CN111558004A - 一种治疗疮疡及无名肿毒的中药复方制剂及其制备方法和应用 - Google Patents
一种治疗疮疡及无名肿毒的中药复方制剂及其制备方法和应用 Download PDFInfo
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Abstract
本发明涉及中医药领域,具体是一种治疗疮疡及无名肿毒的中药组合物,由白杨树穗、虎耳草、透骨草、鲜紫花地丁、鲜黄花地丁、金银花、山慈菇、草河车、鲜商路、没药、乳香、血竭、儿茶、三七、冰片、广丹组成。本发明还提供一种治疗疮疡及无名肿毒的中药复方制剂及其制备方法和应用。本发明主治各种乳癖、乳痈、疮疡痈节、无名肿毒、瘿病、瘰疬、流痰、皮肤顽癣以及跌打损伤而引起瘀血肿痛者。对于疮疡初期具有消肿止痛;成脓期提脓拔毒;破溃期去腐生肌、保护创面的作用。
Description
技术领域
本发明涉及中医药领域,具体地说,是一种治疗疮疡及无名肿毒的中药复方制剂及其制备方法和应用。
背景技术
疮疡、无名肿毒又名肿疡、痈疮、虚疡,是各种致病因素侵袭人体后引起的皮肉筋骨间发生的化脓性疾病,包括急性和慢性两大类。
急性疮疡初起时,患处皮肤红肿明显,质软无头,疼痛剧烈。但很快结块,呈一片稍隆起的紫红色浸润区,质地坚韧,界线不清。此时轻者无全身症状,重者可有发热恶寒,头痛恶心等。当化脓时,局部肿势高突,中央可有多个脓栓,局部按之中软。全身发热持续不退,破溃后流出黄色质稠脓液,溃烂成蜂窝状;疮疡还极易向四周深部发展,周围水肿明显,引起局部淋巴结肿大。包括现代医学中疖、痈、皮肤浅表脓肿、急性化脓性淋巴结炎、急性蜂窝组织炎、化脓性骨髓炎、化脓性关节炎、急性腮腺炎、丹毒、毛囊炎、乳腺炎等常见的化脓性感染性疾病。
目前,对于上述疾病的治疗西医多采用抗生素联合激素治疗,以口服药或者静脉注射方式给药,虽然卓有成效,然停药后极易复发,且容易转为慢性,导致迁延不愈。至于外用药,多为红霉素、金霉素类非常局限的抗生素类药膏,但也作用有限,疗效欠佳。
中医认为,疮疡及各种无名肿毒的致病因素分为外感和内伤两大类。外感多因六淫邪毒、感受特殊之毒、外来伤害等引发,内伤者多因饮食失律,情志失调等导致脾胃失和,厥阴之气失于疏泄,郁久化热,热胜肉腐,虚实寒热凝结,以致正虚邪恋而成。《诸病源候论》卷五十有:“热气乘之,热胜于寒,则血肉腐败,化为脓,脓溃之后,其疮不瘥。”《外科大成》卷四则谓:“无名肿毒者,以其随处而生,不按穴位,不可以命名也。皆因风邪寒热客于经络所致者。若因风邪内作而引起者则无头无根;若因气血相搏者,则有头有根;因风寒而成者,则肿坚色白;因热毒而成者,则肿焮而色赤。”外邪引发的疮疡,以火毒、热毒最为常见。内伤引起的疮疡,大多因虚致病,且慢性者居多,较外邪引起者严重。
对于这类疾病的治疗,中医遵从:有表证者散之,有里证者下之,外治参之以敷贴之剂。在治疗上选用疏散风热,活血化瘀,消肿止痛,解毒通腑,表里两清之药。因该类疾病多为体表疾病,所以中医的外用药以其作用直接、疗效显著而占独特优势。对于轻浅的疮疡,单用中医外用药即可治愈,对于严重的病症,在外用药的同时配合中药内服,必要时辅以西医治疗,可取良效。所以针对该类疾病,中医的外用药贯穿疾病治疗始终,必须加以挖掘和发扬。
发明内容
本发明的目的在于提供一种治疗疮疡及无名肿毒的中药组合物(以下简称“赵氏一笔消”),及以该中药组合物作为活性成份的中药复方制剂,本发明的另一目的是提供该中药复方制剂的制备方法,本发明的第三目的是提供该中药组合物和复方制剂的应用。
本发明的第一方面,提供一种治疗疮疡及无名肿毒的中药组合物,由如下重量份的原料药组成:
白杨树穗100-400份、虎耳草25-75份,透骨草25-75份、鲜紫花地丁25-75份、鲜黄花地丁25-75份、金银花25-75份、山慈菇25-75份、草河车25-75份、鲜商路25-75份、没药9-21份、乳香9-21份、血竭9-21份、儿茶9-21份、三七9-21份、冰片5-15份、广丹0.5-1.5份。
优选的,所述的治疗疮疡及无名肿毒的中药组合物,由如下重量份的原料药组成:
白杨树穗250份,虎耳草50份,透骨草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、没药15份、乳香15份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份。
本发明的疮疡及无名肿毒的中药组合物由白杨树穗、虎耳草、透骨草、鲜紫花地丁、鲜黄花地丁、金银花、山慈菇、草河车、鲜商路、没药、乳香、血竭、儿茶、三七、冰片、广丹16味中药组成。方中白杨树穗,需秋分后采集,色黑、味苦咸涩,入心脾肺肾之经,具有清热解毒、散结消肿、清宣肺气、健脾化湿的作用,为方中君药;虎耳草、透骨草二味引药入于皮内,有搜风解毒、活血止痛、祛风除湿之功,为臣药;佐以鲜紫花地丁、鲜黄花地丁、金银花、山慈菇、草河车、鲜商路、冰片、广丹,清热解毒、化痰软坚、消肿散结、透邪止痛;没药、乳香、儿茶、血竭、三七活血化瘀、消肿止痛、生肌敛疮为使药。用于各种疮疡、乳癖、疖肿、无名肿毒、痰核流注、瘰疬。
