CN112957441A - 一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂及其制备方法 - Google Patents
一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂及其制备方法 Download PDFInfo
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Abstract
本发明属于中药技术领域,具体涉及一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂及其制备方法,包括以下重量份数的中药材原料:桂枝10‑50份;赤芍10‑50份;蓝姜10‑50份;黄姜10‑50份;了刁竹10‑30份;山胡椒10‑50份;棉花籽40‑100份;松香5‑20份;冰片5‑15份;透骨消10‑50份;铜钻20‑60份;小钻20‑60份;四方藤20‑60份;黄花倒水莲10‑50份;白芷10‑30份;风荷桂10‑50份和威灵仙10‑30份。本发明制备得到的外用药膜涂膜剂具有祛风除湿,温通经络,活血止痛的功效,对于风湿、类风湿、痛风等症有很好的治疗效果,对风湿痹痛,关节疼痛,肢体麻木,关节僵硬,屈伸不利以及风、寒、湿、痰、淤等引起的各种疼痛具有缓解及促进康复的保健作用;见效快、疗效好且安全性高,对人体无毒副作用。
Description
技术领域
本发明属于中药技术领域,具体涉及一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂及其制备方法。
背景技术
风湿类疾病是一组包括所有侵犯肌肉和骨骼系统、以疼痛为主要表现的疾病,如:风湿性关节炎、类风湿性关节炎、肌肉风湿痛、坐骨神经痛等。风湿类疾病具有发病率高、致病因素多样、病理变化复杂和治愈率低的特点。痛风是一种常见且复杂的关节炎类型,各个年龄段均可能罹患本病,痛风患者经常会在夜晚出现突然性的关节疼,发病急,关节部位出现严重的疼痛、水肿、红肿和炎症,疼痛感慢慢减轻直至消失,持续几天或几周不等。服用西药可以缓解疼痛,例如,治疗类风湿的药物包括非甾类抗炎药、慢作用抗风湿药、免疫抑制剂、免疫和生物制剂及植物药等,治疗风湿的药物包括非甾类抗炎药、肾上腺皮质激素、慢作用抗风湿药等,但这些药物对人体重要的脏器(肝、肾、膀胱、肺、胃肠、生殖腺)和组织(骨髓)各有不同的毒性作用。
当前,用于治疗风湿病、痛风或风、寒、湿、痰、淤等引起的各种疼痛的药物众多,包括西药和中药。西医治疗常以消炎止痛、激素、封闭等方法。其缺点是治标不治本,治疗时间长,疗效差,副作用大。中医一般采用内服中药,以舒筋活络、活血化瘀等方法,但内服中药难以长期坚持,苦涩难以入口,而且内服中药不方便,有的中药对胃还有刺激,产生不良的副作用。市场上也有各种各样的外用中药,疗效不一。
在祛风除湿、温通经络所用的外用药方面,检索到相关的文献如:1、申请号为200510126558.5的中国专利公开了一种活血化瘀、消肿止痛、祛风除湿的药物,该药物由山乌龟、穿破石、王不留行、大通筋、千斤拨、爬山虎、接骨木、威灵仙,经选料、烘干、粉碎后,混匀而成,该发明是一种外用药,药力强劲,透性强,治疗效果好,治愈率高,对人体无毒副作用,可以治疗风湿性关节炎,类风湿性关节炎,腰椎间盘突出,骨质增生,肩周炎,手足麻木,跌打损伤等病症。然后该外用药物在使用时需要将药粉先调成糊状,敷于患处并用绵软物质进行包裹,使用不太方便。2、申请号为 201010102297.4的中国专利公开了一种具有祛风除湿、消肿止痛的透皮贴剂及其制备方法,它是由背衬层、药物储存层和防粘层组成,该药物储存层由包括骨架材料 20-30% ;增粘剂 22-32% ;填充剂 25-35% ;润滑剂 6-13%;再添加 6-13%的药物,所述的该药物主要包括鸡血藤、四方木皮、汉桃叶、过岗龙、猪肚木皮、黑吹风等 30 多味中药制得的浸膏,按工艺步骤及比例混合后涂膏得到的痛肿灵透皮贴剂;该痛肿灵透皮贴剂的功效为祛风除湿、消肿止痛,临床上用于风湿骨痛和跌打损伤。该文献中制备得到的痛肿灵透皮贴剂虽然具有使用方便、疗效好的特点,但是其所用的中药材原料种类繁多,成本相对较高。
