WO2016115768A1 - 一种生肌长皮烧伤药膏及其制备方法 - Google Patents

一种生肌长皮烧伤药膏及其制备方法 Download PDF

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WO2016115768A1
WO2016115768A1 PCT/CN2015/074275 CN2015074275W WO2016115768A1 WO 2016115768 A1 WO2016115768 A1 WO 2016115768A1 CN 2015074275 W CN2015074275 W CN 2015074275W WO 2016115768 A1 WO2016115768 A1 WO 2016115768A1
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parts
ointment
vitamin
burn
myogenic
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French (fr)
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张金安
张壮一
张闻一
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张金安
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Priority to US15/542,420 priority Critical patent/US20180021343A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
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    • A61K31/33—Heterocyclic compounds
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    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
    • A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
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    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
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    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/08—Oxides; Hydroxides
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/48—Reproductive organs
    • A61K35/50—Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A61K35/64—Insects, e.g. bees, wasps or fleas
    • A61K35/644—Beeswax; Propolis; Royal jelly; Honey
    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/539—Scutellaria (skullcap)
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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    • A61K2236/50—Methods involving additional extraction steps
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Definitions

  • the invention relates to a myogenic long skin burn ointment and a preparation method thereof.
  • the skin damage caused by the burn itself or the new skin damage caused by the treatment process can easily cause problems such as pigmentation and scar residue.
  • skin grafting is needed, which not only aggravates the patient's pain, but also is expensive.
  • the Chinese patent with the patent number ZL95118978.6 is the early research result of the present inventor, which discloses an anti-inflammatory analgesic burn ointment, which adopts antibiotics and traditional Chinese medicine combination, has strong anti-infection effect, good analgesic effect, and can shorten wound healing period. Can effectively reduce the incidence of scars.
  • the healing time for deep II degree wounds is generally 4-13 days, which is significantly shorter than that of the control group using MEBO wet burn plaster, but the healing days for III degree burns are still longer, 21-30 days. .
  • the object of the present invention is to provide a myogenic long skin burn ointment capable of effectively shortening the degree of burn healing of III degree, no scar residue and effectively reducing the suffering of the patient, and providing a preparation method thereof, which can solve "II"
  • the world's problem is that the burn does not leave the sputum, the third degree burn does not skin graft, and the skin graft is replaced by the coated skin.
  • the present invention adopts the following technical solutions:
  • a myogenic long skin burn ointment comprising the following components by weight: 5-15 parts of cephalosporin, 5-15 parts of gentamicin, 5-20 parts of ginseng, 10-20 parts of propolis, comfrey 5 -20 parts, 10-20 parts of astragalus, 10-20 parts of montmorillonite, 6-20 parts of rhubarb, 10-20 parts of human placenta tissue solution, 0.5-5 parts of borneol, 5-15 parts of vitamin B6, vitamin C 8-15 200 parts of ointment base.
  • the cephalosporin is cefoperazone sodium.
  • the susceptibility test can be based on the bacterial culture choose other antibiotics.
  • the ointment base is a vaseline or W/O type matrix.
  • the human placenta tissue fluid can be selected from commercially available products, such as the human placenta tissue fluid approved by the company, which is approved by the company as “National Medicine Standard S13020002”.
  • the invention also provides a preparation method of the myogenic long skin burn ointment, the steps of which are as follows:
  • the exposure treatment is used, and after the general cleaning treatment of the burn wound, the blisters are blistered and discharged, and the burnt ointment and the necrotic tissue which are mistaken in the conventional therapy are not torn off, and the burn ointment is uniformly Apply to the wound surface, the next day, apply the ointment on the original surface (the original ointment does not need to be removed), and then repeatedly apply until the drug is sputum, until the wound is removed and the original appearance is restored.
  • the invention combines the proper compatibility of each drug component, effectively kills bacteria remaining or propagated in the damaged skin tissue, eliminates the cause of acute infection, and also has a good skin growth and long skin action, and the drug has strong transdermal absorption. Significantly reduce the wound exudate, can quickly repair the damaged tissue, accelerate the healing of the wound, significantly shorten the healing days of the III degree burn, and effectively avoid the regeneration of granulation tissue, inhibit the growth of large fibroblasts, prevent The formation of scars.
  • the ointment of the invention also has a good analgesic effect, greatly alleviating the pain caused by the pain caused by the burn, and effectively avoiding the physiological and pathological negative effects of the burn pain on the patient.
  • Treatment routine disinfection, external application of the burn ointment of the present invention, the patient washes the light on the fifth day, the face is as ordinary.
  • This example includes the following components: 15 g of cefoperazone sodium, 15 kg of gentamicin, 15 kg of vitamin C, 615 kg of vitamin B, 20 kg of ginseng, 20 kg of jaundice, 20 kg of propolis, 20 kg of comfrey, 6 kg of rhubarb, 6 kg of rhubarb 20 kilograms of montmorillonite, 10 kilograms of human placenta tissue fluid, 5 kilograms of borneol, and 200 kilograms of ointment base.