本发明的第二方面,提供一种治疗疮疡及无名肿毒的中药复方制剂,所述的治疗疮疡及无名肿毒的中药复方制剂以如上所述的中药组合物作为活性成分。
优选的,所述的治疗疮疡及无名肿毒的中药复方制剂的剂型为外用涂膜剂。其优点为能在涂抹处迅速形成药物膜,达到持续治疗的作用。用法:将药膏涂于患处,厚度约1-3mm。疮肿有形时,涂于疮周留出疮肿中心,以备收敛,如疮疡平塌漫肿,涂于疮面上,以备消散。
本发明的第三方面,提供一种如上所述的治疗疮疡及无名肿毒的中药复方制剂的制备方法,包括以下步骤:
取透骨草、乳香、没药,蒸馏,收集蒸馏液,分离挥发油,药渣加水提,过滤提取液,备用;取白杨树穗、虎耳草、鲜紫花地丁、鲜黄花地丁、金银花、山慈菇、草河车、鲜商路、血竭、儿茶、三七、冰片、广丹,水提后与蒸馏药渣提取液合并浓缩,干燥,得提取物;聚乙烯醇PVA-124,西黄蓍胶,用乙醇溶胀后,加入提取物,蒸馏液,羧甲基纤维素(CMC)和纯化水,加至200mL,加热,搅拌均匀,即得。
本发明通过考察浸渍、加水量和蒸馏时间对挥发油量的影响;通过考察水提法、乙酸提取法和乙醇回流法对一笔消提取物的得膏率的影响;通过正交设计法考察加水量、提取时间和提取次数对一笔消提取物中绿原酸含量、得膏率的影响;通过正交设计考察聚乙烯醇PVA-124的用量、乙醇浓度、西黄蓍胶的用量、羧甲基纤维素(CMC)的用量对成膜时间、黏度、成膜质量的影响,对“赵氏一笔消”涂膜剂的制备工艺进行优化。结论:
通过上述试验方法筛选出本发明的中药复方制剂的最佳制备工艺为:取透骨草50份、乳香15份、没药15份,加8倍量,蒸馏6小时,收集蒸馏液,分离挥发油约5mL,药渣加12倍量水,提取2次,每次2小时,过滤提取液,备用;取白杨树穗250份、虎耳草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份,加12倍量水,提取2次,每次2小时,过滤提取液,与蒸馏药渣提取液合并浓缩至每mL浸膏相当于中药材5g,干燥,得提取物约90g;聚乙烯醇PVA-124(安徽山河辅料有限公司,20180603)40g,西黄蓍胶(安徽山河辅料有限公司,20170907)10g用40%乙醇50mL溶胀后,加入一笔消提取物、挥发油、羧甲基纤维素(CMC)(安徽山河辅料有限公司,20180301)8g,纯化水加至200mL,加热,搅拌均匀,即得。综合评定结果最佳三批中试样品质量稳定,适合作为本发明的中药组合物的提取工艺。
本发明的第四方面,提供一种如上所述的治疗疮疡及无名肿毒的中药组合物在制备治疗乳癖、乳痈、疮疡痈节、无名肿毒、瘿病、瘰疬、流痰、皮肤顽癣的药物中的应用。
本发明的第五方面,提供一种如上所述的治疗疮疡及无名肿毒的中药复方制剂在制备治疗乳癖、乳痈、疮疡痈节、无名肿毒、瘿病、瘰疬、流痰、皮肤顽癣的药物中的应用。
本发明优点在于:
1、本发明的疮疡及无名肿毒的中药组合物白杨树穗、虎耳草、透骨草、鲜紫花地丁、鲜黄花地丁、金银花、山慈菇、草河车、鲜商路、没药、乳香、血竭、儿茶、三七、冰片、广丹16味中药组成。方中白杨树穗,需秋分后采集,色黑、味苦咸涩,入心脾肺肾之经,具有清热解毒、散结消肿、清宣肺气、健脾化湿的作用,为君药;虎耳草、透骨草二味引药入于皮内,有搜风解毒、活血止痛、祛风除湿之功,为臣药;佐以鲜紫花地丁、鲜黄花地丁、金银花、山慈菇、草河车、鲜商路、冰片、广丹,清热解毒、化痰软坚、消肿散结、透邪止痛;没药、乳香、儿茶、血竭、三七活血化瘀、消肿止痛、生肌敛疮为使药。经数百年的临床验证,具有清热解毒、通经活络、破结软坚、活血化瘀、消肿止痛、生肌敛疮之功效。主治各种痈疽、疖肿、无名肿毒、痰核流注、瘰疬、疔疮,皮肤顽癣以及跌打损伤而引起瘀血肿痛者。对于疮疡初期具有消肿止痛;成脓期提脓拔毒;破溃期去腐生肌、保护创面的作用。
2、本发明通过考察浸渍、加水量和蒸馏时间对挥发油量的影响;通过考察水提法、乙酸提取法和乙醇回流法对一笔消提取物的得膏率的影响;通过正交设计法考察加水量、提取时间和提取次数对一笔消提取物中绿原酸含量、得膏率的影响;通过正交设计考察聚乙烯醇PVA-124的用量、乙醇浓度、西黄蓍胶的用量、羧甲基纤维素(CMC)的用量对成膜时间、黏度、成膜质量的影响,对一笔消涂膜剂的制备工艺进行优化。通过三批样品验证工艺稳定,故而采用此方法作为“赵氏一笔消”涂膜剂的制备工艺可达到保证产品质量的目的。
3、本发明通过动物实验证明“赵氏一笔消”涂膜剂可有效减轻大鼠乳头高度和乳头直径的肿胀程度,有效降低大鼠乳腺炎症因子水平,缓解炎症程度;对二甲苯致小鼠耳肿胀及佐剂致大鼠足肿胀均有显著减轻作用,通过443例临床疗效观察,“赵氏一笔消”涂膜剂对乳癖、乳痈、疮疡痈节、无名肿毒、瘿病、瘰疬、流痰、皮肤顽癣的总体痊愈率为73.36%,显效率为21.00%。