现代中医学认为:人体大部分的疾病产生都是经络长时间不通引起的;经络学说:起初是微循环故障产生,然后导致经络气血不通,形成结节或钙化点,导致经络气血瘀堵而出现痛症、麻木或活动受限等。“通则不痛,痛则不通”,若气血不畅,会引起肢体麻木、疼痛等各种症状。如风湿类疾病属中医痹症的范畴,中医理论认为痹症由风、寒、湿邪痹阻经络,气血运行不畅所致。目前,用于疏通经络、活血化瘀的内服或外敷中药组合物种类繁多,配制机理和药物配方也是多种多样,普遍存在的问题是疗效慢,治愈率低。 而且内服药的副作用比较强,在各种情况下,药物用得越多、时间越长,产生的副作用就越大。而外用药不用口服,只在局部起作用,可以有效减少口服药引发的胃肠道不适、吸收不良等反应等问题,且对全身的副作用比较小。
目前,我国有大量的风湿及骨、关节以及肌肉不适的患者,严重的可造成患者生活无法自理。因此,研究一种具有祛风除湿、温通经络,活血止痛功效,疗效好且副作用小,使用方便,成本低,可治疗风湿痹痛、关节僵硬、屈伸不利、腰膝酸软、疼痛等,适用于风湿、类风湿、痛风等症的外用药,具有重要意义。
发明内容
本发明的目的是针对上述现有技术所存在的问题,提供一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂及其制备方法。该外用药膜涂膜剂具有祛风除湿、温通经络、活血止痛的功效,见效快、疗效好且副作用小,使用方便,成本低,可用于治疗风湿病、痛风或风、寒、湿、痰、淤等引起的各种疼痛。
为实现上述目的,本发明采用如下技术方案:
一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂,包括以下重量份数的中药材原料:桂枝10-50份;赤芍10-50份;蓝姜10-50份;黄姜10-50份;了刁竹10-30份;山胡椒10-50份;棉花籽40-100份;松香5-20份;冰片5-15份;透骨消10-50份;铜钻20-60份;小钻20-60份;四方藤20-60份;黄花倒水莲10-50份;白芷10-30份;风荷桂10-50份和威灵仙10-30份。
进一步的,所述的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂,包括以下重量份数的原料:桂枝20-40份;赤芍20-40份;蓝姜20-40份;黄姜20-40份;了刁竹15-25份;山胡椒20-40份;棉花籽60-80份;松香10-15份;冰片8-12份;透骨消20-40份;铜钻30-50份;小钻30-50份;四方藤30-50份;黄花倒水莲20-40份;白芷15-25份;风荷桂20-40份;威灵仙15-25份以及足量的纯化水,足量的体积浓度为50-70%的乙醇溶液和足量的体积浓度为85%-95%的乙醇溶液。
本发明还提供了所述的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂的制备方法,具体制备步骤如下:
(1)中药浸膏的制备:分别将除杂、干燥后的各中药材原料粉碎成粗粉,过40目筛,按配方重量份数,量取各中药原料混合,用原料药质量6-8倍、体积浓度为50-70%的乙醇溶液浸渍2-4次,每次2-3天,合并浸渍液,过滤,滤液浓缩为60℃时相对密度为1.15-1.20的浸膏;
(2)成膜剂的准备:取50g 聚乙烯醇(PVA-1788),加入适量体积浓度为85%-95%的乙醇溶液浸泡12-14 h后,烘干,加适量纯化水在水浴上加热溶解,然后再加入35ml甘油,搅拌均匀,制得成膜剂;
(3)成品的制备:以重量份数计,取步骤(2) 制备得到的成膜剂3-5份,向其加入步骤(1) 制备的中药浸膏2-4份,同时加入羧甲基淀粉钠0.75-1.25份、氮酮0.35-0.65份、明胶0.75-1.25份、高岭土0.15-0.25份和二氧化钛0.2-0.4份,室温下搅拌机转速为50r/min搅拌30-35分钟,即得。
本发明所用的各味中药的药性如下:
桂枝, 为樟科植物肉桂 Cinnamomum cassia Presl的干燥嫩枝。春、夏二季采收,除去叶,晒干,或切片晒干。性味:辛、甘,温。归经:归心、肺、膀胱经。桂枝辛温,可祛风寒,能治疗感冒风寒、发热恶寒等。功能主治:发汗解肌,温通经脉,助阳化气,平冲降气。用于风寒感冒,脘腹冷痛,血寒经闭,关节痹痛,痰饮,水肿,心悸,奔豚。
赤芍,为毛茛科植物芍药Paeonia lactiflora Pall.或川赤芍Paeonia veitchiiLynch 的干燥根。春、秋二季采挖,除去根茎、须根及泥沙,晒干。性味:苦,微寒。归经:归肝经。有清热凉血,活血祛瘀的功效。功能主治:清热凉血,散瘀止痛。用于温毒发斑,吐血衄血,目赤肿痛,肝郁胁痛,经闭痛经,症瘕腹痛,跌扑损伤,痈肿疮疡。
