CN106491568A - 一种治疗皮肤外伤及感染的海洋生物喷膜及其制备方法 - Google Patents
一种治疗皮肤外伤及感染的海洋生物喷膜及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种治疗皮肤外伤及感染的海洋生物喷膜及其制备方法,属于海洋生物医用材料领域。该生物喷膜的原料为壳聚糖、Ⅰ型胶原蛋白和中药提取物,其中中药提取物的原料有茯苓、熟地、白芍、白术、黄连、五倍子、白芷、没药、防风、羌活、独活、乳香、红花、冰片、当归、炙甘草。本发明生物喷膜对各种类型的皮肤创口具有迅速止血、杀菌、愈合等显著功效;其使用方便,可以家居常备,简化了伤口消毒、包扎等繁琐程序;并且,工艺简便易行、原料成本低廉、适合工业转化和推广应用。
Description
技术领域
本发明涉及一种治疗皮肤外伤及感染的海洋生物喷膜,属于海洋生物医用材料技术领域。
背景技术
由于皮肤处于人体的最外层,与外界各种因素直接接触,所以外伤发生频率非常高,常发生的有割伤、抓伤、砸伤、挤伤、擦伤、裂伤、刺伤、烧烫伤、蚊虫咬伤、酸碱腐蚀伤、外科手术伤口、褥疮等。不同的外伤采用不同的方法进行处理,如割伤是刀、剪、玻璃片或锋利的器具造成的损伤,通常处理方法是当刀割伤时,先用清洁的物品止血,再用绷带固定住,当伤口流血不止时,就要用直接压迫法止血,在出血停止后,再用75%酒精或碘酒消毒伤口周围的皮肤,再用消过毒的纱布或创可贴覆盖,最后用绷带包扎固定,若伤口较深较大或面部伤口应去医院处理,必要时予以缝合。整个过程就是清创(生理盐水、双氧水)→消毒(碘酒、75%酒精)→敷药(红药水、紫药水、消炎粉等)→包扎(消毒纱布),但临床发现,双氧水、碘酒、红药水等消毒药水会破坏肉芽组织,减少白血球活性,抑制伤口愈合,会造成疤痕,红药水和紫药水还可能使疤痕加深,所以要用这些药水消毒,现在的方法是伤口涂上这些药水后,马上迅速的用生理盐水把这些消毒药水冲洗干净才好,所以在这些消毒药水中生理盐水为最好,而生理盐水消毒的效果是有限的。为了改变上述的消毒、包扎等对皮肤有损伤的方法,医学界都在努力寻找治疗外伤的新药剂、新方法。
祖国的传统医学对外伤具有独到的疗效和见解,其在伤口恢复、组织愈合、患处的调理等方面有较强的治疗优势,但是其止血速度、见效速度往往较慢。海洋生物医用材料是近年来高分子材料研究的热点,其来源丰富廉价,具有良好的成膜性、良好的免疫原性、生物相容性、快速的止血凝血性等特点,逐渐受到国内外专家的重视。因而,发明人将两者有机的结合在一起,使海洋生物医用材料发挥迅速的成膜止血作用,同时又能让重要成分发挥调理愈合、活血生肌的良好作用,从而就发明了一种新型的喷膜,其对外伤可以迅速见效,标本兼治,获得了显著的技术成效和巨大的科技成果。
发明内容
本发明要解决的技术问题是为皮肤外伤及感染患者发明一种方便使用、疗效好的医学材料。为解决该技术问题,发明人所采取的解决方案为:利用海洋生物材料主要是壳聚糖、Ⅰ型胶原蛋白等为基质,添加组方中药提取物,通过长期的科研攻关和研究,利用通用的工业技术制成喷剂,在喷到皮肤患处表面的时候,形成一层具有很好疗效的海洋生物薄膜,从而可以简化治疗过程,方便携带使用。该喷膜的配方为(以重量份计):
壳聚糖8-40份、Ⅰ型胶原蛋白1-20份、中药提取物5-19份;
中药提取物:茯苓5-15份、熟地6-27份、白芍7-19份、白术8-30份、黄连7-27份、五倍子8-30份、白芷7-25份、没药6-24份、防风5-17份、羌活4-15份、独活4-13份、乳香6-20份、红花4-11份、冰片4-13份、当归3-11份、炙甘草4-15份。
在发明过程中优选出来的具有优异疗效的配方为(以重量份计):