附图说明
图1.浸渍前后样品挥发油量的变化;
图2.造模前后各组大鼠乳头高度的变化(注:*P<0.05,与空白组比)
图3.造模前后各组大鼠乳头直径的变化(注:*P<0.05,与空白组比)
图4.治疗后各组大鼠乳头高度的变化(注:##P<0.01,与空白组比;*P<0.05,与模型组比;)
图5.治疗后各组大鼠乳头直径的变化(注:##P<0.01,与空白组比;*P<0.05,与模型组比;)
图6.治疗后各组大鼠乳腺组织C反应蛋白的变化(注:##P<0.01,与空白组比;*P<0.05,与模型组比;)
图7.治疗后各组大鼠乳腺组织TNF-a的变化(注:##P<0.01,与空白组比;*P<0.05,与模型组比)
图8.治疗后各组大鼠乳腺组织IL-8的变化(注:##P<0.01,与空白组比;*P<0.05,与模型组比)
图9.“赵氏一笔消”涂膜剂对各组小鼠耳肿胀率的抑制结果。
具体实施方式
下面结合实施例对本发明提供的具体实施方式作详细说明。
实施例1:
本实施例对“赵氏一笔消”涂膜剂的药材进行成分分析,并通过浸渍、不同加水量(料液比)和蒸馏时间对挥发油量的影响,优选最佳蒸馏条件。
1试药与仪器
1.1试药 “赵氏一笔消”涂膜剂(中药材采购自铜陵禾田中药饮片有限公司)。
1.2仪器 多功能提取罐(上海久益锡山干燥厂),5mL、10mL量筒(上海申玻仪器公司)。
2实验方法与结果
2.1处方分析
白杨树穗 为杨柳科植物毛白杨同属数种植物的雄花序。分布于辽宁、河北、山西、陕西、甘肃、江苏、安徽、浙江、河南等地。味苦、性寒,具有清热解毒,化湿止痢之功效。现代药理学研究发现,其具有抑菌杀菌、增强抵抗力、抗炎抗应激活性。
虎耳草 为虎耳草科植物虎耳草的全草。可入药。主要生长在四川、云南、两广等地。祛风,清热,凉血解毒。主治风疹、湿疹、丹毒等。现代研究发现,其主要含生物碱、硝酸钾及氯化钾、熊果酚甙等物质。
透骨草 为透骨草科透骨草属的多年生草本植物,分布于全国各地,有祛风除湿,舒筋活络,活血止痛,解毒化疹之功效。其有效成分为挥发油,其中以酯类化合物约占挥发油总量的四分之一;酸类化合物约占五分之一;另外还有烷烃、烯烃、醛类和酮类等。酯类化合物为主要成分,具有镇痛、止咳、祛痰、发汗和驱风等药理活性。
金银花 金银花为忍冬科植物忍冬的花蕾,性甘寒,味淡、微苦,气香。自古为清热解毒之良药,用于各种热性病,如身热、发疹、发斑、热毒疮痈、咽喉肿痛等症,均效果显著。现代研究证明,金银花含有绿原酸、木犀草素苷等药理活性成分,对溶血性链球菌、金黄葡萄球菌等多种致病菌及上呼吸道感染致病病毒等有较强的抑制力,金银花性寒,味甘,入肺、心、胃经,具有清热解毒、抗炎、补虚疗风的功效。
鲜紫花地丁 为堇菜科多年生宿根草本,味苦、辛、寒。归心、肝经。具有清热解毒,凉血消肿,清热利湿的作用,主治疔疮,痈肿,瘰疬等疾病。
鲜黄花地丁 菊科多年生草本植物,性寒味苦甘。分布于江苏、湖北、河南、安徽、浙江、黑龙江、吉林、辽宁、内蒙古、河北、山西、陕西、甘肃、青海、山东、浙江、福建北部、台湾、湖南、广东北部、四川、贵州、云南等地区。功能主治:清热解毒,利尿散结。治急性乳腺炎,淋巴腺炎,瘰疬,疔毒疮肿,急性结膜炎,感冒发热,急性扁桃体炎,急性支气管炎,胃炎,肝炎,胆囊炎,尿路感染。化学成分研究显示,其主要含鲜黄花地丁甾醇、胆碱、菊糖、果胶等,具有抗菌、通乳、抗肿瘤、利胆的药理作用。
山慈菇 为兰科植物杜鹃兰、独蒜兰或云南独蒜兰的干燥假鳞茎。性凉,味甘、微辛,主要产地为云南。有清热解毒,化痰散结之功效。主要用于痈肿疔毒,瘰疬痰核。国内外文献报道山慈菇主要成分为菲类、联苄类、黄烷酮类、生物碱类、萜类等。
草河车 为百合科植物七叶一枝花的干燥根茎,性凉,味苦。具有消肿止痛、清热定惊之功效,用于治疗流行性腮腺炎,扁桃体炎,咽喉肿痛,乳腺炎,跌损伤,毒蛇咬伤,疮痈肿痛等。主治痈肿肺痨、跌打损伤、蛇虫咬伤、淋巴结核、骨髓炎等症,是云南白药的主要成分之一。化学成分主要是皂苷:七叶一枝花皂苷,蚤休皂苷A、B,薯蓣皂苷,蚤休甾酮,甲基原薯蓣皂苷,以及丙氨酸,天冬酰胺等多种氨基酸。其水浸剂和煎剂具有抗菌药理作用。
鲜商陆 为商陆科、商陆属多年生粗壮草本植物。主要分布于河南,湖北,山东,浙江,江西等地。味苦、性寒,具有逐水消肿,通利二便之功效,外用具有解毒散结之功效。常用于水肿胀满,外敷治痈肿疮毒。
儿茶 为豆科植物儿茶的去皮枝、干的干燥煎膏。分布于云南南部地区,海南等地区。性苦、涩,微寒,具有活血止痛,止血生肌,收湿敛疮的功效。临床常用于跌扑伤痛,外伤出血,吐血衄血,疮疡不敛,湿疹、湿疮等。
血竭 为棕榈科植物麒麟竭果实渗出的树脂经加工制成,广泛分布于东南亚。具有活血定痛,化瘀止血,生肌敛疮的功效。用于跌打损伤,心腹瘀痛,外伤出血,疮疡不敛。