蓝姜,姜科姜黄属植物黑心姜Curcuma caesia Roxb.,以根状茎入药。夏季采,洗净,鲜用或切片晒干。性味:苦、辛,温。功能主治:祛风除湿,消肿止痛。用于风湿痛,头风痛,胸胁痛,腹泻痛;外用治跌打损伤,瘀血肿痛。
黄姜,学名盾叶薯蓣,俗名火藤根、粉黄姜,属薯蓣科,为薯蓣科植物盾叶薯蓣DioscoreazingiberensisC.H.Wright的根茎。其有效成份是根状茎内含丰富的皂甙配基(即皂素),是合成甾体激素类药物的起始原料。中医学认为其性味甘﹑苦﹑凉 ,具有清肺止咳,利湿通淋,通络止痛,解毒消肿的功能,可治肺热咳嗽,湿热淋痛,风湿腰痛,痈肿恶疮,跌打扭伤,蜂蜇虫咬,同时具有治疗皮肤急性化脓性感染、软组织损伤、降血脂等功效,也有降低胆固醇、抗炎、抗肿瘤等药理作用。
了刁竹,中药名。为萝藦科牛皮消属植物徐长卿Cynanchumpaniculatum(Bge.)Kitag.的干燥根及根茎。秋季采挖,除去杂质,阴干。辛,温。归肝、肺经。功能:祛风,化湿,止痛,止痒。主治:用于治疗风湿痹痛,胃痛胀满,牙痛,跌扑伤痛,风疹、湿疹。外用治痈肿,毒蛇咬伤。
山胡椒,学名:Lindera glauca (Sieb. et Zucc.) Bl,为樟科植物牛筋树的果实,秋季果熟时采取。性味:辛,温。功能主治:祛风活络、解毒消肿、止血止痛。用于治疗:劳伤、筋骨酸麻、食纳欠佳、肢体肿胀、痛肿初起、红肿焮痛、风湿麻痹、风热感冒、中风不语。药理作用:抗病原微生物作用 体外试验山胡椒挥发油对常见的14种革兰阳性和阴性细菌均有不同程度的抗菌作用,其中对卡他奈球菌、乙型链球菌、肺炎链球菌等的抗菌作用最强(抗菌效价在1:1000以上)。此外,该挥发油对新型隐球菌和白色念珠菌两种真菌也表现明显的抑菌作用。
棉花籽,即:棉花子,药材基源:为锦葵科植物草棉Gossypium herbaceum L.陆地棉G.hirsutum L.,海岛棉G.barbadense L.和棉G.arboreum L.的种子。秋季采收棉花时,收集种子,晒干。性味:辛;性热;归经肾;脾;女子胞经;功能主治:温肾;通乳;活血止血。主阳痿;腰膝冷痛;白带;贵尿;胃痛;乳汁不通;崩漏;痔血。
松香,中药材,为松科植物马尾松Pinus massoniana Lamb.、油松Pinustabulaeformis Carr.或同属数种植物的树脂除去挥发油后,所留存的固体树脂。多在夏季采收,在松树干上用刀挖成V字形或螺旋纹槽,使边材部的油树脂自伤口流出,收集后,加水蒸馏,使松节油馏出,剩下的残渣,冷却凝固后,即为松香。置阴凉干燥处,防火、防热。性味苦、甘、温。有小毒。功能主治:祛风燥湿,生肌止痛,适用于痈疖疮疡,湿疹,外伤出血,烧烫伤。
冰片,其他名称:龙脑、龙脑香、脑子、冰片、片脑、冰片脑、梅花脑、天然冰片、老梅片、梅片。主要成分:本品为从龙脑香科植物龙脑香 (拉丁学名:Dipterocarpus turbinatus Gaertn.f.)的树脂和挥发油中取得的结晶,是近乎纯粹的右旋龙脑。性味:辛苦,凉。归经:入心、肺经。功能主治:通诸窍,散郁火,去翳明目,消肿止痛。治中风口噤,热病神昏,惊痫痰迷,气闭耳聋,喉痹,口疮,中耳炎,痈肿,痔疮,目亦翳膜,蛲虫病。
透骨消,别名大透骨消、满山香、透骨草、岩子果、香叶子、炸山叶、冬青叶;药材基源:为杜鹃花科植物地檀香的根、叶、果实或全株。拉丁植物动物矿物名:Gaultheriaforrestii Diels,秋季采根切片,夏季采叶,秋季采果实,晒干。性味苦;辛;性温归经心,脾经,功能主治:祛风湿;通经络;健脾利水。主风湿痹证;四肢瘫痪;水肿;小儿疳积。
铜钻,别名:假丁公藤、甜果藤、黄九牛,为茶茱萸科植物定心藤Mappianthusiodoides Hand-Mazz根、茎。冬季采收,挖取根部或割下藤茎,切片,晒干。性味苦,凉。祛风活络,消肿,解毒。功能主治:活血调经;祛风除湿。主月经不调;痛经;闭经;产后腹痛;手足麻痹,跌打损伤;外伤出血;风湿痹痛;腰膝酸痛。
小钻,中药材,又称作“红木香”;也有地区称作:香藤根,钻骨风,紫金皮,紧骨香,木腊,小血藤等,中药红木香为五味子科植物长梗南五味子的根或根皮。拉丁植物动物矿物名:Kadsura longipedunculata Finet et Gagn.[K.peltigera Rehd.Et Wils.]立冬前后采挖,去净残茎,细根及泥土,晒干。或剥取根皮,晒干。药理作用:镇痛,对消化道炎症,溃疡性疼痛,有明显的止痛效果;止吐,红木香对急性胃肠炎的呕吐,神经性呃逆,均有作用。性味与归经:辛;苦;性温;归脾;胃;肝经。功效与作用:理气止痛;活血消肿;祛民通络。主治胃痛;腹痛;风湿痹痛;痛经;月经不调;无名肿毒;跌打损伤伤;产后腹痛;咽喉肿痛;痔疮。
