CN112315945A - 治疗妇科疾病的外敷中药组合物、透皮给药贴片及应用 - Google Patents
治疗妇科疾病的外敷中药组合物、透皮给药贴片及应用 Download PDFInfo
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Abstract
本发明公开了治疗妇科疾病的外敷中药组合物,包括以下中药成分:五加皮、千年健、透骨草、羌活、独活、广血竭、乳香、没药、红花、艾叶、桑寄生、续断、三棱、莪术、赤芍、川椒、蒲公英、白芷、防风;由上述中药成分制成的透皮给药贴片,其制备方法包括药物超细粉的制备和药物贴片的制备。同时本发明还公开了透皮给药贴片在治疗妇科疾病中的应用步骤。本发明提供的中药组合物的治愈效果好、副作用少;由该中药组合物制成的透皮给药贴片借助超声导入技术,将药物中的有效成为通过局部皮肤渗透到深层组织,使其迅速达到较高的药物浓度,进而达到治疗的目的,该透皮给药技术定向性好、作用范围准确可控、治疗效率高、局部刺激性小、临床顺应性好。
Description
技术领域
本发明涉及中医药领域,具体涉及一种治疗妇科疾病的外敷中药组合物、透皮给药贴片及应用。
背景技术
智能-透皮给药系统(Smart transdermal drug delivery system TDDS)是指在皮肤表面给药,超声波在规定的时间内生成可变强度和频率的超声波传输,以扩展表面皮肤孔隙,利于或方便将药物输送到皮下的组织与血液。控制可通过调整交替波形的时序来实现渗透的强度变化。其中,国外针对糖尿病研发的U-Strip超声波带,通过胰岛素贴片进行特殊的超声波传播,以扩大皮肤孔隙,使大分子药物能够穿透汗液孔,然后穿透血液。使药物以恒定速率(或接近恒定速率)通过皮肤,进入体循环产生全身或局部治疗作用的新方法。透皮递送虽然具有挑战性,但相对于口服、静脉或肠道等方式,它却有着显著的优势:1、避免肝脏的首过效应和药物在胃肠道的降解,减少用药的个体差异;2、透皮给药比口服给药更稳定地直接进入血液,药效更快、更好;3、维持恒定的有效血药浓度,避免了口服给药等引起的血药浓度峰谷现象,降低了毒副反应;4、使用方便,可持续控制给药速度,灵活给药(可随时中断),特别适合婴儿、老人和不易服药的病人。
超声导入,是一种利用具有高能量和高穿透率的超声波,促进药物经皮透过的方法。超声波增加药物的透皮吸收主要表现为以下4个方面:1、致热作用,也称热效应。超声波在传播过程中,药物介质、皮肤、皮下组织能将超声波变化为热能,导致这些部位血管扩张,皮肤毛孔、汗腺导管口径扩大,破坏皮肤细胞膜的通透性,因而增加药物的吸收;2、机械作用,也称机械影响、辐射压作用。超声波的高速振动,改变皮肤层结构,使角质层脂质双分子层在这种应力下变得无序化,增加渗透性;3、对流运输,也称声微流。这种声微流能促使药物向皮肤、汗腺、毛囊的通道流动和转运,并能产生切变力,降低皮肤屏障,增加药物的扩散性;4、空化效应,也称为空化反应、空化作用,是超声促渗的主要基质。在超声波的作用下,引起介质和细胞内分体分子、气泡的振动及气泡破裂形成的空隙和空囊称之为空化反应。这样形成的通道,大大增加了药物的经皮透过。
超声导入技术与化学促进剂相比安全性更高,超声停止后皮肤屏障功能恢复更快。与离子导入法相比选用药物范围广,不限于电离型和水溶性药物,超声波法可透过皮肤以下5cm,而离子导入法达到的深度不超过1cm,无电刺激现象,更适合于生物大分子药物。