三七 三七是植物三七的根茎制品,是用三七主根打成的粉,为五加科人参属多年生直立草本植物,主要产地为云南东南部和广西西南部。主要用于跌打瘀血、外伤出血、产后血晕、吐血、衄血等血症。现代药理学研究显示,其主要成分为皂甙,包括人参皂甙Rb1、Rb2、Rc、Rd、Re、Rg1、Rg2、Rh1及三七皂甙R1~4、R6等。此外,尚含止血活性成分田七氨酸及少量黄酮。
处方中透骨草祛风散寒,舒筋活络;乳香、没药均有行气止痛,消肿生肌之功效;现代药理学研究显示以上三味药材有效成分为挥发油,故需蒸馏提取挥发油。较传统水煎煮工艺有技术上的突破创新。
2.2蒸馏工艺研究
2.2.1浸渍对挥发油量的影响
分别取透骨草50份、乳香15份、没药15份组成的2份样品,加8倍量的水,其中样品1直接蒸馏,样品2浸渍12h后蒸馏,分别于1h、2h、3h、4h、5h、6h时观察收集的挥发油量。结果显示,样品1与样品2收集的挥发油量未见明显差异(P>0.05),故选择不浸渍直接蒸馏为制备工艺,变化趋势见表1、图1。
表1浸渍前后样品挥发油量的变化(mL)
2.2.2加水量对挥发油量的影响
分别取透骨草50份、乳香15份、没药15份组成的3份样品,分别加2倍、4倍、8倍量的水,于1h、2h、3h、4h、5h、6h时,分别观察挥发油的收集量,结果显示,加4倍、8倍量水时,收集的挥发油量较加2倍量水时,明显增加,4倍与8倍量水未见明显差异,故从节约能耗角度考虑,选用加4倍量水为工艺条件。结果见表2。
表2加水量对样品挥发油量的影响(mL)
2.2.3蒸馏时间对挥发油量的影响
分别取透骨草50份、乳香15份、没药15份组成的3份样品,于1h、2h、3h、4h、5h、6h、7h时,分别观察挥发油的收集量,结果显示,6h后挥发油量未见明显增加,故选择蒸馏时间为6h为工艺条件。结果见表3。
表3蒸馏时间对样品挥发油量的影响(mL)
结论:“赵氏一笔消”涂膜剂的最优蒸馏工艺为药材加8倍量水,蒸馏时间6h。
实施例2:
本实施例通过不同提取溶剂,以“赵氏一笔消”提取物得膏率为评判标准,优选出最佳提取方式。
1试药与仪器
1.1试药 乙酸(国药化学试剂有限公司,20180704)、乙醇(太仓新太药用乙醇有限公司,201900301);其余试药同实施例1。
1.2仪器 同实施例1。
2实验方法与结果
2.1提取方法的初步选择
根据早期对“赵氏一笔消”涂膜剂中所涉及的药材物质基础的认识,从中药及天然药物有效成分的常用提取、分离方法及具体化学成分组成情况出发,针对处方分析中主要药物所含有的皂甙、苷类、生物碱等化学成分特点,以及医药生产企业通用设备条件要求,我们确定其提取方法在水提醇沉法、乙酸提取法、乙醇热回流法等几种方法中进行筛选。
2.1.1水提法
取白杨树穗250份、虎耳草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份,加12倍量水,煮沸2h,趁热过滤,药渣加10倍量水,再煮沸约1h,趁热过滤,合并滤液并浓缩至每mL浸膏相当于生药5g,浓缩滤液放冷,得浸膏,干燥,称重即得,依上述方法制备3批。
2.1.2乙酸提取法
取白杨树穗250份、虎耳草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份,加8倍量0.2%乙酸溶液,煮沸2h,趁热过滤,药渣加8倍量0.2%乙酸溶液,再煮沸约1h,趁热过滤,合并滤液并浓缩至每mL浸膏相当于生药5g,浓缩滤液,干燥,称重即得,依上述方法制备3批。
2.1.3乙醇回流法
取白杨树穗250份、虎耳草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份,加8倍量70%乙酸溶液,回流4h,趁热过滤,回收乙醇,得浸膏,干燥,称重即得,依上述方法制备3批。
2.1.4提取方法的初步选择结果
结果显示,水提法制备“赵氏一笔消”提取物的浸膏量均值为68.03g,乙酸法提取的浸膏量均值为51.29g,乙醇回流法制备的浸膏量均值为39.88g,见表4。
表4不同提取方法所获得样品的得率(g)
结论:以上表明,水提法能较好的将“赵氏一笔消”处方中的物质提取完全,得率在三种方法中最高,故采用水提法制备“赵氏一笔消”提取物。
实施例3:
本实施例通过正交实验设计,以加水量、提取时间、提取次数为影响因素,以“赵氏一笔消”提取物中绿原酸的含量和得膏率为评判标准,优选出最佳提取条件。
1试药与仪器
1.1试药 乙酸乙酯、石油醚、丙酮,冰醋酸,香草醛,硫酸,二甲苯(均为分析纯,国药化学试剂有限公司);绿原酸对照药材(中国药品生物制品检定所,批号1528-0301);阴性对照样品均按工艺自行提取;其余试药同实施例3。
1.2仪器 Agilent1260高效液相色谱仪(美国安捷伦公司),JA2003A型电子天平(上海精天电子仪器有限公司,精度0.001g),超声仪(上海宁商超声仪有限公司)、5415R离心机(德国艾本德公司),其余仪器同实施例2。
2实验方法与结果