四方藤,葡萄科白粉藤属植物四方藤Cissus pteroclada Hayata,以藤入药。全年可采,晒干。性味:微酸、涩,平。功能主治:祛风湿,舒经络。用于风湿痹痛,关节胀痛,腰肌劳损,筋络拘急。用法用量:内服:煎汤,10-30g;或浸酒。外用:适量,捣烂敷;或泡酒搽。《陆川本草》:去风湿。治四肢挛急,抽搐,风湿痛,跌打伤筋。《广西中药志》:舒筋活络,去瘀生新。治跌打内伤,筋络拘挛。
黄花倒水莲,中药名,远志科植物黄花倒水莲Polygala aureocauda Dunn.的根。夏、秋季采收,挖取根部,洗净,晒干。性味归经】性平,味甘、微苦。归肝经、肾经、脾经。有补益气血,健脾利湿,活血调经之功能。功能主治:补益,强壮,祛湿,散瘀。治虚弱虚肿,急慢性肝炎,腰腿酸疼,跌打损伤。用于病后体虚,腰膝酸痛,跌打损伤,黄疸型肝炎,肾炎水肿,子宫脱垂,白带,月经不调。《广西药植名录》:全株:舒筋活络,治黄疸,血崩,月经不调,子宫脱垂,产妇虚弱。根:祛风,去湿,止痛。
白芷,中药名。为伞形科当归属植物白芷Angelica dahurica(Fisch.ex Hoffm)Benth.et Hook.f.和杭白芷Angelica dahurica(Fisch ex Hoffm.)Benth.etHook.f.var.formosana(Boiss.)Shan et Yuan的根。秋间叶黄时采挖,除去须根及泥沙,晒干或低温干燥。性味:性温,味辛,气芳香,微苦。具有解表散寒,祛风止痛,通鼻窍,燥湿止带,消肿排脓,祛风止痒的功效。主治风寒感冒,头痛、牙痛、痹痛等多种疼痛,鼻渊,带下证,疮痈肿毒,皮肤风湿瘙痒等。
枫荷桂,别名檫树、独脚樟、天鹅枫等,来源为樟科檫木属植物檫树Sassafrastzamu Hemsl. [Pseudosassafras tzamu Lecomte; P. laxiflora (Hemsl.) Nakai],以根、树皮及叶入药。秋后采集,晒干。性味甘、淡,温。功能主治:祛风逐湿,活血散瘀。用于风湿性关节炎,类风湿关节炎,腰肌劳损,慢性腰腿痛,半身不遂,跌打损伤,扭挫伤;外用治刀上出血。枫荷桂具有舒筋活络,降暑下火的,跌打损伤,化瘀的作用。
威灵仙,为毛茛科植物威灵仙Clematis chinensis Osbeck 、棉团铁线莲(山蓼)Clematis hexapetala Pall.或东北铁线莲(黑薇)Clematis manshurica Rupr.的干燥根及根茎。秋季采挖,除去泥沙,晒干。性味:辛、咸,温。归经:归膀胱经。该种根及茎入药具有祛风湿、通经络、消骨梗之功效。在现代临床实践中其新的用途不断的被发现,如治疗胆结石,跟骨骨刺、足跟痛、食管癌等。功能主治:祛风除湿,通络止痛。用于风湿痹痛,肢体麻木,筋脉拘挛,屈伸不利,骨哽咽喉。
本发明技术方案所用的药物组成中,透骨消,铜钻,小钻,四方藤,威灵仙和枫荷桂,祛风除湿、舒筋活络、活血散瘀、通络止痛,桂枝和白芷,解表散寒、祛风止痛、发汗解肌、温通经脉;配以蓝姜,黄姜,了刁竹和山胡椒,祛风除湿、清肺止咳、通络止痛、解毒消肿;棉花籽和黄花倒水莲,温肾、补益、祛湿、活血散瘀;松香,冰片和赤芍,祛风燥湿、生肌止痛、通诸窍、散郁火、散瘀止痛;诸药合用共奏祛风除湿,温通经络,活血止痛之功。本发明综合起来利用了各味药的祛风除湿、通络止痛、活血化瘀、舒筋活络、祛风散寒、解毒消肿、温经活络等功效,制备得到的外用药膜涂膜剂疗效好、安全性高,对人体无毒副作用,对于风湿痹痛,关节僵硬,屈伸不利,关节疼痛、肢体麻木等都有很好的治疗效果。
本发明制备的一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂制备工艺简单,不需要特殊设备;使用时涂于患处,形成药膜保护创面,且耐磨性能好,不易脱落;不需包扎,容易清洗不污染衣物,不需裱背材料,使用方便;膜的形成减少了皮肤表面水分的蒸发,促进了水合作用和溶解角质作用,使药物透过角质层逐渐释放药物,更好的发挥治疗作用。
本发明的有益效果为:
1、原料来源广,成本低。本发明制备的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂以中草药原料作为主要原料,配方合理,原料来源广,用药安全,而且制备工艺简单,不需要特殊设备,成本低,疗效显著,适合工业化大生产,具有广阔的应用前景。
