正常组(蒸馏水)、模型组(蒸馏水)、溶媒对照组(50%乙醇)、阳性药物组、实验组、比较1组、比较2组各20只。
除正常组外,将大鼠以20%乌拉坦每100g体质量0.5ml腹腔麻醉,大腿外侧局部去毛2cm×3cm,将大鼠固定在自制压疮器具下方的鼠板上,保持局部压8.86kPa(64mmHg),根据4个铁棒横截面的面积、压强和上压板的重量,算出所需加压沙袋的重量,按重量装沙袋,将其中1根铁棒压在大鼠去毛的大腿外侧,其余3根支在鼠板上,把沙袋放入上压板内,根据模具上的水平仪旋转调节铁棒,保持模具上压板与固定大鼠的板保持平行,保持局部受压皮肤潮湿,每次持续4h,加压结束后正常饲养,投食量减50%,自由饮水,连续1周,以局部皮肤外观和病理出现压疮病变为压疮模型复制成功。
给药方法
各组大鼠均采用局部给药,正常组和模型组涂抹0.2ml蒸馏水,溶媒对照组涂抹0.2ml的50%乙醇溶液,阳性药物组涂抹重组人表皮生长因子外用溶液(rhEGF)0.2ml,实验组、比较1组、比较2组分别涂布相应药物,每天涂抹0.2ml,分别含药量0.2g/ml,每天3次,分笼饲养,连续14d。第7天 和末次抹药后30min,各组大鼠取10只用20%乌拉坦按每100g体质量0.5ml腹腔注射麻醉,腹主动脉取血5ml,按放射免疫法试剂盒说明书操作,检测EGF、IL-6含量。取局部组织,观察皮肤病理变化。
统计学方法
实验数据均采用SPSS19.0统计分析软件包分析,实验数据以均数±标准差表示;组间计量资料比较采用单因素方差分析,以P<0.05为差异有统计学意义。
结果
①消炎粉对压疮模型大鼠局部组织病理变化的影响实验结果。
通过组织学观察,正常组为复层鳞状上皮,上皮组织结构清晰,肌纤维排列紧密有序。模型组和溶媒对照组上皮结构不清,肌纤维明显水肿,组织间充血严重。阳性药物组与实验组上皮组织结构逐渐清晰,肌纤维水肿逐渐减轻,组织间无充血。比较1组上皮组织结构逐渐清晰,肌纤维水肿减轻,组织无充血,较阳性药物组与消炎粉组比较,其皮损程度稍高,比较2组上皮结构较不清晰,肌纤维水肿有缓解,组织间充血,说明消炎粉能有效减轻局部损害,改善充血及皮损,与阳性药物作用相当,消炎粉去甲硝唑与两组比较差异不大,而消炎粉去珍珠母、烟灰对于改善充血及皮损的作用与两组比较有显著差异,但仍好于模型组及溶媒对照组。
消炎粉对压疮模型大鼠血清SOD含量的影响结果见表4。
表4消炎粉对压疮模型大鼠血清SOD含量的影响
与正常组比较,*P<0.05,与模型组比较,#P<0.05,与发明组比较,▷P<0.05
消炎粉对压疮模型大鼠血清EGF含量的影响
表5消炎粉对压疮模型大鼠血清EGF含量的影响
与正常组比较,*P<0.05,与模型组比较,#P<0.05,与发明组比较,▷P<0.05
通过本发明消炎粉的实验研究可以发现,其对于压疮导致的各项生化指标的影响具有很好的调节作用,效果优于阳性对照药物,通过对消炎粉主要药物甲硝唑、珍珠母、烟灰的消除使用,其效果显著降低,说明本发明消炎粉主要成分配合使用的科学性及不可或缺性,综合分析,本发明消炎粉在完成相关安全性评价后,适用于临床推广应用。
典型病例
崔某某男81岁脑梗塞后遗症入院
患者糖尿病足,左脚拇指末端坏死,干湿混合型坏疽,基底黑色,少量渗出,碘伏冲洗消毒后给予0.9%氯化钠注射液冲洗皮肤表面,待干后涂抹实施例1制备的消炎粉1,覆盖无菌纱布,绷带包扎,每日换药1次,1周后干湿性坏疽转干性坏疽,伤口表面干燥,坏死部分局限未扩散,效果好。