壳聚糖18份、Ⅰ型胶原蛋白9份、中药提取物12份;
中药提取物:茯苓9份、熟地16份、白芍13份、白术13份、黄连17份、五倍子18份、白芷15份、没药16份、防风11份、羌活9份、独活8份、乳香12份、红花7份、冰片8份、当归7份、炙甘草9份。
本发明一种治疗皮肤外伤及感染的海洋生物喷膜的制备方法为以下步骤:
(1)按本发明配方分别准确称取各种原材料,备用,其中壳聚糖和Ⅰ型胶原蛋白均为符合国家标准的成品原料;
(2)将没药、乳香、冰片、炙甘草分别粉碎,磨细,过80-130目筛,得细粉,备用;
(3)将茯苓、熟地、白芍、白术、黄连、五倍子、白芷、防风、羌活、独活、红花、当归分别粉碎混合,加入初始药材4-16倍重量的纯化水,浸泡6-24小时,回流煎煮1-5小时,过滤,再加入初始重量3-12倍重量的纯化水,回流煎煮1-3小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.16-1.20的浓缩液备用;
(4)将步骤(3)的滤渣加3-12倍重量的浓度65-85%的乙醇,回流提取2次,每次1-5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.16-1.20的浓缩液备用;
(5)将步骤(3)、(4)所得的浓缩液与步骤(2)所得细粉合并,混合均匀,继续浓缩至60℃相对密度为1.32-1.35的中药浸膏,即为中药提取物,备用;
(6)将壳聚糖、Ⅰ型胶原蛋白分别粉碎,磨细,过80-130目筛,得壳聚糖细粉和Ⅰ型胶原蛋白细粉,备用;
(7)将步骤(6)的壳聚糖细粉加3-16倍的1-45%的乳酸,溶解搅拌1-3小时,过滤,得澄清溶液,备用;
(8)按配比准确称取步骤(5)的中药提取物,加入步骤(7)的澄清溶液和步骤(6)的Ⅰ型胶原蛋白细粉,混和均质,得悬浊液,即为原料喷膜;
(9)将原料喷膜添加适当的辅料,利用现代通用的药品制剂技术,制成瓶装喷膜,即为成品。此外,也可以将原料喷膜添加适当的辅料制成软膏剂、贴剂、搽剂、酊剂、膏药等临床常用剂型的药品。
本发明所用原材料的来源、功效特点等介绍:
壳聚糖:壳聚糖作用及其机理
(1)为创伤面提供了一个优良的保护层
壳聚糖具有良好的成膜性,由于分子量大成膜性能强,是生物护伤喷膜剂中主要的成膜物质。当壳聚糖生物护伤喷膜剂喷到创伤面时,对伤口有很好的亲和性。会在创伤面上形成一层薄膜,由于这种膜在刚喷到创伤面时,呈半流动状态,且具有流动性,所以这层薄膜会对凹凸不平的创伤面进行全覆盖,从而为创伤面形成了一种保护层,阻止真菌、细菌等有害微生物及脏物与创伤面接触。这种膜具有一定的透气性、透湿性,既为创伤面提供了保护层,又为创伤组织提供了适合生长的良好环境,使创伤面收敛,渗出物减少,痂面干燥,从而加速了伤口的愈合。
(2)提供了皮肤中的组成物质
氨基葡萄糖和N-乙酰氨基葡萄糖是皮肤中主要的成分之一。而氨基葡萄糖和N-乙酰氨基葡萄糖是壳聚糖基本单位,当喷膜剂中的壳聚糖与伤口接触时,由于创面愈合早期会分泌出溶菌酶和蛋白酶,这两种酶会降解壳聚糖生成氨基葡萄糖和N-乙酰氨基葡萄糖,补充了皮肤中这两种成分,同时还对巨噬细胞有刺激作用,提高了局部免疫调节作用,增强抗感染能力,可加速伤口的愈合。
(3)能抑制杀害病原菌,防止创面感染
壳聚糖对大肠杆菌、金黄色葡萄球菌和白色念珠菌等有害的病原菌有很强的抑杀作用。当喷膜剂中的壳聚糖与伤口接触时,附着在伤口表面和伤口中的病原菌将被抑杀,防止伤口的感染。
(4)促使细胞生长,修复受伤细胞,加速伤口愈合
壳聚糖在动植物生命活动过程中应用时,最大特点是能直接针对细胞起作用,当喷膜剂中的壳聚糖与伤口接触时,由于壳聚糖是优良的细胞生长诱导因子和细胞的高效活化因子,所以当壳聚糖与伤口的细胞和受伤的细胞接触时,迅速发挥作用。