2、本发明一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂采用桂枝、赤芍、蓝姜、黄姜、了刁竹、山胡椒、棉花籽、松香、冰片、透骨消、铜钻、小钻、四方藤、黄花倒水莲、白芷、风荷桂和威灵仙为原料制备而成,所用的各原料是发明人通过对苗药进行考察和探索,经过反复的配伍和大量的实验研究后从苗族传统药物中筛选出来的,处方配伍得当、严谨。该涂膜剂的镇痛、抗炎、对扭伤的保护、治疗等药理作用强。
3、本发明通过各种中草药原料的配伍作用,综合起来利用了各味药的祛风除湿、通络止痛、活血化瘀、舒筋活络、祛风散寒、解毒消肿、温经活络等功效,制备得到的外用药膜涂膜剂具有祛风除湿,温通经络,活血止痛的功效,对于风湿、类风湿、痛风等症有很好的治疗效果,对风湿痹痛,关节疼痛,肢体麻木,关节僵硬,屈伸不利以及风、寒、湿、痰、淤等引起的各种疼痛具有缓解及促进康复的保健作用;见效快、疗效好且安全性高,对人体无毒副作用。
4、本发明运用传统中药内病外治的方法和现代药学透皮吸收理论,生物利用度高,皮肤吸收快,本发明制备得到的外用药膜涂膜剂可直接贴敷于体表任何部位,通过皮肤渗透能直达病变部位、不经过肝脏的首过效应,对胃肠道无任何刺激、而且避免了消化酶类对药物的破坏作用,涂抹到皮肤上达到祛风活血、促进血管扩张、促进汗腺分泌、使机体散热增加、促使血液循环、疏通经络、活血化瘀、解表散寒,从而激活细胞活性的作用。
附图说明
图1为本发明实施例3制备得到的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂成品图。
具体实施方式
实施例1
一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂,包括以下重量份数的原料:桂枝10份;赤芍10份;蓝姜10份;黄姜10份;了刁竹10份;山胡椒10份;棉花籽40份;松香5份;冰片5份;透骨消10份;铜钻20份;小钻20份;四方藤20份;黄花倒水莲10份;白芷10份;风荷桂10份和威灵仙10份。足量的纯化水,足量的体积浓度为50-70%的乙醇溶液和足量的体积浓度为85%-95%的乙醇溶液。
所述的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂的制备方法,具体制备步骤如下:
(1)中药浸膏的制备:将各原药材分别除杂、干燥,然后粉碎成粗粉,过40目筛,按上述配方重量份数量取各原料混合,用原料药质量6倍、体积浓度70%的乙醇溶液浸渍2次,每次3天,合并浸渍液,过滤,滤液浓缩为60℃时相对密度为1.15-1.20的浸膏;
(2)成膜剂的准备:取50g 聚乙烯醇(PVA-1788),加入适量体积浓度为85%的乙醇溶液浸泡14 h后,烘干,加适量纯化水在水浴上加热溶解,然后再加入35ml甘油,搅拌均匀,制得成膜剂;
(3)成品的制备:以重量份数计,取步骤(2) 制备得到的成膜剂3份,向其加入步骤(1) 制备的中药浸膏2份,同时加入羧甲基淀粉钠0.75份、氮酮0.35份、明胶0.75份、高岭土0.15份和二氧化钛0.2份,室温下搅拌机转速为50r/min搅拌30分钟,即得。
实施例2
一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂,包括以下重量份数的原料:桂枝35份;赤芍37份;蓝姜36份;黄姜35份;了刁竹36份;山胡椒37份;棉花籽75份;松香15份;冰片10份;透骨消30份;铜钻42份;小钻43份;四方藤42份;黄花倒水莲30份;白芷20份;风荷桂40份和威灵仙20份以及足量的纯化水,足量的体积浓度为50-70%的乙醇溶液和足量的体积浓度为85%-95%的乙醇溶液。
所述的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂的制备方法,具体制备步骤如下:
(1)中药浸膏的制备:将各原药材分别除杂、干燥,然后粉碎成粗粉,过40目筛,按配方重量份数量取各原料混合,用原料药质量7倍、体积浓度60%的乙醇溶液浸渍3次,每次2.5天,合并浸渍液,过滤,滤液浓缩为60℃时相对密度为1.15-1.20的浸膏;
(2)成膜剂的准备:取50g 聚乙烯醇(PVA-1788),加入适量体积浓度为85%的乙醇溶液浸泡12h后,烘干,加适量纯化水在水浴上加热溶解,然后再加入35ml甘油,搅拌均匀,制得成膜剂;
(3)成品的制备:以重量份数计,取步骤(2) 制备得到的成膜剂4份,向其加入步骤(1) 制备的中药浸膏3份,同时加入羧甲基淀粉钠1份、氮酮0.5份、明胶1份、高岭土0.2份和二氧化钛0.3份,室温下搅拌机转速为50r/min搅拌33分钟,即得。