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Abstract

一种生肌长皮烧伤药膏包括如下原料(按重量份)：头孢菌素(5-15)、庆大霉素(5-15)、人参(5-20)、蜂胶(10-20)、紫草(5-20)、黄芩(10-20)、蒙脱石(10-20)、大黄(6-20)、人胎盘组织液(10-20)、冰片(0.5-5)、维生素B6(5-15)、维生素C(8-15)、软膏基质(200)。该药膏能够快速修复局部被损组织，加速创面的愈合，缩短Ⅲ度烧伤的愈合天数。

Description

一种生肌长皮烧伤药膏及其制备方法 技术领域
本发明涉及一种生肌长皮烧伤药膏及其制备方法。
技术背景
烧伤是一种危害人类健康和容貌的常见病。烧伤本身造成的皮肤损伤或者治疗过程中导致的新的皮肤损伤，很容易造成色素沉着、疤痕残留等容貌问题，最后多需植皮整容，不仅加重病人痛苦，且费用昂贵。
烧伤后次日，由于病人烧伤部位会出现水泡式皮损，重度肿胀，按照传统疗法，需撕皮包扎，肿胀加重需手术切开减胀，这会加重病人痛苦，给病人火上浇油。
国内外传统治疗烧伤是在进行一般的创面清洁处理后，然后剪掉视为腐皮及坏死组织的水泡组织，包扎保护、分期切痂植皮等保守疗法，并辅以静脉注射抗生素。数次切痂植皮，病人痛苦异常，并且费用昂贵，最后多需整形美容，治疗期延长，容易造成伤口感染。目前通用的暴露疗法在抑制大量细菌繁殖的同时，也导致人体正常细胞的分裂增生受阻，因而不利于烧伤创面的修复和再生，容易造成疤痕残留，病程变长，需过“三关”，死里逃生。
专利号为ZL95118978.6的中国专利是本发明人的早期研究成果，其公开了一种消炎止痛烧伤药膏，采用抗生素和中药中西结合，抗感染作用强，镇痛效果好，可缩短创面愈期，能有效降低疤痕发生率。其对于深Ⅱ度创面愈合天数一般为4-13天，较使用“美宝”湿润烧伤膏药的对照组愈合天数明显缩短，但其对于Ⅲ度烧伤的愈合天数仍较长，为21-30天。
发明内容
针对以上技术问题，本发明的目的是提供一种能有效缩短Ⅲ度烧伤愈合天数、无瘢痕残留且有效减轻病人痛苦的生肌长皮烧伤药膏，并提供其制备方法，该药膏能解决“Ⅱ度烧伤不留疤，Ⅲ度烧伤不植皮”的世界难题，用涂药生肌长皮代替手术植皮。
为实现以上目的，本发明采用如下技术方案：
一种生肌长皮烧伤药膏，其包括如下重量份的组分：头孢菌素5-15份，庆大霉素5-15份、人参5-20份、蜂胶10-20份、紫草5-20份、黄芩10-20份、蒙脱石10-20份、大黄6-20份、人胎盘组织液10-20份、冰片0.5-5份、维生素B6 5-15份、维生素C 8-15份、软膏基质200份。
优选地，所述头孢菌素为头孢哌酮钠。对特殊病人，可根据其细菌培养药敏实验结 果选用其它抗生素。
优选地，所述软膏基质为凡士林或W/O型基质。
人胎盘组织液选用市售产品均可，如邯郸康业制药有限公司生产的批准文号为“国药准字S13020002”的人胎盘组织液。
本发明还提供了所述生肌长皮烧伤药膏的制备方法，其步骤如下：
(1)按所述重量份称取人参、蜂胶、紫草、黄芩和大黄，用75％酒精浸润18-24小时，晾干后，放入干燥箱内，在30-40℃温度下烘干，粉碎，过120目筛，待用；
(2)按所述重量份称取蒙脱石，研磨，过120目筛，加入所述冰片，研磨，待用；
(3)按所述重量份称取头孢菌素、庆大霉素、维生素B6和维生素C，混匀后加入步骤(1)和(2)所得混合物，混匀，最后加入人胎盘组织液和熔溶后的软膏基质，研匀即可。
本发明药膏在治疗时，采用暴露疗法，对烧伤创面进行一般的清洁处理后，将有水泡处穿泡放水，不撕掉传统疗法中误认为的腐皮及坏死组织，将该烧伤药膏均匀地涂在创面上，次日，在原创面上再补涂该药膏(原药膏不必清除)，如此反复涂抹，直至结药痂，待到痂脱伤愈，恢复原貌。
本发明通过各药物组分的合理配伍，在有效杀灭被损皮肤组织中残留或繁殖的细菌、消除急性感染病因的同时，还具有良好的生肌长皮作用，药物透皮吸收度强，明显减少创面渗出液，能够快速修复局部被损组织，加速创面的愈合，明显缩短了Ⅲ度烧伤的愈合天数，并有效地避免了肉芽组织的再生，抑制了大纤维母细胞生长，防止了疤痕的形成。此外本发明药膏还具有良好的镇痛效果，大大减轻了烧伤引起的疼痛给患者带来的痛苦，同时也有效地避免了烧伤疼痛给病人带来的生理、病理方面的负效应。