近年来,随着中医学理论和中药药理的深入研究,中药外敷法在治疗妇科病方面愈加显示出特色与优势,本专利将通过超声导入的机理,将药物超有效成分(尤其是芳香类)成分通过透皮给药系统作用于皮肤表面,通过局部皮肤渗透到深层组织,使其迅速达到较高的药物浓度,从而达到治疗目的。这点是本专利的核心。
现代研究认为,皮肤具有吸收作用,药物能透过表皮角质层进入活性表皮,扩散至真皮被毛细血管吸收进入体循环。以上中医学理论和现代医学研究均说明,临床上对局部症状突出、外症明显的病症,中药外敷尤捷于内服,二者如能恰当配合应用,往往疗效更好。
妇科病的发病特点多为局部病变,部位固定不移,如:盆腔炎、宫颈炎、不孕症、痛经等,病灶距体表较近,内服中药是全身给药,一般难达病所,且服药时间较长,易伤及胃气,同时也难以坚持,因此,中药外敷日益引起人们的重视。根据中药外敷法具有温经散寒、活血止痛、祛腐生肌的作用,广泛运用于妇科经、带、胎、产、杂病的治疗,如经行身痛、产后身痛、阴疮、皮肤溃疡、乳房胀痛、乳痈、回乳、局部疼痛、癌症转移疼痛等。中药外敷不但可以治疗所敷部位的病变,而且可以通过经络起到“内属脏腑,外络肢节,沟通表里,贯串上下”的作用。
发明内容
为了解决妇科疾病治疗通过西药治疗以及手术切除的方式带来的细菌耐药问题以及给患者带来巨大的心理和生理负担,本发明利用透皮给药的方式提供了治疗妇科疾病的中药组合物、透皮给药贴片及应用,该中药组合物的治愈效果好、副作用少,该中药组合物制成的透皮给药贴片利用透皮给药方式治疗妇科疾病具备范围精确、治疗效率高。局部刺激性小。临床顺应性好、价格低廉等优势。
本发明提供的治疗妇科疾病的外敷中药组合物,包括以下中药成分:五加皮、千年健、透骨草、羌活、独活、广血竭、乳香、没药、红花、艾叶、桑寄生、续断、三棱、莪术、赤芍、川椒、蒲公英、白芷、防风。
进一步的,所述的中药成分按重量份计,包括五加皮5~20份、千年健5~20份、透骨草20~60份、羌活5~20份、独活5~20份、广血竭5~20份、乳香5~20份、没药5~20份、红花20~60份、艾叶20~60份、桑寄生5~20份、续断5~20份、三棱5~20份、莪术5~20份、赤芍5~20份、川椒3~12份、蒲公英5~20份、白芷5~20份、防风5~20份。
进一步的所述的中药成分按重量计,包括五加皮5~20g、千年健5~20g、透骨草20~60g、羌活5~20g、独活5~20g、广血竭5~20g、乳香5~20g、没药5~20g、红花20~60g、艾叶20~60g、桑寄生5~20g、续断5~20g、三棱5~20g、莪术5~20g、赤芍5~20g、川椒3~12g、蒲公英5~20g、白芷5~20g、防风5~20g。
由上述中药成分制成的透皮给药贴片,其制备方法以下步骤:
Step1、药物超细粉的制备:分别上述中药成分进行清洗,常压鼓风干燥后,使得水分低于5%以下,将上述中药成分经过分次和梯度粉碎,使其达600-1000目筛,混合均匀,得到灰色至褐色状药物超细粉后备用;
Step2、药物贴片的制备:预先用纯水浸泡并完全溶解羧甲基纤维素钠基质,使羧甲基纤维素钠基质浓度为1.5%-0.5%,向带有精确计量泵的挤出机中加入基质溶液和药材超细粉搅拌、混合至均匀,同时开启抽真空装置,真空度为0.04MPa-0.1MPa,将均质的药物超细粉抽真空吸出后,进行涂布成型、成型后经过设定温度45℃,长度6m的烘道进行二次烘干、复合、收卷、模切,制备出规格为10×15cm含水量低于5%的方形无纺布贴膜,重量含量为82±1g/贴,加入空白耦合凝胶贴片中,即制备成药物贴片。