实施例3
一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂,包括以下重量份数的原料:桂枝20份;赤芍20份;蓝姜20份;黄姜20份;了刁竹15份;山胡椒20份;棉花籽60份;松香10份;冰片8份;透骨消20份;铜钻30份;小钻30份;四方藤30份;黄花倒水莲20份;白芷15份;风荷桂20份;威灵仙15份以及足量的纯化水,足量的体积浓度为50-70%的乙醇溶液和足量的体积浓度为85%-95%的乙醇溶液。
所述的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂的制备方法,具体制备步骤如下:
(1)中药浸膏的制备:将各原药材分别除杂、干燥,然后粉碎成粗粉,过40目筛,按配方重量份数量取各原料混合,用原料药质量8倍、体积浓度50%的乙醇溶液浸渍4次,每次2天,合并浸渍液,过滤,滤液浓缩为60℃时相对密度为1.15-1.20的浸膏;
(2)成膜剂的准备:取50g 聚乙烯醇(PVA-1788),加入适量体积浓度为95%的乙醇溶液浸泡13h后,烘干,加适量纯化水在水浴上加热溶解,然后再加入35ml甘油,搅拌均匀,制得成膜剂;
(3)成品的制备:以重量份数计,取步骤(2) 制备得到的成膜剂5份,向其加入步骤(1) 制备的中药浸膏4份,同时加入羧甲基淀粉钠1.25份、氮酮0.65份、明胶1.25份、高岭土0.25份和二氧化钛0.4份,室温下搅拌机转速为50r/min搅拌35分钟,即得。
实施例4
一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂,包括以下重量份数的原料:桂枝40份;赤芍40份;蓝姜40份;黄姜40份;了刁竹25份;山胡椒40份;棉花籽80份;松香15份;冰片12份;透骨消40份;铜钻50份;小钻50份;四方藤50份;黄花倒水莲40份;白芷25份;风荷桂40份;威灵仙25份以及足量的纯化水,足量的体积浓度为50-70%的乙醇溶液和足量的体积浓度为85%-95%的乙醇溶液。
所述的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂的制备方法,具体制备步骤如下:
(1)中药浸膏的制备:将各原药材分别除杂、干燥,然后粉碎成粗粉,过40目筛,按配方重量份数量取各原料混合,用原料药质量7倍、体积浓度70%的乙醇溶液浸渍3次,每次2天,合并浸渍液,过滤,滤液浓缩为60℃时相对密度为1.15-1.20的浸膏;
(2)成膜剂的准备:取50g 聚乙烯醇(PVA-1788),加入适量体积浓度为90%的乙醇溶液浸泡12h后,烘干,加适量纯化水在水浴上加热溶解,然后再加入35ml甘油,搅拌均匀,制得成膜剂;
(3)成品的制备:以重量份数计,取步骤(2) 制备得到的成膜剂4份,向其加入步骤(1) 制备的中药浸膏3.2份,同时加入羧甲基淀粉钠1.1份、氮酮0.55份、明胶1.2份、高岭土0.23份和二氧化钛0.3份,室温下搅拌机转速为50r/min搅拌30分钟,即得。
实施例5
一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂,包括以下重量份数的原料:桂枝50份;赤芍50份;蓝姜50份;黄姜50份;了刁竹30份;山胡椒50份;棉花籽100份;松香20份;冰片15份;透骨消50份;铜钻60份;小钻60份;四方藤60份;黄花倒水莲50份;白芷30份;风荷桂50份和威灵仙30份以及足量的纯化水,足量的体积浓度为50-70%的乙醇溶液和足量的体积浓度为85%-95%的乙醇溶液。
所述的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂的制备方法,具体制备步骤如下:
(1)中药浸膏的制备:将各原药材分别除杂、干燥,然后粉碎成粗粉,过40目筛,按配方重量份数量取各原料混合,用原料药质量6倍、体积浓度70%的乙醇溶液浸渍4次,每次2天,合并浸渍液,过滤,滤液浓缩为60℃时相对密度为1.15-1.20的浸膏;
(2)成膜剂的准备:取50g 聚乙烯醇(PVA-1788),加入适量体积浓度为85%的乙醇溶液浸泡13 h后,烘干,加适量纯化水在水浴上加热溶解,然后再加入35ml甘油,搅拌均匀,制得成膜剂;
(3)成品的制备:以重量份数计,取步骤(2) 制备得到的成膜剂5份,向其加入步骤(1) 制备的中药浸膏4份,同时加入羧甲基淀粉钠1份、氮酮0.6份、明胶1.25份、高岭土0.2份和二氧化钛0.35份,室温下搅拌机转速为50r/min搅拌35分钟,即得。