(5)对伤口有很好的止血作用、止痛作用
壳聚糖有很好的止血作用,这对伤口的处理有重要意义,止住伤口流血是治疗创伤的主要措施,当喷膜剂中的壳聚糖与流血的创面接触时,由于带正电荷的壳聚糖与细胞表面带负电荷的神经氨基酸残基的受体发生相互作用促进血小板的凝集,从而起到止血作用,同时壳聚糖可以与红细胞膜之间产生相互作用,促使红细胞凝集,从而达到止血的作用。壳聚糖由于能吸收血管舒缓激肽而起到止痛作用,同时壳聚糖吸收了酸性物质在发炎部位释放出来的质子,也有止痛作用。
(6)促进皮肤组织修复和愈合
创面愈合过程主要包括血小板凝集、血液凝固、纤维蛋白形成、炎性反应发生、细胞增殖和再生、受损组织修复和重塑。
Ⅰ型胶原蛋白:胶原蛋白是生物高分子,动物结缔组织中的主要成分,也是哺乳动物体内含量最多、分布最广的功能性蛋白,占蛋白质总量的25%-30%,某些生物体甚至高达80%以上。Ⅰ型胶原蛋白是鱼皮和鱼骨中所含的胶原蛋白,其价格相对较低,而医用价值却很高。胶原蛋白是肌体自然蛋白,对皮肤表面的蛋白质分子具有较大的亲和力、较弱的抗原性、良好的生物相容性和生物降解安全性,可降解吸收,粘着力好。由胶原制成的手术缝合线既有与天然丝一样的高强度,又有可吸收性,在使用时既有优良的血小板凝聚性能,止血效果好,又有较好的平滑性和弹性,缝合结头不易松散,操作过程中不易损伤机体组织,对创面有很好的黏附性,一般情况下只需较短时间的压迫就可达到满意的止血效果。所以胶原蛋白可以制成粉状、扁状及海绵状的止血剂。同时用合成材料或胶原蛋白在血浆代用品、人造皮肤、人工血管、骨的修复和人工骨和固定化酶的载体等方面的研究和应用方面都十分的广泛。
茯苓:本品为多孔菌科真菌茯苓的干燥菌核。味甘、淡,性平;归心、脾、肾经;渗湿利水、健脾和胃、宁心安神。
熟地:本品为生地黄的炮制加工品。味甘,性微温;归肝、肾经;滋阴补血,益精填髓。
白芍:本品为毛茛科植物芍药的干燥根。味苦、酸,性微寒;归肝、脾经;平肝止痛,养血调经,敛阴止汗。
白术:本品为菊科植物白术的干燥根茎。味苦、甘,性温;归脾、胃经;健脾益气,燥湿利水,止汗,安胎。
黄连:本品为毛茛科植物黄连、三角叶黄连或云连的干燥根茎。味苦,性寒;归心、脾、胃、肝、胆、大肠经;清热燥湿,泻火解毒。
五倍子:本品为漆树科植物盐肤木、青麸杨或红麸杨叶上的虫瘿,主要由五倍子蚜寄生而形成。味酸、涩,性寒;归肺、大肠、肾经;敛肺降火,涩肠止泻,敛汗止血,收湿敛疮。
白芷:本品为伞型科植物白芷或杭白芷的干燥根。味辛,性温;归胃、大肠、肺经;散风除湿,通窍止痛,消肿排脓。
没药:橄榄科没药属植物没药树及同属他种植物的树干皮部渗出的油胶树脂。味苦,性平;入肝经;散瘀止痛,外用消肿生肌。
防风:本品为伞形科植物防风的干燥根。味辛、甘,性温;归膀胱、肝、脾经;解表祛风,胜湿,止痉。
羌活:本品为伞形科植物羌活(背翅芹)或宽叶羌活的干燥根茎及根。味辛、苦,性温;归膀胱、肾经;散寒,祛风,除湿,止痛。
独活:本品为伞形科植物重齿毛当归的干燥根。味辛、苦,性微温;归肾、膀胱经;祛风除湿,通痹止痛。
乳香:橄榄科乳香树属植物乳香树、药胶香树及野乳香树等,以其树干皮部伤口渗出的油胶树脂入药。味辛苦,性温;入心、肝、脾经;调气活血,定痛,追毒。
红花:别名红蓝花 、刺红花,菊科、红花属植物。味辛,性温;入心、肝经;活血通经,去瘀止痛。
冰片:分机制冰片与艾片两类。机制冰片以松节油、樟脑等为原料经化学方法合成的龙脑;艾片为菊科艾纳香属植物大风艾的鲜叶经蒸气蒸馏、冷却所得的结晶,又称“艾粉”或“结片”。味辛、苦,性微寒;归心、脾、肺经;开窍醒神,清热止痛。