透皮给药贴片在治疗妇科疾病中的应用,包括以下步骤:
(1)贴片位点的选择:根据不同病灶部位、病变组织器官特性,感染病原种类,确定相关贴片的位点和作用方向;
(2)超声电导仪参数的选择:根据患者个体差异的不同,选择适度的超声电导治疗仪参数;
(3)超声电导仪参数的设置:通过编程为每位患者定制程序化药物给药方案来递送规定数量的活性药剂;
(4)药物贴敷的时间控制:将妇科外敷方剂贴片贴敷于病灶部位,通过超声靶向导入病灶30min,每天一次,一次1贴,并保留药贴3-5小时;以利于药物充分透皮吸收,20天为一个疗程;
(5)皮肤孔径的扩张与吸收:通过空白耦合凝胶贴片进行特殊的超声波传播,以扩大皮肤孔隙,使大分子药物能够穿透汗液孔,然后穿透血液;
(6)皮肤的检查:在皮肤贴敷3-5小时后,检查药物贴敷部位是否出现不良反应和对皮肤的刺激性反应,据此调整贴敷时间,使药物贴片保留时间得以适当。
本发明的有益效果是:
本发明提供的中药组合物的治愈效果好、副作用少;由该中药组合物制成的透皮给药贴片借助超声导入技术,将药物中的有效成为通过局部皮肤渗透到深层组织,使其迅速达到较高的药物浓度,进而达到治疗的目的,该透皮给药技术定向性好、作用范围准确可控、治疗效率高、局部刺激性小、临床顺应性好、安全、相对价廉等优势。
具体实施方式
为更好地理解本发明,下面通过以下实施例对本发明作进一步具体的阐述,但不可理解为对本发明的限定,对于本领域的技术人员根据上述发明内容所作的一些非本质的改进与调整,也视为落在本发明的保护范围内。
治疗妇科疾病的外敷中药组合物,包括五加皮、千年健、透骨草、羌活、独活、广血竭、乳香、没药、红花、艾叶、桑寄生、续断、三棱、莪术、赤芍、川椒、蒲公英、白芷、防风。
五加皮,五加科植物细柱五加的干燥根皮。辛、苦,温。归肝、肾经。祛风除湿,补益肝肾,强筋壮骨,利水消肿。用于风湿痹病,筋骨痿软,小儿行迟,体虚乏力,水肿,脚气。
千年健,天南星科植物千年健的干燥根茎。气香,味辛、微苦。苦、辛,温。归肝、肾经。祛风湿,壮筋骨。用于风寒湿痹,腰膝冷痛,拘挛麻木,筋骨痿软。
透骨草,大戟科地构叶属植物地构叶的全草。味辛,性温。入肝、肾经。祛风除湿,舒筋活血,散於消肿,解毒止痛。用于风湿痹痛,筋骨挛缩,寒湿脚气,腰部扭伤,瘫痪,闭经,阴囊湿疹,疮疖肿毒。
羌活,伞形科植物羌活或宽叶羌活的干燥根茎和根。体轻,质脆。气香,味微苦而辛。辛、苦,温。归膀胱、肾经。解表散寒,祛风除湿,止痛。用于风寒感冒,头痛项强,风湿痹痛,肩背酸痛。
独活,伞形科植物重齿毛当归的干燥根。有特异香气。味苦、辛、微麻舌。辛、苦,微温。归肾、膀胱经。祛风除湿,通痹止痛。用于风寒湿痹,腰膝疼痛,少阴伏风头痛,风寒挟湿头痛。
广血竭,棕榈科植物麒麟竭果实渗出的树脂经加工制成。气微,味淡。甘、咸,平。归心、肝经。活血定痛,化瘀止血,生肌敛疮。用于跌打损伤,心腹瘀痛,外伤出血,疮疡不敛。
乳香,橄榄科植物乳香树及同属植物树皮渗出的树脂。辛、苦,温。归心、肝、脾经。活血定痛,消肿生肌。用于胸痹心痛,胃脘疼痛,痛经经闭,产后瘀阻,癥瘕腹痛,风湿痹痛,筋脉拘挛,跌打损伤,痈肿疮疡。
没药,橄榄科植物地丁树或哈地丁树的干燥树脂。辛、苦,平。归心、肝、脾经。散瘀定痛,消肿生肌。用于胸痹心痛,胃脘疼痛,痛经经闭,产后瘀阻,癥瘕腹痛,风湿痹痛,跌打损伤,痈肿疮疡。