药效学试验资料:
一、为验证本发明制备得到的外用药膜涂膜剂的祛风除湿、温通经络、活血止痛的实际功效,发明人对其药效学进行了初步研究。本品药理作用作为参考依据。具体如下:
1.实验材料
1.1实验动物
SPF级小鼠,体重18~22g,由广西中医药大学药学院药理室提供。
1.2实验仪器、试剂
YLS-6B型智能热板仪(北京基因科技有限公司),XS205DU电子分析天平(瑞典METTLER公司);冰醋酸,广东光华科技股份有限公司,批号:20190829 ,二甲苯,天津市大茂化学试剂厂,批号20170601,双氯芬酸钠凝胶(武汉马应龙药业股份有限公司,批号190702),
2.受试物剂量及给药途径设计
采用本发明实施例2中制备得到的外用药膜涂膜剂产品。根据处方计算,每日使用量为 10g,为一份含膏样品(实际含膏量为 3g)。按照中国成年男女平均体重50kg计,将给药剂量设低高两档,分别为成人日摄入量的5倍、10倍,计算数值为1、2g/kgbw·d,分别取0.02、0.04g含膏样品作为小鼠给药低、高剂量组(含膏剂量为0.3g/kg、0.6g/kg);同时制备空白对照组(取除药材提取浸膏之外的其余制剂辅料,按制备工艺进行制剂,即得。);阳性药组(双氯芬酸钠凝胶,规格15g:0.15g,取0.6g双氯芬酸钠凝胶作为小鼠阳性药组给药剂量,含双氯芬酸钠为0.3g/kg)。在试验前24小时于小鼠腹部相同部位脱毛,脱毛面积约4cm²(2cm×2cm)。
3.镇痛活性研究
本研究采用热板法、醋酸扭体法来评价本发明外用药膜涂膜剂对小鼠热刺激性疼痛、化学刺激性疼痛反应的影响。
3.1热板法
取SPF雌性小鼠40只,体重20±2g。热板温度控制在55℃,室温20±1℃,置小鼠于热板上,测定小鼠自放在热板上至出现添后足或者跳离热板所需的时间(s),凡添足时间小于5秒或大于30秒者弃之不用。将合格的小鼠随机分为组:空白组(空白对照组、阳性药组(双氯芬酸钠凝胶剂)、涂膜剂低剂量组、涂膜剂高剂量组,每组10只。给药前,测定各组小鼠反应时间(s),按表1项下剂量给予试药,涂抹在小鼠脱毛区域,分别于给药后0.5h,1h,1.5h测定小鼠的反应时间。若60秒仍无反应,将小鼠取出。以免烫伤,其痛阈值以60秒计算。结果见表1。
痛阈提高百分率=(用药后平均反应时间一用药前平均反应时间)/用药前平均反应时间×100%。
阳性药组在给药后30 min痛阈值最高,提示造模成功。涂膜剂低、高剂量组在给药后60min痛阈值最高,痛阈提高百分率达到61.56% (P<0.01),比阳性药组有更好的镇痛活性。此外在30min和90min时间点也有较明显的镇痛活性,高低剂量组的镇痛活性相当。
3.2醋酸扭体法
取SPF雄性小鼠40只,体重20±2g。小鼠随机分为组:空白组(空白对照组、阳性药组(双氯芬酸钠凝胶剂)、涂膜剂低剂量组、涂膜剂高剂量组,每组10只。按表2项下剂量给予试药,涂抹在小鼠脱毛区域,给药30min后,腹腔注射%冰醋酸溶液0.02ml/g,然后观察透明塑料笼的小鼠在20min内的扭体次数。结果见表2。
抑制率(%)=(空白组平均次数-给药组平均次数)/空白组平均次数×100%
结果表明,阳性药组对醋酸所致的化学疼痛有明显的抑制作用,明显减少扭体次数。涂膜剂高剂量组镇痛活性高于低剂量组,与空白组均有显著性差异,与阳性药组无显著性差异。
4 抗炎活性研究
本研究选用二甲苯致小鼠耳肿胀模型来评价外用药膜涂膜剂的抗炎活性。二甲苯致小鼠耳肿胀属于以血管及其通透性为主要改变的急性炎症模型,即第一炎症时相动物模型。
取SPF雄性小鼠40只,体重20±2g。小鼠随机分为组:空白组(空白对照组、阳性药组(双氯芬酸钠凝胶剂)、涂膜剂低剂量组、涂膜剂高剂量组,每组10只。在每只小鼠右耳前后两面分别涂抹二甲苯50μl,30min后按0.3g/kg剂量给予试药,以同法涂于右耳耳壳,左耳不涂作为空白对照,于给药30min后,迅速脱颈椎将小鼠处死,沿耳廓剪下两耳,用直径6 mm打孔器在其中央位置打下耳片,立即称定湿重(mg),左右耳片的重量差为肿胀度,并计算给药组的肿胀抑制率。结果见表3。
耳肿胀度=右耳重-左耳重;
抑肿率=(空白组平均耳肿胀度-给药组平均耳肿胀度)/空白组平均耳肿胀度。
阳性对照组能明显抑制小鼠的耳肿胀,与空白组比较有显著性差异(P<O.Ol)。涂膜剂低剂量组也能明显抑制小鼠的急性炎症,抑肿率有49.22%,涂膜剂高剂量组接近阳性药,表明有显著的抗炎效果。
5 讨论