当归:本品为伞形科植物当归的干燥根。味甘、辛,性温;归肝、心、脾经;补血活血,调经止痛,润肠通便。
炙甘草:本品为豆科植物甘草、胀果甘草或光果甘草的干燥根。味甘,性平;归心、肺、脾、胃经;补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。
本发明喷膜的配方原理及功效解析:
本发明配方中使用了一个中药组方,该中药组方的配伍原理为:以五倍子、黄连、熟地、没药为君药,收湿敛疮、泻火解毒、养血调经、消肿生肌;以白芷、白芍、白术、乳香为臣药,消肿排脓、平肝止痛、燥湿利水、定痛追毒;以红花、冰片、独活、羌活为佐药,活血通经、清热止痛、通痹止痛、祛风除湿;以防风、茯苓、当归为使药,解表祛风、渗湿利水、补血活血;以甘草调和诸药性,使君臣佐使诸药相偕,阴阳调和,表里共用,从而达到收湿敛疮、泻火解毒、养血调经、消肿生肌、通痹排脓、定痛追毒、清热止痛、解表祛风、渗湿利水、补血活血等功效。此外,壳聚糖除了具有良好的成膜作用外,还具有杀菌、促进伤口愈合、止血止痛等功效,Ⅰ型胶原蛋白具有良好的生物相容性、凝血作用等,二者与中药提取物相配合从而可以达到,在患处皮肤表面形成一层具有凝血止痛、去腐生肌、杀菌消毒、活血化瘀等功效的薄膜,从而对各种外伤,割伤、抓伤、砸伤、挤伤、擦伤、裂伤、刺伤、烧烫伤、蚊虫咬伤、酸碱腐蚀伤、外科手术伤口、褥疮、疔疮、疥疮等皮肤感染,蚊虫叮咬发炎等均有十分显著的疗效。
与现有技术相比,本发明喷膜具有以下技术优势:
(1)疗效好:对各种类型的皮肤创口具有迅速止血、杀菌、愈合等显著功效;
(2)使用方便:瓶装喷膜便于携带,可以家居常备,简化了伤口消毒、包扎等繁琐程序,将伤口清理,直接喷上本品,即可;
(3)本发明工艺简便易行、原料成本低廉、适合工业转化和推广应用。
具体实施方式
实施例1
为了证明本发明喷膜配方和工艺的可行性,并为后续的一系列试验提供样品,发明人选取几个有代表性的配方配比进行了实践生产,各配方配比如表1所示。
表1 各配方配比表
(1)按表1所示配方配比分别准确称取各种原材料,其中壳聚糖和Ⅰ型胶原蛋白均为符合国家标准的成品原料,备用;
(2)将没药、乳香、冰片、炙甘草分别粉碎,磨细,过100目筛,得细粉,备用;
(3)将茯苓、熟地、白芍、白术、黄连、五倍子、白芷、防风、羌活、独活、红花、当归分别粉碎混合,加入初始药材12倍重量的纯化水,浸泡12小时,回流煎煮3小时,过滤,再加入初始重量8倍重量的纯化水,回流煎煮2小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.16-1.20的浓缩液备用;
(4)将步骤(3)的滤渣加8倍重量的浓度75%的乙醇,回流提取2次,每次2小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.16-1.20的浓缩液备用;
(5)将步骤(3)、(4)所得的浓缩液与步骤(2)所得细粉合并,混合均匀,继续浓缩至60℃相对密度为1.32-1.35的中药浸膏,即为中药提取物,备用;
(6)将壳聚糖、Ⅰ型胶原蛋白分别粉碎,磨细,过100目筛,得壳聚糖细粉和Ⅰ型胶原蛋白细粉,备用;
(7)将步骤(6)的壳聚糖细粉加11倍的10%的乳酸,溶解搅拌2小时,过滤,得澄清溶液,备用;
(8)按配比准确称取步骤(5)的中药提取物,加入步骤(7)的澄清溶液和步骤(6)的Ⅰ型胶原蛋白细粉,混和均质,得悬浊液,即为原料喷膜;
(9)将原料喷膜添加适当的辅料,利用现代通用的药品制剂技术,制成瓶装喷膜,规格:80g/瓶,中药含量:56.8g生药/瓶。
实施例2
毒性试验
1皮肤刺激实验
(1)实验方法
