CN115645508B - 一种用于宫颈疾病的外用中药组合物和外用制剂及其制备方法 - Google Patents
一种用于宫颈疾病的外用中药组合物和外用制剂及其制备方法 Download PDFInfo
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Abstract
本发明属于中药制剂技术领域,提供了一种用于宫颈疾病的外用中药组合物和外用制剂及其制备方法,所述外用中药组合物以重量份数计,包括以下组分:椿皮、炒白果仁、黄柏、蛇床子、苦参、川椒、贯众、青黛、女贞子、赤石脂、熟地黄、鱼腥草、姜炭、苎麻根、苍术、火炭母、败酱草、大黄、龙葵、白及、三七、荜茇、甘草。本发明全方具有清热解毒、攻毒杀虫、生肌敛疮、抗菌消炎的功效,能够治疗宫颈炎、阴道炎、严重宫颈糜烂、HPV阳性导致的宫颈上皮内病变等疾病,疗效显著,无毒副作用,无耐药性。
Description
技术领域
本发明涉及中药制剂技术领域,尤其涉及一种用于宫颈疾病的外用中药组合物和外用制剂及其制备方法。
背景技术
现如今,特异性和非特异性导致的宫颈炎、阴道炎、宫颈潴留囊肿、宫颈增生、严重糜烂、HPV阳性及不明原因导致的宫颈上皮内病变等是常见妇科病,由于其难治愈及易复发的特点成为了困扰女性的主要问题之一。并且,由于治疗不当、游泳、泡温泉、免疫力低下等因素,极易使女性感染HPV病毒,并且最终导致宫颈癌的发生。宫颈癌是发病率较高的恶性肿瘤,成为严重威胁女性身心健康的因素之一。目前,已有多种治疗手段用于治疗妇科炎症和宫颈癌,例如手术切除病灶、放化疗治疗及西医治疗等,但是,手术治疗和放化疗治疗会增加患者的痛苦,且恢复期较长,对于宫颈癌晚期患者的疗效并不显著。而西医治疗主要是服用抗生素,长期服用抗生素会使病菌产生抗药性而降低疗效,治标不治本,难以达到治愈的效果。
近年来,中医药的应用范围越来越广,与国外纯西医相比,多了一种治疗手段,用于临床效果甚佳。中医疗法通过辨证理念治疗感染类疾病的临床疗效显著,中医根据妇科炎症和HPV感染的临床表现将其归属于“带下”范畴,认为其多由脾虚湿热所致,临床证型多以湿热下注、脾虚湿盛最为常见。并且中医治疗存在辩证理论,药性温和不刺激,也不存在产生抗药性的问题,因此,亟待寻找到一种能够用于治疗妇科炎症和宫颈癌疾病的中药组合物。
发明内容
本发明的目的在于提供一种用于宫颈疾病的外用中药组合物和外用制剂及其制备方法,本发明的中药制剂能够治疗宫颈炎、阴道炎、严重宫颈糜烂、HPV阳性导致的宫颈上皮内病变等疾病,疗效显著,无毒副作用,无耐药性。
为了实现上述发明目的,本发明提供以下技术方案:
本发明提供了一种用于宫颈疾病的外用中药组合物,以重量份数计,包括以下组分:椿皮25~35份、炒白果仁25~40份、黄柏25~35份、蛇床子 10~20份、苦参5~15份、川椒5~15份、贯众15~25份、青黛35~45份、女贞子10~20份、赤石脂10~20份、熟地黄30~40份、鱼腥草15~25份、姜炭 15~25份、苎麻根10~20份、苍术15~30份、火炭母30~40份、败酱草15~25 份、大黄30~45份、龙葵25~35份、白及15~25份、三七10~20份、荜茇 15~25份、甘草10~30份。
优选的,所述外用中药组合物以重量份数计,包括以下组分:椿皮27~33 份、炒白果仁28~38份、黄柏26~34份、蛇床子12~18份、苦参8~12份、川椒6~14份、贯众16~24份、青黛36~42份、女贞子13~18份、赤石脂12~18 份、熟地黄32~38份、鱼腥草17~23份、姜炭16~24份、苎麻根12~17份、苍术18~26份、火炭母32~38份、败酱草18~22份、大黄32~42份、龙葵 28~33份、白及17~23份、三七12~18份、荜茇16~24份、甘草15~25份。
优选的,所述外用中药组合物以重量份数计,包括以下组分:椿皮28~32 份、炒白果仁30~35份、黄柏28~32份、蛇床子14~16份、苦参9~11份、川椒8~13份、贯众18~22份、青黛38~40份、女贞子15~16份、赤石脂14~16 份、熟地黄34~36份、鱼腥草19~21份、姜炭18~22份、苎麻根14~16份、苍术20~25份、火炭母34~36份、败酱草19~21份、大黄35~40份、龙葵 29~32份、白及19~21份、三七14~16份、荜茇18~22份、甘草18~22份。
本发明还提供了上述外用中药组合物的制备方法,包括以下步骤:
(1)将各原料中药干燥后粉碎;
(2)将粉碎后的原料加水后煎煮得到提取液;
(3)将提取液浓缩后干燥得到成品。
优选的,步骤(1)中所述粉碎的目数为100~200目。
优选的,步骤(2)中所述粉碎后的原料与水的重量比为1:5~10,煎煮的时间为0.5~1.5h。
优选的,步骤(3)中所述浓缩的时间为2~5h。
优选的,步骤(3)中所述成品的剂型为粉末或凝胶。
本发明还提供了一种用于宫颈疾病的外用制剂,包括上述外用中药组合物和药用辅料。
优选的,所述药用辅料包括溶剂、增溶剂、助溶剂和透皮吸收促进剂中的一种或多种。
相比于现有技术,本发明的有益效果为:
本发明公开了一种用于宫颈疾病的外用中药组合物,包括椿皮、炒白果仁、黄柏、蛇床子、苦参、川椒、贯众、青黛、女贞子、赤石脂、熟地黄、鱼腥草、姜炭、苎麻根、苍术、火炭母、败酱草、大黄、龙葵、白及、三七、荜茇、甘草。本发明采用具有清热解毒、攻毒杀虫、生肌敛疮、抗菌消炎、消肿止血、活血散结的中药原料配伍后使用,主治宫颈肥大、增生、严重糜烂,病毒感染,癌前病变,宫颈癌等,使用后疗效显著且无毒副作用。