2.1正交设计优化提取工艺
取白杨树穗250份、虎耳草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份。以加水量、提取时间、提取次数为影响因素,参照L9(34)设计正交表:加水量(A)为药材总量的4倍、8倍、12倍;提取时间(B)1h、2h、3h,提取次数(C)1次、2次、3次;以绿原酸含量、得膏率为指标,进行提取工艺优化,比较显著性。结果显示,根据正交表方差分析法,以绿原酸含量为考察指标时加水量A呈现显著性差异(P<0.05),提取时间、提取次数与最优工艺考察水平未见显著差异,见表5、表6。以得膏量为考察指标时,提取次数C呈现显著性差异(P<0.05),加水量、提取时间未见显著差异,见表7、表8。
表5绿原酸正交设计表
表6绿原酸含量偏差分析结果
注:F0.05(2,2)=19.000;F0.01(2,2)=99.000。
表7浸膏量正交设计表
表8浸膏量偏差分析结果
注:F0.05(2,2)=19.000;F0.01(2,2)=99.000。
结论:综上所述,综合考虑能耗成本,采用A3B2C2,即加12倍量水,提取2次,每次2h作为“赵氏一笔消”提取的最佳工艺。
实施例4:
本实施例通过正交实验设计,以聚乙烯醇PVA-124的用量、乙醇浓度、西黄蓍胶的用量、羧甲基纤维素(CMC)的用量为影响因素,以“赵氏一笔消”涂膜剂成膜时间、黏度、抗拉程度、渗透速率为评判标准,优选出最佳制剂条件。
1试药与仪器
所用试药与仪器同实施例3。
2实验方法与结果
2.1正交设计优化制剂成型工艺
以聚乙烯醇PVA-124的用量、乙醇浓度、西黄蓍胶的用量、羧甲基纤维素(CMC)的用量为影响因素,参照L16(45)设计正交表:聚乙烯醇PVA-124的用量(A)10g、20g、30g、40g;乙醇浓度(B)20%、40%、60%、80%,西黄蓍胶的用量(C)5g、10g、15g、20g;羧甲基纤维素(CMC)的用量(D)2g、4g、6g、8g为考察水平,以成膜时间、黏度、成膜质量为考察指标,进行制剂成型工艺优化。结果显示,以成膜时间为考察指标时,聚乙烯醇PVA-124的用量(A)呈显著性差异(P<0.05),乙醇浓度、西黄蓍胶的用量、羧甲基纤维素(CMC)的用量未见显著差异,见表9、表10。以黏度为考察指标时,聚乙烯醇PVA-124的用量(A)、羧甲基纤维素(CMC)的用量(D)与考察指标呈显著差异(P<0.05),乙醇浓度、西黄蓍胶的用量未见显著差异,见表11、表12。以成膜质量为考察指标时,聚乙烯醇PVA-124的用量(A)、西黄蓍胶的用量(C)与考察指标呈显著性差异(P<0.05),乙醇浓度、羧甲基纤维素(CMC)的用量未见显著差异。
表9成膜时间正交设计表
表10成膜时间方差分析表
注:F0.05(3,3)=9.280;F0.01(3,3)=29.500。
表11黏度正交设计表
表12黏度方差分析表
注:F0.05(3,3)=9.280;F0.01(3,3)=29.500。
表13成膜质量正交设计表
表14成膜质量方差分析表
注:F0.05(3,3)=9.280;F0.01(3,3)=29.500。
结论:综上所述,结合实际生产情况,选用A4B2C2D4为“赵氏一笔消”涂膜剂的最优工艺,即加聚乙烯醇PVA-124 40g,乙醇40%,西黄蓍胶10g,羧甲基纤维素(CMC)8g。
制备方法为:取透骨草50份、乳香15份、没药15份,加8倍量,蒸馏6小时,收集蒸馏液,分离挥发油约5mL,药渣加12倍量水,提取2次,每次2小时,过滤提取液,备用。取白杨树穗250份、虎耳草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份。加12倍量水,提取2次,每次2小时,过滤提取液,与蒸馏药渣提取液合并浓缩至每mL浸膏相当于中药材5g,干燥,得一笔消提取物约90g。聚乙烯醇PVA-12440g,西黄蓍胶10g用40%乙醇50mL溶胀后,加入一笔消提取物,蒸馏液,羧甲基纤维素(CMC)8g,纯化水加至200mL,加热,搅拌均匀,即得。
实施例5:
本实施例通过大鼠模型,考察“赵氏一笔消”涂膜剂对乳腺炎症及炎症因子的影响与疗效评判。
1试药与仪器
1.1试药 苯甲酸雌二醇注射液(天津金耀有限公司,181107),黄体酮注射液(天津金耀有限公司,180415),C反应蛋白试剂盒(厦门宝太生物科技有限公司,V1806021);TNF-a试剂盒(上海奥陆生物科技有限公司,201804017);IL-8试剂盒(武汉纯度生物科技有限公司,CXC170922);“赵氏一笔消”涂膜剂按上述工艺制备,药材来自安徽禾田中药饮片有限公司;4%多聚甲醛、PBS、过硫酸氨、氯化钠、氯化钾、磷酸氢二钠、磷酸二氢钾、三羟甲基氨基甲烷、丙烯酰胺、十二烷基硫酸钠等均由国药集团化学试剂有限公司提供。
1.2仪器