热板法、醋酸扭体法均是经典的筛选镇痛药的实验,抗炎实验采用经典的二甲苯致小鼠耳肿胀模型,实验结果表明涂膜剂低剂量组镇痛作用优于阳性药组,对二甲苯诱导的小鼠耳廓肿胀有明显改善,可能与复方中多种药材具有祛风、温络、止痛的功效有关。上述实验表明:本发明制备得到的外用药膜涂膜剂产品的镇痛、抗炎、对扭伤的保护、治疗等药理作用强,祛风除湿、温通经络、活血止痛的的实际功效好,可用于治疗风湿病、痛风或风、寒、湿、痰、淤等引起的各种疼痛。
二、一般资料:
下表4为近10年来采用本发明的外用药膜涂膜剂产品进行治疗各种痛症(包括腰肌劳损、筋膜炎、风湿性关节炎、痛风、增生性骨关节炎、腰间椎盘突出症、肩周炎、风湿痹痛,关节疼痛等痛症)的患者人数及其治愈率数据统计表。患者均系门诊病人,疗效治愈标准为:各种痛症相应的症状基本消失,功能活动基本恢复正常。
从上表4中可见,采用本发明的外用药膜涂膜剂产品进行治疗各种痛症,治疗效果好,治愈率高。
三、临床效果 (典型病例):
1、王某,男,56岁,反复腰部疼痛10余年,行腰椎磁共振检查提示L4-5椎间盘突出,诊断为腰椎间盘突出症,用本发明外用药膜涂膜剂产品加热外敷痛处,每次60分钟,3-5次后疼痛明显缓解,配合拔罐、针灸疗效更佳。
2、汪某,男,45岁,反复双侧膝关节疼痛5年余,行双侧膝关节磁共振提示:双侧盘状外侧半月板、右膝内侧半月板后角及左膝外侧半月板后角撕裂;双膝关节少量积液。用本发明外用药膜涂膜剂产品加热外敷痛处,每次60分钟,配合针灸治疗,4次治疗后疼痛明显缓解。
3、罗某,男,66岁,反复颈肩背疼痛8年,伴头晕头痛,颈椎X线片检查提示:颈椎生理曲度变直,C4-5椎间隙狭窄,骨刺增生,项韧带钙化。臂丛神经牵拉试验(+),椎间孔压缩试验(+),头顶叩击试验(+)。诊断为神经根型颈椎病,用本发明外用药膜涂膜剂产品加热外涂于痛处,每次60分钟,3-5次后疼痛明显缓解,配合拔罐、针灸疗效更佳。
4、李某,女,34岁,右侧膝关节疼痛1月余,辅查右膝关节X片提示骨质形态及密度未见改变,关节面光滑,关节间隙变窄,诊断为右膝关节炎,用本发明外用药膜涂膜剂产品外涂于痛处,每次60分钟,配合针灸治疗,1次治疗后疼痛明显缓解。
Claims (3)
1.一种祛风除湿、温通经络、活血止痛的外用药膜涂膜剂,其特征在于,包括以下重量份数的中药材原料:桂枝10-50份;赤芍10-50份;蓝姜10-50份;黄姜10-50份;了刁竹10-30份;山胡椒10-50份;棉花籽40-100份;松香5-20份;冰片5-15份;透骨消10-50份;铜钻20-60份;小钻20-60份;四方藤20-60份;黄花倒水莲10-50份;白芷10-30份;风荷桂10-50份和威灵仙10-30份。
2.根据权利要求1所述的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂,其特征在于,包括以下重量份数的原料:桂枝20-40份;赤芍20-40份;蓝姜20-40份;黄姜20-40份;了刁竹15-25份;山胡椒20-40份;棉花籽60-80份;松香10-15份;冰片8-12份;透骨消20-40份;铜钻30-50份;小钻30-50份;四方藤30-50份;黄花倒水莲20-40份;白芷15-25份;风荷桂20-40份;威灵仙15-25份以及足量的纯化水,足量的体积浓度为50-70%的乙醇溶液和足量的体积浓度为85%-95%的乙醇溶液。
3.如权利要求1或2所述的祛风除湿、温通经络、活血止痛的外用药膜涂膜剂的制备方法,其特征在于,具体制备步骤如下:
(1)中药浸膏的制备:分别将除杂、干燥后的各中药材原料粉碎成粗粉,过40目筛,按配方重量份数,量取各中药原料混合,用原料药质量6-8倍、体积浓度为50-70%的乙醇溶液浸渍2-4次,每次2-3天,合并浸渍液,过滤,滤液浓缩为60℃时相对密度为1.15-1.20的浸膏;
(2)成膜剂的准备:取50g 聚乙烯醇,加入适量体积浓度为85%-95%的乙醇溶液浸泡12-14 h后,烘干,加适量纯化水在水浴上加热溶解,然后再加入35ml甘油,搅拌均匀,制得成膜剂;
(3)成品的制备:以重量份数计,取步骤(2) 制备得到的成膜剂3-5份,向其加入步骤(1) 制备的中药浸膏2-4份,同时加入羧甲基淀粉钠0.75-1.25份、氮酮0.35-0.65份、明胶0.75-1.25份、高岭土0.15-0.25份和二氧化钛0.2-0.4份,室温下搅拌机转速为50r/min搅拌30-35分钟,即得。
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