将豚鼠背部脊柱两侧将脱毛剂均匀涂上,使去毛范围约20cm2。洗净脱毛剂,归笼观察24小时,实验3个组的豚鼠在脱毛区分别喷上本发明实施例1按优选值生产的喷膜,3g、6g和12g,另一组涂溶媒0.8ml每日两次,连续一周,实验结束后,将豚鼠处死,心,肝,肾及脱毛皮肤做病理检验。
(2)结果
上述3组用药豚鼠躯干脱毛区,未见局部皮肤有水肿、充血、红斑、出血点及溃疡。用药组豚鼠毛发色泽、摄食、四肢活动等对照组无明显差异,病理组织学检查,给药组心、肝、肾及脱毛皮与对照字比较也无明显差异。结果提示,本发明喷膜无局部刺激作用,也未见全身毒性表现。表明本发明喷膜使用安全。
2动物急性毒性试验研究:
本发明喷膜经预试验,不能测出LD50,故测定最大给药量。采用灌胃给药途径,测得小鼠的一日最大给药量为82.4g/kg(以生药计),约为拟临床人用量(临床人用量为0.13g生药/kg/d)的633.8倍(人以60kg计)。实验动物均连续观察一周,其外观体征、精神状态、饮食、饮水、粪便等均未见明显异常。实验结束时,动物均健康存活,体重增加。又本品为外用品,因而,安全性更高。
3动物长期毒性试验研究:
实验设计本发明实施例1制备的药物高、中、低剂量组、基质对照组和空白对照组,采用灌胃给药途径给予大鼠,以最大灌胃给药剂量76.6g/kg(以生药计),相当于拟临床病人外用量的589.2倍,连续给药3个月,在给药过程中,各给药组及基质组大鼠的体重、饮食量、外观体征、行为活动、精神状态、毛色、粪便性状与空白对照组比较,无明显差异(p>0.05),动物体重增长值和主要脏器系数与空白对照组比较差异不显著(p>0.05),血液学和血液生化指标检查结果给药组个别指标与空白对照组比较差异显著(p<0.05),但恢复期结束后有差异的血液学和血液生化指标均已恢复正常,其他指标与空白对照比较差异不显著(p>0.05),给药期和恢复期组织学检查高剂量组动物主要脏器与空白对照组比较未见明显差异,未见迟缓性毒性出现。
通过以上实验,说明本发明生物喷膜临床应用是安全的。
实施例3
临床试验
1一般资料
此次临床试验的受试者,来自某市第二人民医院外科和皮肤科,共有396例患者自愿参与了本次临床试验,其中外伤180例、褥疮78例、疔疮和疥疮82例、蚊虫叮咬56例,每种病症的患者均平均分成两个组(对照组和试验组),使这两个组在性别、年龄、病情严重程度等方面具备统计学意义上的可比性。
2试验用药
对照药:
(1)治疗外伤常用清理、消炎和包扎缝合用品;
(2)褥疮清理措施,碘伏等治疗手段;
(3)强生硫软膏,国药准字H61020512;
(4)红霉素软膏;
试验样品:本发明实施例1以优选值所生产的生物喷膜,规格:80g/瓶,中药含量:56.8g生药/瓶。
3试验方法
对于外伤和褥疮的对照组患者,均按医院的常规清理、缝合、消炎、包扎等处理方式进行治疗;对于这两类患者的试验组,在进行常规清理、缝合后,喷涂试验样品,每日两次,间隔8小时,不用包扎。对于疔疮和疥疮的对照组患者,使用强生硫软膏进行涂抹,试验组患者使用试验样品喷涂,均每日2次,间隔8小时以上。对于蚊虫叮咬对照组患者,使用红霉素软膏,试验组使用试验样品,均每日2次,间隔8小时以上。所有各组患者均连续治疗两周,治疗结束以后,统计治疗结果。
4评判标准
治愈:患者患处完全愈合;
有效:患者的患处明显缩小,病况明显改善;
无效:患者的痛患没有明显改善,甚至更加严重。
5治疗结果统计
试验全部结束以后,对所有患者的治疗情况统计分析如表2所示。
表2 试验结果统计分析表
6结论