本发明药物所产生的积极效果从下述临床验证资料中得以证实。
一、烧伤病例的选择：
符合黄家驷所著《外科学》Ⅲ度烧伤者，按双盲随机法分为两组，实验组使用本发明药物，对照组使用“美宝”湿润烧伤膏。
二、疗效评定标准
1、创面感染的评定标准
按Pruitt(1979)所述创面感染
2、创面愈合的评定标准
按黄家驷所著《外科学》所定标准
3、瘢痕愈合评定标准
按黄家驷所著《外科学》所定标准
4、创面疼痛的评定标准
以15分钟后仍感到疼痛难耐，病人要求使用镇痛药为阳性统计对象。
三、临床观察结果
表1创面感染发生率对比情况
组别 总例数 感染数 感染率 P
实验组 180 0 0  
对照组 120 3 2.50％ <0.01
表2烧伤瘢痕发生率对比情况
组别 总例数 疤痕数 疤痕率 P
实验组 240 0 0  
对照组 240 128 53 <0.05
表3创面植皮率对比情况
组别 总例数 植皮数 植皮率 P
实验组 180 0 0  
对照组 120 2 1.57％ <0.05
表4创面疼痛发生率对比情况
组别 总例数 疼痛数 疼痛率 P
实验组 180 0 0  
对照组 120 38 31.6 <0.01
本发明与专利号为ZL95118978.6的中国专利对于Ⅲ度烧伤创面愈合天数的比较见表5(其中实验组为使用本发明药膏，对照组为使用ZL95118978.6的药膏)。
表5 Ⅲ度创面愈合天数对比情况。
Figure PCTCN2015074275-appb-000001
典型病例
1、张安生，男，38岁，山东省曹县桃园乡闫村人。
2014年11月26日下午15：30
主诉：面部烫伤半天
缘于当日11点，在家做饭时，高压锅爆炸，烫伤面部，当即到河北医大一院烧伤科喷药水、疼痛难忍、慕名求医。
查：面部潮红、存在水泡、Ⅲ度烫伤，坐立不宁，涂本发明药膏后片刻鼾声入睡。
处理：常规消毒、外涂本发明烧伤药膏，第5天患者洗光，面如常人。
2、谭剑，男，28岁，中国人民解放军军械工程学院保卫处，现役军人。
2007年5月25日
主诉面部烧伤6天
缘于6天前燃放火药烧伤面部及左上臂，当时被送解放军和平医院烧伤科住院，面貌全非，全面部焦痂，面肿如斗，为Ⅲ度烧伤，第六天烧伤科主任准备植皮，告知本人准备毁容破相，故慕求名医。经涂本发明药膏后，未植皮，10天治愈，面部无疤痕，色素无沉着，面如常人。
3、张日升，男，58岁。2014年12月1日在维修煤气管道时不慎失火，将面、颈部及双手深Ⅲ度烧伤，立即外涂湿润伤灵膏，次日面部及双手重度肿胀，面部皮肤大部脱落，疼痛难忍。外涂本发明药膏，未输液，未住院，六天治愈，未留疤痕，面貌如常。
具体实施方式
实施例1：
本实施例包括如下重量的组分：头孢哌酮钠15千克、庆大霉素15千克、维生素C 15千克、维生素B615千克、人参20千克、黄芩20千克、蜂胶20千克、紫草20千克、大黄6千克、蒙脱石20千克、人胎盘组织液10千克、冰片5千克、软膏基质200千克。
本实施例的制备方法为：
(1)按所述重量份称取人参、蜂胶、紫草、黄芩和大黄，用75％酒精浸润18-24小时，晾干后，放入干燥箱内，在30-40℃温度下烘干，粉碎，过120目筛，待用；
(2)按所述重量份称取蒙脱石，研磨，过120目筛，加入所述冰片，研磨，待用；
(3)按所述重量份称取头孢菌素、庆大霉素、维生素B6和维生素C，混匀后加入步骤(1)和(2)所得混合物，混匀，最后加入人胎盘组织液和熔溶后的软膏基质，研匀即可。
将蒙脱石研磨粉碎，过120目筛后，加入冰片，研均，待用；
将头孢哌酮、庆大霉素、复合维生素C，细粉混合后加入中草药粉、冰片粉混匀，最后加入 熔溶后的麻油，充匀研匀。
以下6个实施例药膏的制备方法同实施例1相同，只是药物组分配比有所不同，但疗效基本相同。
Figure PCTCN2015074275-appb-000002