纪某某女89岁脑梗塞入院
患者左后腰压疮爬皮期,伤口2.5×2cm大小,基底粉红色,边缘整齐,周围皮肤无浸渍。使用0.9%氯化钠注射液冲洗伤口,待干后给予实施例1制 备的消炎粉1覆盖伤口表面,覆盖无菌纱布,每日换药1次,15天后伤口1×1cm大小,愈合状况良好。
宋某某女87岁脑梗死后遗症入院
患者入院,体型较胖,查全身皮肤情况发现颈部两侧,双腋下,两侧腹股沟皮肤浸渍、潮红严重,给予0.9%氯化钠注射液清洗皮肤表面,待干后涂抹实施例1制备的消炎粉1一日两次,换药3天,皮肤无潮湿潮红,效果明显。
刘某某86岁缺血性心脏病入院
日患者***褶皱处出现长1cm皮肤破溃,无渗血渗出,碘伏消毒后给予0.9%氯化钠注射液清洗皮肤表面,待干后涂抹实施例1制备的消炎粉1,11天后伤口愈合。
阎某某女83岁缺血性心脏病入院
患者右下肢足部动脉闭塞重,右足部紫绀明显加重,脚背2处皮肤破溃,伤口1×1cm,0.6×0.6cm少量渗出,周围皮肤黑紫色,无浸渍,碘伏消毒后给予0.9%氯化钠注射液清洗皮肤表面,待干后涂抹实施例1制备的消炎粉1,无菌纱布覆盖,绷带包扎,每日换药一次,查看伤口表面干燥、无渗出。
李某某男88岁脑梗死后遗症
2.29日患者入院,查全身皮肤情况发现右侧腹股沟及阴囊根部潮湿、潮红,阴囊皮肤表面有一0.5×0.5cm大小皮肤破溃,碘伏消毒后给予0.9%氯化钠注射液清洗皮肤表面,待干后涂抹实施例1制备的消炎粉1一日两次,第一天皮肤潮红明显好转,同法使用12天后,阴囊皮肤破溃愈合,腹股沟皮肤无潮湿、潮红。
庞某某女83岁
患者骶尾压疮爬皮期,伤口2×1.5cm大小,基底粉红色,无渗出。使用0.9%氯化钠注射液冲洗伤口,待干后给予实施例1制备的消炎粉1覆盖伤口表面,覆盖无菌纱布,每日换药1次,5天后伤口完全愈合。
谭某女97岁脑出血后遗症入院
患者左手拇指外侧皮肤擦伤,伤口0.5×3cm大小,少量渗血,碘伏消毒,给予0.9%氯化钠注射液清洗皮肤表面,待干后涂抹消炎粉覆盖伤口表面,无菌纱布绷带包扎,次日伤口表面结痂、无渗血,同法给予碘伏消毒,0.9%氯 化钠注射液将伤口表面冲洗干净,待干后涂抹实施例1制备的消炎粉1覆盖,无菌纱布绷带包扎,每日换药1次,7天后伤口完全愈合。
吕某某女71岁脑梗死后遗症入院
患者右脚外侧压疮爬皮期,伤口1×1.5cm大小,基底粉红色,无渗出。使用0.9%氯化钠注射液冲洗伤口,待干后给予实施例1制备的消炎粉1覆盖伤口表面,无菌纱布绷带包扎,每日换药1次,3天后伤口完全愈合。
葛某某男83岁缺血性心脏病
患者后背压疮愈合末期形成窦道,长2cm,每日使用0.9%氯化钠注射液冲洗伤口,给予实施例1制备的消炎粉1填塞,无菌纱布覆盖伤口表面,伤口少量渗出,周围皮肤无浸渍,每日换药2次,持续换药5天。第6天伤口无渗出,周围皮肤无浸渍,改每日换药1次,16天后伤口愈合。
宫某某女73岁缺血性心脏病
患者右脚伤口爬皮期,伤口3×2cm大小,基底粉红色,无渗出,伤口边缘整齐。使用0.9%氯化钠注射液冲洗伤口,待干后给予实施例1制备的消炎粉1覆盖伤口表面,无菌纱布绷带包扎11天,伤口完全愈合。
所有上述的首要实施这一知识产权,并没有设定限制其他形式的实施这种新产品和/或新方法。本领域技术人员将利用这一重要信息,上述内容修改,以实现类似的执行情况。但是,所有修改或改造基于本发明新产品属于保留的权利。