表2试验结果统计分析显示,对于外伤,试验组的治愈率比对照组提高了13.3个百分点,并且其治疗时不用包扎等繁琐的程序;对于褥疮,试验组的治愈率比对照组提高了20.5个百分点,总有效率提高了10.3个百分点;对于疔疮和疥疮,试验组的治愈率比对照组提高了31.7个百分点,总有效率提高了12.2个百分点;对于蚊虫叮咬,试验组的治愈率比对照组提高了25个百分点,总有效率提高了17.8个百分点。因此,与现有技术相比,本发明生物喷膜在对上述各种皮肤创口的治疗时均表现出了十分显著的技术优势,它以一种医药材料的形式对多种皮肤的疾患均有85%以上的有效率,并且大大简化了治疗的流程,患者的依从性更佳。因此,本发明生物喷膜在其所在的领域取得了突破性的技术进展和丰硕的科研成果,其创造性是不言而喻的。
Claims (5)
1.一种治疗皮肤外伤及感染的海洋生物喷膜,其特征在于,所述生物喷膜的配方以重量份计为:壳聚糖8-40份、Ⅰ型胶原蛋白1-20份、中药提取物5-19份;
所述中药提取物配方为:茯苓5-15份、熟地6-27份、白芍7-19份、白术8-30份、黄连7-27份、五倍子8-30份、白芷7-25份、没药6-24份、防风5-17份、羌活4-15份、独活4-13份、乳香6-20份、红花4-11份、冰片4-13份、当归3-11份、炙甘草4-15份。
2.如权利要求1所述的一种治疗皮肤外伤及感染的海洋生物喷膜,其特征在于,所述生物喷膜配方以重量份计为:壳聚糖18份、Ⅰ型胶原蛋白9份、中药提取物12份;
所述中药提取物配方为:茯苓9份、熟地16份、白芍13份、白术13份、黄连17份、五倍子18份、白芷15份、没药16份、防风11份、羌活9份、独活8份、乳香12份、红花7份、冰片8份、当归7份、炙甘草9份。
3.如权利要求1或2所述的一种治疗皮肤外伤及感染的海洋生物喷膜,其特征在于,所述生物喷膜的制备方法为以下步骤:
(1)按配方分别准确称取各种原材料,备用,其中壳聚糖和Ⅰ型胶原蛋白均为符合国家标准的成品原料;
(2)将没药、乳香、冰片、炙甘草分别粉碎,磨细,过80-130目筛,得细粉,备用;
(3)将茯苓、熟地、白芍、白术、黄连、五倍子、白芷、防风、羌活、独活、红花、当归分别粉碎混合,加入初始药材4-16倍重量的纯化水,浸泡6-24小时,回流煎煮1-5小时,过滤,再加入初始重量3-12倍重量的纯化水,回流煎煮1-3小时,过滤并保留滤渣,合并滤液,浓缩至60℃相对密度为1.16-1.20的浓缩液备用;
(4)将步骤(3)的滤渣加3-12倍重量的浓度65-85%的乙醇,回流提取2次,每次1-5小时,过滤,合并滤液,减压蒸馏除去乙醇,并浓缩至60℃相对密度为1.16-1.20的浓缩液备用;
(5)将步骤(3)、(4)所得的浓缩液与步骤(2)所得细粉合并,混合均匀,继续浓缩至60℃相对密度为1.32-1.35的中药浸膏,即为中药提取物,备用;
(6)将壳聚糖、Ⅰ型胶原蛋白分别粉碎,磨细,过80-130目筛,得壳聚糖细粉和Ⅰ型胶原蛋白细粉,备用;
(7)将步骤(6)的壳聚糖细粉加3-16倍的1-45%的乳酸,溶解搅拌1-3小时,过滤,得澄清溶液,备用;
(8)按配比准确称取步骤(5)的中药提取物,加入步骤(7)的澄清溶液和步骤(6)的Ⅰ型胶原蛋白细粉,混和均质,得悬浊液,即为原料喷膜;
(9)将原料喷膜添加适当的辅料,利用现代通用的药品制剂技术,制成瓶装喷膜,即为成品。
4.如权利要求3所述的一种治疗皮肤外伤及感染的海洋生物喷膜,其特征在于:所述生物喷膜可以将原料喷膜添加适当的辅料,制成软膏剂、贴剂、搽剂、酊剂、膏药等临床常用剂型的药品。
5.如权利要求1或2所述的一种治疗皮肤外伤及感染的海洋生物喷膜,其特征在于:所述生物喷膜可以用于治疗割伤、抓伤、砸伤、挤伤、擦伤、裂伤、刺伤、烧烫伤、蚊虫咬伤、酸碱腐蚀伤、外科手术伤口、褥疮、疔疮、疥疮。
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