Claims (4)

  1. 一种生肌长皮烧伤药膏，其特征在于：其包括如下重量份的组分：头孢菌素5-15份，庆大霉素5-15份、人参5-20份、蜂胶10-20份、紫草5-20份、黄芩10-20份、蒙脱石10-20份、大黄6-20份、人胎盘组织液10-20份、冰片0.5-5份、维生素B65-15份、维生素C 8-15份、软膏基质200份。
  2. 根据权利要求1所述的一种生肌长皮烧伤药膏，其特征在于：所述头孢菌素为头孢哌酮钠。
  3. 根据权利要求1所述的一种生肌长皮烧伤药膏，其特征在于：所述软膏基质为凡士林或W/O型基质。
  4. 权利要求1-3任一项所述的生肌长皮烧伤药膏的制备方法，其特征在于步骤如下：
    (1)按所述重量份称取人参、蜂胶、紫草、黄芩和大黄，用75％酒精浸润18-24小时，晾干后，放入干燥箱内，在30-40℃温度下烘干，粉碎，过120目筛，待用；
    (2)按所述重量份称取蒙脱石，研磨，过120目筛，加入所述冰片，研磨，待用；
    (3)按所述重量份称取头孢菌素、庆大霉素、维生素B6和维生素C，混匀后加入步骤(1)和(2)所得混合物，混匀，最后加入人胎盘组织液和熔溶后的软膏基质，研匀即可。
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