以上所述,仅是本发明的较佳实施例而已,并非是对本发明作其它形式的限制,任何熟悉本专业的技术人员可能利用上述揭示的技术内容加以变更或改型为等同变化的等效实施例。但是凡是未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与改型,仍属于本发明技术方案的保护范围。
Claims (5)
1.一种用于促进Ⅰ期、Ⅱ期压疮愈合、预防压疮Ⅲ期的消炎粉,其特征在于:原料药由甲硝唑粉、珍珠粉、烟灰、地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、蜂房、龙血竭、白头翁、生黄芪、透骨草构成;
所述各成分的重量比为甲硝唑粉:珍珠粉:烟灰:地肤子:白鲜皮:蛇床子:滑石:煅牡蛎:蜂房:龙血竭:白头翁:生黄芪:透骨草=2:1:1:1.25:1.25:1.25:1.25:1.25:0.6:0.6:0.6:1.5:0.75。
2.权利要求1所述消炎粉的制备方法,其特征在于,包括:
第一步,甲硝唑粉、珍珠粉、烟灰采用中药超微粉碎机分别粉碎成200目的粉末,备用;
第二步,采用醇提法提取地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、蜂房、龙血竭、白头翁、生黄芪和透骨草形成的混合物,醇提液浓缩除去乙醇,干燥后亦放入中药超微粉碎机中粉碎成200目粉末;
第三步,将前两步获得的粉末混合到一起,加入适量载体,获得消炎粉。
3.如权利要求2所述消炎粉的制备方法,其特征在于:所述第二步进一步具体为分别按重量称取地肤子、白鲜皮、蛇床子、滑石、煅牡蛎、蜂房、龙血竭、白头翁、生黄芪和透骨草,混合在一起,加入相对于混合物质量3~4倍的醇浓度90%的乙醇,加热回流提取2小时,提取液过滤,滤渣再次加入相对于混合物质量2~3倍的醇浓度90%的乙醇,加热回流提取2小时,提取液合并,浓缩除去乙醇,干燥后放入中药超微粉碎机中粉碎成200目粉末。
4.如权利要求2或3所述消炎粉的制备方法,其特征在于:载体加入淀粉。
5.如权利要求4所述消炎粉的制备方法,其特征在于:淀粉的加入量是混合粉末质量的2倍至3倍。
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CN101288669A (zh) * | 2008-06-02 | 2008-10-22 | 陈铭 | 一种外用治疗压疮的药粉剂 |
CN101780209A (zh) * | 2010-02-26 | 2010-07-21 | 刘鑫 | 治疗截瘫压疮的外敷平疮膏 |
CN101822783A (zh) * | 2009-03-04 | 2010-09-08 | 魏蕙荣 | 一种外用治疗压疮的中西药粉剂 |
CN103816326A (zh) * | 2014-02-27 | 2014-05-28 | 河南中医学院 | 一种治疗难愈性压疮的中药油 |
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CN101288669A (zh) * | 2008-06-02 | 2008-10-22 | 陈铭 | 一种外用治疗压疮的药粉剂 |
CN101822783A (zh) * | 2009-03-04 | 2010-09-08 | 魏蕙荣 | 一种外用治疗压疮的中西药粉剂 |
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