游标卡尺(上海阜力测量设备有限公司);匀浆器(上海莱景科学仪器有限公司);恒温箱(上海一恒仪器有限公司);0.2μl–10ml手动移液枪(德国艾本德公司);医用脱脂纱布(上海宏隆医疗用品设备有限公司);一次性护理口罩(上海宏隆医疗用品设备有限公司);无粉乳胶手套(海门市如意实验器材厂)。
2实验方法与结果
2.1动物来源
SD雌性大鼠25只,未孕,鼠龄6周,体重:180-200g。购自上海西普尔-必凯实验有限公司,动物生产许可证号为SCXK(沪)2013-0016;合格证号:2008001659002;使用许可证号:SYXK(沪)2012-0003。SPF级房间饲养,温度:20℃至26℃,湿度:40%~70%;照明时间:12h/天,饲料、水持续供给,不限量自由摄取;鼠盒每周更换。
2.2动物造模与给药
大鼠按完全随机法分为两组:空白组5只和造模组25只,空白组每天肌注0.9%生理盐水,10ml/Kg,造模组每天上午肌注苯甲酸雌二醇注射液0.5mg/Kg,连续25d,造模组改用黄体酮注射液4mg/Kg,连续5d,注射部位为大鼠后腿内侧。造模结束后,造模组按完全随机法分为:模型组、低剂量组、中剂量组、高剂量组4组,每组5只。空白组和模型组均给予空白基质0.25g/只涂抹于乳房处,一日3次;低剂量组、中剂量组和高剂量组分别给予“赵氏一笔消”涂膜剂0.25g/只、0.5g/只、1g/只涂抹于大鼠乳房处,一日3次,连续给药7d,观察大鼠各指标的变化。
2.3“赵氏一笔消”涂膜剂对大鼠乳头高度与直径的影响
分别于造模前,用游标卡尺测量空白组和模型组大鼠的乳头高度和直径,结果显示,造模前,模型组大鼠与空白组大鼠的乳头高度和直径相比,未见明显差异;造模后,模型组大鼠与空白组相比,乳头高度明显增高(P<0.05),乳头直径明显增大(P<0.05),表明造模成功,见图2、图3。经“赵氏一笔消”涂膜剂治疗后,大鼠乳头高度和乳头直径与模型组比均明显减少(P<0.05),表明“赵氏一笔消”涂膜剂可有效减轻大鼠乳腺炎程度,见图4、图5。
2.4“赵氏一笔消”涂膜剂对大鼠乳腺组织炎症相关因子CCL-18、TNF-a、IL-8的变化影响
大鼠用戊巴比妥钠麻醉后,断头处死,取乳腺组织50mg,均浆处理后,用4%多聚甲醛固定30min,PBS洗脱预处理后,按试剂盒说明书方法检测CCL-18、TNF-a、IL-8的含量。结果显示:与空白组比较,模型组大鼠乳腺组织中的CCL-18、TNF-a、IL-8的含量显著升高(P<0.01),经“赵氏一笔消”涂膜剂治疗后的大鼠乳腺组织中CCL-18、TNF-a、IL-8的含量较模型组明显降低(P<0.05),表明“赵氏一笔消”涂膜剂可有效降低大鼠乳腺炎症因子水平,缓解炎症程度,见图6-图8。
实施例6:
本实施例通过小鼠模型,考察“赵氏一笔消”涂膜剂对小鼠耳胀模型疗效评判。
1试药与仪器
1.1试药
二甲苯(国药化学试剂有限公司,20171204),其余试剂同前实例。
1.2仪器
YLS-Q4耳肿打耳器(北京哲成科技有限公司),其余仪器同前实例。
2实验方法与结果
2.1动物来源
雄性ICR小鼠20只,体重20-25g,SPF级,动物来源:常州卡文斯实验动物有限公司,许可证号:SCXK(苏)2016-0010。饲养于室温20~25℃,湿度40~70%SPF级房间,标准饲料自由饮食饮水饲养。
2.2动物造模与给药
小鼠按完全随机法分为模型组和低、中、高剂量组4组,每组5只。模型组给予空白基质0.125g/只涂抹于小鼠右耳处,一日3次;低剂量组、中剂量组和高剂量组分别给予“赵氏一笔消”涂膜剂0.125g/只、0.25g/只、0.5g/只涂抹于小鼠右耳处,一日3次,连续给药7d,末次给药1h后,小鼠右耳两面涂二甲苯0.1mL/只致炎,左耳不涂为正常耳。1h后3%水合氯醛麻醉小鼠,沿耳廓基线剪下双耳,用直径8mm YLS-Q4耳肿打耳器,冲下左耳及右耳同一部位的圆片,于分析天平上称重,计算小鼠耳肿胀度及抑制率。抑制率=(右耳重量-左耳重量)/左耳重量×100%。
结果显示,模型组小鼠耳肿胀率明显升高,经不同剂量的“赵氏一笔消”涂膜剂干预后各组小鼠耳肿抑制率分别为120.87%、100.23%和87.86%,较模型组150.15%均有明显下降。表明“赵氏一笔消”涂膜剂对二甲苯所致的小鼠耳肿胀有明显的预防作用,见图9。
实施例7
本实施例通过大鼠模型,考察“赵氏一笔消”涂膜剂对大鼠足肿胀模型疗效评判。
1试药与仪器
1.1试药
完全弗氏佐剂(Sigma公司,20170901),其余试剂同前实例。
1.2仪器
仪器同前实例。
2实验方法与结果
2.1动物来源
同前实例。
2.2动物分组与给药方法