红花,菊科植物红花的干燥花。辛,温。归心、肝经。活血通经,散瘀止痛。用于经闭,痛经,恶露不行,癥瘕痞块,胸痹心痛,瘀滞腹痛,胸胁刺痛,跌扑损伤,疮疡肿痛。
艾叶,菊科植物艾的干燥叶。辛、苦,温;有小毒。归肝、脾、肾经。温经止血,散寒止痛;外用祛湿止痒。用于吐血,衄血,崩漏,月经过多,胎漏下血,少腹冷痛,经寒不调,宫冷不孕;外治皮肤瘙痒。醋艾炭温经止血,用于虚寒性出血。
桑寄生,桑寄生科植物桑寄生的干燥带叶茎枝。苦、甘,平。归肝、肾经。祛风湿,补肝肾,强筋骨,安胎元。用于风湿痹痛,腰膝酸软,筋骨无力,崩漏经多,妊娠漏血,胎动不安,头晕目眩。
续断,川续断科植物川续断的干燥根。苦、辛,微温。归肝、肾经。补肝肾,强筋骨,续折伤,止崩漏。用于肝肾不足,腰膝酸软,风湿痹痛,跌扑损伤,筋伤骨折,崩漏,胎漏。酒续断多用于风湿痹痛,跌扑损伤,筋伤骨折。盐续断多用于腰膝酸软。
三棱,黑三棱科植物黑三棱的干燥块茎。辛、苦,平。归肝、脾经。破血行气,消积止痛。用于癥瘕痞块,痛经,瘀血经闭,胸痹心痛,食积胀痛。
莪术,姜科植物莪术、广西莪术或温郁金的干燥根茎。辛、苦,温。归肝、脾经。行气破血,消积止痛。用于癥瘕痞块,淤血经闭,胸痹心痛,食积肿痛。
赤芍,毛茛科植物芍药或川赤芍的干燥根。为毛茛科植物芍药或川赤芍的干燥根。苦,微寒。归肝经。清热凉血,散瘀止痛。用于热入营血,温毒发斑,吐血衄血,目赤肿痛,肝郁胁痛,经闭痛经,癥瘕腹痛,跌扑损伤,痈肿疮疡。
川椒,芸香科植物青椒(香椒、青花椒、山椒、狗椒)或花椒(蜀椒、川椒、红椒、红花椒、大红袍)的干燥成熟果皮。辛、麻、温。归脾、胃、肾经。温中止痛,杀虫止痒。用于脘腹冷痛,呕吐泄泻,虫积腹痛;外治湿疹,阴痒。
蒲公英,菊科植物蒲公英、碱地蒲公英或同属数种植物的干燥全草。苦、甘,寒。归肝、胃经。清热解毒,消肿散结,利尿通淋。用于疔疮肿毒,乳痈,瘰疬,目赤,咽痛,肺痈,肠痈,湿热黄疸,热淋涩痛。
白芷,伞形科植物白芷或杭白芷的干燥根。辛,温。归胃、大肠、肺经。解表散寒,祛风止痛,宣通鼻窍,燥湿止带,消肿排脓。用于感冒头痛,眉棱骨痛,鼻塞流涕,鼻鼽,鼻渊,牙痛,带下,疮疡肿痛。
防风,伞形科植物防风的干燥根。辛、甘,微温。归膀胱、肝、脾经。祛风解表,胜湿止痛,止痉。用于感冒头痛,风湿痹痛,风疹瘙痒,破伤风。
该中药组合物中的三棱破血行气、化瘀止痛;丹皮起到活血祛瘀、凉血消痛;红花活血化淤、散瘀止痛,以扩张局部血管改善微循环,促进组织粘连松解;莪术理气软坚散结以消包块。湿热重加蒲公英;寒湿重加艾叶;气虚明显加党参;瘀血者加三棱、莪术;腰骶坠痛加续断、桑寄生;上述诸药,能够有效起到协同作用,共同达到清热解毒、活血化瘀、行气止痛、消肿散结之效。经过透皮给药吸收,能够直达病灶,软化局部组织粘连,促进炎症吸收,有效改善局部血液循环。
实施例1
对应于上述君臣佐使的中药配伍原则,本实施例中的治疗妇科疾病的外敷中药组合物,以重量计,所述的五加皮10g、千年健10g、透骨草30g、羌活10g、独活10g、广血竭10g、乳香10g、没药10g、红花30g、艾叶30g、桑寄生10g、续断10g、三棱10g、莪术10g、赤芍10g、川椒6g、蒲公英10g、白芷10g、防风10g。
由上述中药成分制成的透皮给药贴片,其制备方法以下步骤:
Step1、药物超细粉的制备:分别上述中药成分进行清洗,常压鼓风干燥后,使得水分低于5%以下,将上述中药成分经过分次和梯度粉碎,使其达600-1000目筛,混合均匀,得到灰色至褐色状药物超细粉后备用;
Step2、药物贴片的制备:预先用纯水浸泡并完全溶解羧甲基纤维素钠基质,使羧甲基纤维素钠基质浓度为1.5%-0.5%,向带有精确计量泵的挤出机中加入基质溶液和药材超细粉搅拌、混合至均匀,同时开启抽真空装置,真空度为0.04MPa-0.1MPa,将均质的药物超细粉抽真空吸出后,进行涂布成型、成型后经过设定温度45℃,长度6m的烘道进行二次烘干、复合、收卷、模切,制备出规格为10×15cm含水量低于5%的方形无纺布贴膜,重量含量为82±1g/贴,加入空白耦合凝胶贴片中,即制备成药物贴片。
透皮给药贴片在治疗妇科疾病中的应用,包括以下步骤:
(1)贴片位点的选择:根据不同病灶部位、病变组织器官特性,感染病原种类,确定相关贴片的位点和作用方向;
(2)超声电导仪参数的选择:根据患者个体差异如,性别、表皮清洁度、老化度、不同部位皮肤构成与脂肪的厚度等情况不同,选择适度的超声电导治疗仪参数,如:NA-A2000B型,多因素调整治疗参数。超声给药系统产生强度和频率可变的超声波传输,脉冲通过改良的透皮贴片,对贴片内的药物产生动力激发作用;
(3)超声电导仪参数的设置:通过编程为每位患者定制程序化药物给药方案来递送规定数量的活性药剂。一般成人标准选择电致孔强度6,超声波强度6,作用时间为30min等临床执行参数。
(4)药物贴敷的时间:将妇科外敷方剂贴片贴敷于病灶部位,通过超声靶向导入病灶30min,每天一次,一次1贴,并保留药贴3-5小时;以利于药物充分透皮吸收,20天为一个疗程;
(5)皮肤孔径的扩张与吸收:通过空白耦合凝胶贴片进行特殊的超声波传播,以扩大皮肤孔隙,使大分子药物能够穿透汗液孔,然后穿透血液。这种扩孔过程,可以使大分子药物经皮转运,而在正常情况下,药物超过1000道尔顿的大小,药物很难经皮转运。超声对药物分子的影响是超声经皮给药系统功能的关键因素。
(6)皮肤的检查:在皮肤贴敷3-5小时后,检查药物贴敷部位是否出现不良反应和对皮肤的刺激性反应。据此调整贴敷时间,使药物贴片保留时间得以适当。
实施例2
对应于上述君臣佐使的中药配伍原则,本实施例中的治疗妇科疾病的外敷中药组合物,以重量计,所述的五加皮6.67g、千年健6.67g、透骨草20g、羌活6.67g、独活6.67g、广血竭6.67g、乳香6.67g、没药6.67g、红花20g、艾叶20g、桑寄生6.67g、续断6.67g、三棱6.67g、莪术6.67g、赤芍6.67g、川椒4g、蒲公英6.67g、白芷6.67g、防风6.67g。
透皮给药贴片的制备方法及其应用步骤同实施例1。
实施例3
对应于上述君臣佐使的中药配伍原则,本实施例中的治疗妇科疾病外敷中药组合物,以重量计,所述的五加皮20g、千年健20g、透骨草60g、羌活20g、独活20g、广血竭20g、乳香20g、没药20g、红花60g、艾叶60g、桑寄生20g、续断20g、三棱20g、莪术20g、赤芍20g、川椒12g、蒲公英20g、白芷20g、防风20g。
透皮给药贴片的制备方法及其应用步骤同实施例1。
实施例4
本实施例采用实施例2中的透皮给药贴片及其应用,结合临床应用及数据统计,得出其临床使用效果,如下:
本实施例中全部病例均选自2018年2月至2019年2月至我院门诊治疗的慢性盆腔痛患者66例,随机分为观察组和对照组。观察组33例,年龄20~45岁,平均(33.9±4.9)岁,病程1~9年,平均(6.7±2.0)年,未育19例,已育14例。对照组33例,年龄18~48岁,平均(32.8±5.1)岁,病程1~10年,平均(6.6±2.3)年,未育18例,已育15例。两组在年龄、患病时间及伴随症状等方面差异无统计学意义(P>0.05),具有可比性。
观察组:利用超声电导治疗仪,根据成人标准选择电致孔强度6,超声波强度6,将妇科疾病外敷方剂利用透皮给药技术将超细粉贴膜靶向导入病灶,作用时间为30min,保留药贴3-5小时,20天为1疗程。对照组:盐酸克林霉素棕榈酸酯分散片150m g,每日4次;妇炎康软胶囊6粒,每日3次,14天为1个疗程。观察组和对照组均治疗3个月,每月用1个疗程。口服药均从月经第1天开始服。
观察指标:下腹疼痛程度评分按数字分级法(NRS评分标准)用0~10代表不同程度的疼痛,治疗前、疗程结束时及疗程结束后3个月由患者填一个最能代表其疼痛程度的数字:0无痛,1~3为轻度疼痛(疼痛不影响睡眠),4~6为中度疼痛,7~9为重度疼痛(不能入睡或者睡眠中痛醒),10剧痛。生活质量评价:SF-36各维度综合评分越高,表明生存质量状况较好。疗效标准:参考2019年版《中药新药临床研究指导原则》慢性盆腔炎疗效评定标准拟定。治愈:治疗后下腹痛或性交痛症状消失,NRS评分为0分,生活质量明显提高,或已妊娠;妇科检查及理化检查正常,停药后3个月内未见复发。显效:治疗后下腹痛症状消失或明显减轻,性交痛很少或没有,评分由重度疼痛或剧痛转为轻度疼痛,生活质量提高,妇科检查及理化检查明显改善。有效:治疗后下腹痛症状减轻,性交痛有时,评分下降1个级别,生活质量有所改善,妇科检查及理化检查有所改善。无效:治疗后腹痛症状无减轻或有加重,性交痛每次或较多,生活质量无改善,妇科检查及理化检查无改善或有加重。总有效率=(治愈病例数+显效病例数+有效病例数)/该组总病例数×100%。
结果,两组治疗前后疼痛程度NRS评分,疗程结束时两组患者疼痛程度NRS评分明显降低,且观察组低于对照组,差异有统计学意(P<0.05)。两组患者治疗前后SF-36量表各维度综合评分明显升高,且观察组高于对照组,差异有统学意义(P<0.05);两组临床疗效比较总有效率观察组比对照组高,差异有统计学意义(P<0.05)。
表1两组治疗前后NRS评分比较(x±s)
组别 | 治疗前 | 疗程结束时 | 疗程结束3个月 |
观察组 | 7.64±1.84 | 3.55±2.41<sup>*</sup> | 3.72±2.32<sup>*</sup> |
对照组 | 7.53±1.91 | 4.59±2.23 | 5.96±2.35 |
t | 0.0654 | 2.7010 | 2.7960 |
p | 0.9841 | 0.0088 | 0.0068 |
注:与治疗前比较,t(结束时)=6.54,t(结束3个月)=6.62,*p<0.05
表2两组治疗前后SF-36量表综合评分(n=33,x±s)
组别 | 治疗前 | 疗程结束时 | 疗程结束3个月 |
观察组 | 289.85±51.17 | 635±73.22<sup>*</sup> | 592.65±80.31<sup>*</sup> |
对照组 | 279.35±50.86 | 525.17±81.21 | 368.36±83.53 |
t | 0.0189 | 1.1790 | 1.8537 |