SD大鼠20只,雄性,体重160~180g,分为模型组和低、中、高剂量组4组,每组5只,模型组给予空白基质0.25g/只,低剂量组、中剂量组和高剂量组分别给予“赵氏一笔消”涂膜剂0.25g/只、0.5g/只、1g/只涂抹于大鼠右后足,一日3次,连续给药7d。末次给药l h后,分别给予大鼠右后足跖健膜下注射完全弗氏佐剂0.l mL/只致炎,分别于0(致炎前)、1-6h(致炎后),游标卡尺测量一次大鼠右后足直径。结果显示,经“赵氏一笔消”涂膜剂干预后,各给药组大鼠足肿胀较模型组明显改善,差异有统计学意义(P<0.05,P<0.01),表明“赵氏一笔消”涂膜剂对炎症有较好的疗效,见表15。
表15治疗前后大鼠足肿胀的变化
(注:*P<0.05,**P<0.01与模型组比)。
实施例8:
本实施例通过临床观察,考察“赵氏一笔消”涂膜剂对疮疡及无名肿毒的疗效评判。
1资料与方法
1.1资料来源
选取2013年1月至2019年1月我院收治的乳癖、乳痈、疮疡痈节、无名肿毒、瘿病、瘰疬、流痰、皮肤顽癣患者443例作为研究对象。其中男性患者147例,女性患者238例;乳癖106例,乳痈63例,疮疡痈节77例,无名肿毒52例,瘿病47例、瘰疬28例、流痰12例、皮肤顽癣58例。纳入标准:符合乳癖、乳痈、疮疡、无名肿毒的诊断标准,年龄16-80岁,进入观察前2周停用其他相关治疗药物。排除标准:对“赵氏一笔消”成分过敏者;妊娠期妇女;乳腺恶性肿瘤患者;甲状腺恶性肿瘤者;有严重心、肝、肾和造血系统等原发疾病及精神病患者。
1.2方法
纳入标准的患者均以“赵氏一笔消”涂膜剂进行治疗一日一次,涂抹于患处,以三个月为一疗程。观察治疗前后的疗效比较。
1.3观察指标与评定标准
观察两组患者的临床疗效和不良反应发生情况。中医症候评分参照《中药新药临床研究指导原则》:以痊愈、显效、有效和无效为评定标准,计算有效率。痊愈:局部症状全部消失,无自觉不适;显效:局部症状范围缩小或大部分消失,全身症状消失或伴有轻度自觉不适;有效:症状不再发展,全身症状减轻;无效:病症进一步发展。
2结果
2.1临床疗效结果
经“赵氏一笔消”涂膜剂治疗后,乳癖患者的痊愈率为77.39%,显效率为20.75%;乳痈患者的痊愈率为52.38%,显效率为28.57%;疮疡痈节患者的痊愈率为79.22%,显效率为19.48%;无名肿毒患者痊愈率为76.92%,显效率为19.23%,瘿病患者的痊愈率为72.34%,显效率为23.40%;瘰疬患者的痊愈率为64.29%,显效率为25.00%;流痰患者的痊愈率为75.00%,显效率为16.67%;皮肤顽癣患者的痊愈率为82.76%,显效率为13.79%;表明“赵氏一笔消”涂膜剂对于上述疾病均取得较好治疗,见表16。
表16治疗三个月后临床疗效结果
2.2不良反应结果
患者用药三个月后,未见有明显不良反应。
实施例9:
本实施例通过现“赵氏一笔消”涂膜剂与原一笔消膏的临床疗效观察,比较两者痊愈率与显效率,评判现“赵氏一笔消”涂膜剂的疗效。
比较结果显示,经改进后的“赵氏一笔消”涂膜剂痊愈率为73.36%,显效率为21.00%,两者合计为94.36%,较原一笔消膏痊愈率(71.00%),显效率(17.00%),两者合计(88.00%),均有提升。表明改进后的“赵氏一笔消”涂膜剂临床疗效优于原一笔消膏,见表17。
表17“赵氏一笔消涂膜剂”与原一笔消膏临床疗效比较
与原一笔消膏相比,本发明的“赵氏一笔消”涂膜剂的优点在于:
能够适用于新的适应症:现代生活方式、饮食、环境、心理等因素造成疾病谱较之前一笔消膏应用的几百年内有所增加。如甲状腺、乳腺等结节性肿块疾病(属中医瘿病、乳癖范畴)。故“赵氏一笔消”涂膜剂在原方基础上增加了金银花、草河车、山慈菇、三七四味药,使整个处方解毒、散结、化瘀止痛的功效得以增强,能够应用于新的适应症。且临床观察对照结果表明:同样的适应症改进后的本发明的“赵氏一笔消”涂膜剂的疗效更好。
对比例1:
取透骨草50份、乳香15份、没药15份,加8倍量,蒸馏6小时,收集蒸馏液,分离挥发油,药渣加12倍量水,提取2次,每次2小时,过滤提取液,备用。取白杨树穗50份、虎耳草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份。加12倍量水,提取2次,每次2小时,过滤提取液,与蒸馏药渣提取液合并浓缩至每mL浸膏相当于中药材5g,干燥,得一笔消提取物,加聚乙烯醇PVA-124 40g,西黄蓍胶10g用40%乙醇50mL溶胀后,加入一笔消提取物,蒸馏液,羧甲基纤维素(CMC)8g,纯化水加至200mL,加热,搅拌均匀,制得“赵氏一笔消”涂膜剂。结果显示得到的涂膜剂有效果但是效果不显著。
对比例2:
取透骨草10份、乳香15份、没药15份,加8倍量,蒸馏6小时,收集蒸馏液,分离挥发油,药渣加12倍量水,提取2次,每次2小时,过滤提取液,备用。取白杨树穗250份、虎耳草10份、鲜紫花地丁50份、鲜黄花地丁50份、金银花10份、山慈菇50份、草河车50份、鲜商陆50份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份。加12倍量水,提取2次,每次2小时,过滤提取液,与蒸馏药渣提取液合并浓缩至每mL浸膏相当于中药材5g,干燥,得一笔消提取物,加聚乙烯醇PVA-124 40g,西黄蓍胶10g用40%乙醇50mL溶胀后,加入一笔消提取物,蒸馏液,羧甲基纤维素(CMC)8g,纯化水加至200mL,加热,搅拌均匀,制得“赵氏一笔消”涂膜剂。结果显示得到的涂膜剂有效果但是效果不显著。
对比例3:
取透骨草50份、乳香15份、没药15份,加8倍量,蒸馏6小时,收集蒸馏液,分离挥发油,药渣加12倍量水,提取2次,每次2小时,过滤提取液,备用。取白杨树穗250份、虎耳草50份、鲜紫花地丁10份、鲜黄花地丁10份、金银花10份、山慈菇10份、草河车10份、鲜商陆10份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份。加12倍量水,提取2次,每次2小时,过滤提取液,与蒸馏药渣提取液合并浓缩至每mL浸膏相当于中药材5g,干燥,得一笔消提取物,加聚乙烯醇PVA-124 40g,西黄蓍胶10g用40%乙醇50mL溶胀后,加入一笔消提取物,蒸馏液,羧甲基纤维素(CMC)8g,纯化水加至200mL,加热,搅拌均匀,制得“赵氏一笔消”涂膜剂。结果显示得到的涂膜剂有效果但是效果不显著。
对比例4:
取透骨草50份、乳香5份、没药5份,加8倍量,蒸馏6小时,收集蒸馏液,分离挥发油,药渣加12倍量水,提取2次,每次2小时,过滤提取液,备用。取白杨树穗250份、虎耳草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、血竭5份、儿茶5份、三七5份、冰片1份、广丹1份。加12倍量水,提取2次,每次2小时,过滤提取液,与蒸馏药渣提取液合并浓缩至每mL浸膏相当于中药材5g,干燥,得一笔消提取物,加聚乙烯醇PVA-124 40g,西黄蓍胶10g用40%乙醇50mL溶胀后,加入一笔消提取物,蒸馏液,羧甲基纤维素(CMC)8g,纯化水加至200mL,加热,搅拌均匀,制得“赵氏一笔消”涂膜剂。结果显示得到的涂膜剂有效果但是效果不显著。
以上已对本发明创造的较佳实施例进行了具体说明,但本发明创造并不限于所述实施例,熟悉本领域的技术人员在不违背本发明创造精神的前提下还可做出种种的等同的变型或替换,这些等同的变型或替换均包含在本申请权利要求所限定的范围内。
Claims (7)
1.一种治疗疮疡及无名肿毒的中药组合物,其特征在于,由如下重量份的原料药组成:白杨树穗100-400份、虎耳草25-75份,透骨草25-75份、鲜紫花地丁25-75份、鲜黄花地丁25-75份、金银花25-75份、山慈菇25-75份、草河车25-75份、鲜商路25-75份、没药9-21份、乳香9-21份、血竭9-21份、儿茶9-21份、三七9-21份、冰片5-15份、广丹0.5-1.5份。
2.根据权利要求1所述的治疗疮疡及无名肿毒的中药组合物,其特征在于,所述的治疗疮疡及无名肿毒的中药组合物由如下重量份的原料药组成:白杨树穗250份,虎耳草50份,透骨草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、鲜黄花地丁50份、山慈菇50份、草河车50份、鲜商陆50份、没药15份、乳香15份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份。
3.一种治疗疮疡及无名肿毒的中药复方制剂,其特征在于,所述的中药复方制剂以权利要求1或2所述的治疗疮疡及无名肿毒的中药组合物作为活性成分。
4.根据权利要求3所述的中药复方制剂,其特征在于,所述的中药复方制剂的剂型为外用涂膜剂。
5.一种如权利要求3或4所述的治疗疮疡及无名肿毒的中药复方制剂的制备方法,其特征在于,包括以下步骤:
取透骨草50份、乳香15份、没药15份,加8倍量,蒸馏6小时,收集蒸馏液,分离挥发油约5mL,药渣加12倍量水,提取2次,每次2小时,过滤提取液,备用;取白杨树穗250份、虎耳草50份、鲜紫花地丁50份、鲜黄花地丁50份、金银花50份、山慈菇50份、草河车50份、鲜商陆50份、血竭15份、儿茶15份、三七15份、冰片10份、广丹1份,加12倍量水,提取2次,每次2小时,过滤提取液,与蒸馏药渣提取液合并浓缩至每mL浸膏相当于中药材5g,干燥,得提取物约90g;聚乙烯醇PVA-124 40g,西黄蓍胶10g用40%乙醇50mL溶胀后,加入一笔消提取物、挥发油、羧甲基纤维素8g,纯化水加至200mL,加热,搅拌均匀,即得。
6.一种如权利要求1或2所述的治疗疮疡及无名肿毒的中药组合物在制备治疗乳癖、乳痈、疮疡痈节、无名肿毒、瘿病、瘰疬、流痰、皮肤顽癣的药物中的应用。
7.一种如权利要求3或4所述的治疗疮疡及无名肿毒的中药复方制剂在制备治疗乳癖、乳痈、疮疡痈节、无名肿毒、瘿病、瘰疬、流痰、皮肤顽癣的药物中的应用。
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