p | 0.9850 | 0.0427 | 0.0306 |
注:与治疗前比较,t(结束时)=6.38,t(结束3个月)=5.95,*p<0.05
Claims (5)
1.治疗妇科疾病的外敷中药组合物,其特征在于,包括以下中药成分:五加皮、千年健、透骨草、羌活、独活、广血竭、乳香、没药、红花、艾叶、桑寄生、续断、三棱、莪术、赤芍、川椒、蒲公英、白芷、防风。
2.根据权利要求1所述的治疗妇科疾病的外敷中药组合物,其特征在于,所述的中药成分按重量份计,包括五加皮5~20份、千年健5~20份、透骨草20~60份、羌活5~20份、独活5~20份、广血竭5~20份、乳香5~20份、没药5~20份、红花20~60份、艾叶20~60份、桑寄生5~20份、续断5~20份、三棱5~20份、莪术5~20份、赤芍5~20份、川椒3~12份、蒲公英5~20份、白芷5~20份、防风5~20份。
3.根据权利要求1或2所述的治疗妇科疾病的外敷中药组合物,其特征在于,所述的中药成分按重量计,包括五加皮5~20g、千年健5~20g、透骨草20~60g、羌活5~20g、独活5~20g、广血竭5~20g、乳香5~20g、没药5~20g、红花20~60g、艾叶20~60g、桑寄生5~20g、续断5~20g、三棱5~20g、莪术5~20g、赤芍5~20g、川椒3~12g、蒲公英5~20g、白芷5~20g、防风5~20g。
4.根据权利要求3所述的治疗妇科疾病的外敷中药组合物制成的透皮给药贴片,其特征在于,所述的透皮给药贴片的制备方法以下步骤:
Step1、药物超细粉的制备:分别上述中药成分进行清洗,常压鼓风干燥后,使得水分低于5%以下,将上述中药成分经过分次和梯度粉碎,使其达600-1000目筛,混合均匀,得到灰色至褐色状药物超细粉后备用;
Step2、药物贴片的制备:预先用纯水浸泡并完全溶解羧甲基纤维素钠基质,使羧甲基纤维素钠基质浓度为1.5%-0.5%,向带有精确计量泵的挤出机中加入基质溶液和药材超细粉搅拌、混合至均匀,同时开启抽真空装置,真空度为0.04MPa-0.1MPa,将均质的药物超细粉抽真空吸出后,进行涂布成型、成型后经过设定温度45℃,长度6m的烘道进行二次烘干、复合、收卷、模切,制备出规格为10×15cm含水量低于5%的方形无纺布贴膜,重量含量为82±1g/贴,加入空白耦合凝胶贴片中,即制备成药物贴片。
5.透皮给药贴片在治疗妇科疾病中的应用,其特征在于,包括以下步骤:
(1)贴片位点的选择:根据不同病灶部位、病变组织器官特性,感染病原种类,确定相关贴片的位点和作用方向;
(2)超声电导仪参数的选择:根据患者个体差异的不同,选择适度的超声电导治疗仪参数;
(3)超声电导仪参数的设置:通过编程为每位患者定制程序化药物给药方案来递送规定数量的活性药剂;
(4)药物贴敷的时间控制:将妇科外敷方剂贴片贴敷于病灶部位,通过超声靶向导入病灶30min,每天一次,一次1贴,并保留药贴3-5小时;以利于药物充分透皮吸收,20天为一个疗程;
(5)皮肤孔径的扩张与吸收:通过空白耦合凝胶贴片进行特殊的超声波传播,以扩大皮肤孔隙,使大分子药物能够穿透汗液孔,然后穿透血液;
(6)皮肤的检查:在皮肤贴敷3-5小时后,检查药物贴敷部位是否出现不良反应和对皮肤的刺激性反应,据此调整贴敷时间,使药物贴片保留时间得以适当。
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