本发明直接将中药制剂运送至阴道深处,使其充分与阴道和宫颈接触,中药组合物中的有效成分能够直达病灶快速渗透进细胞发挥作用,能够治疗宫颈炎、阴道炎等炎症,治疗效果显著。本发明的中药制剂还能够杀灭HPV 病毒,减少癌前病变,能够大大减少患者手术的痛苦,疗程短见效快,且治疗一年后未见复发。
具体实施方式
本发明提供了一种用于宫颈疾病的外用中药组合物,以重量份数计,包括以下组分:椿皮25~35份、炒白果仁25~40份、黄柏25~35份、蛇床子 10~20份、苦参5~15份、川椒5~15份、贯众15~25份、青黛35~45份、女贞子10~20份、赤石脂10~20份、熟地黄30~40份、鱼腥草15~25份、姜炭15~25份、苎麻根10~20份、苍术15~30份、火炭母30~40份、败酱草15~25 份、大黄30~45份、龙葵25~35份、白及15~25份、三七10~20份、荜茇 15~25份、甘草10~30份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括椿皮25~35份,优选为27~33份,进一步优选为28~32份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括炒白果仁25~40份,优选为28~38份,进一步优选为30~35份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括黄柏25~35份,优选为26~34份,进一步优选为28~32份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括蛇床子10~20份,优选为12~18份,进一步优选为14~16份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括苦参5~15份,优选为8~12份,进一步优选为9~11份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括川椒5~15份,优选为6~14份,进一步优选为8~13份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括贯众15~25份,优选为16~24份,进一步优选为18~22份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括青黛35~45份,优选为36~42份,进一步优选为38~40份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括女贞子10~20份,优选为13~18份,进一步优选为15~16份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括赤石脂10~20份,优选为12~18份,进一步优选为14~16份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括熟地黄30~40份,优选为32~38份,进一步优选为34~36份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括鱼腥草15~25份,优选为17~23份,进一步优选为19~21份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括姜炭15~25份,优选为16~24份,进一步优选为18~22份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括苎麻根10~20份,优选为12~17份,进一步优选为14~16份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括苍术15~30份,优选为18~26份,进一步优选为20~25份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括火炭母30~40份,优选为32~38份,进一步优选为34~36份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括败酱草15~25份,优选为18~22份,进一步优选为19~21份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括大黄30~45份,优选为32~42份,进一步优选为35~40份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括龙葵25~35份,优选为28~33份,进一步优选为29~32份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括白及15~25份,优选为17~23份,进一步优选为19~21份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括三七10~20份,优选为12~18份,进一步优选为14~16份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括荜茇15~25份,优选为16~24份,进一步优选为18~22份。
在本发明中,以重量份数计,制备所述用于宫颈疾病的外用中药组合物包括甘草10~30份,优选为15~25份,进一步优选为18~22份。
在本发明中,所述中药各组分的药理作用如下:
椿皮为苦木科植物臭椿的干燥根皮或干皮。性寒,味苦、涩,具有清热燥湿,收敛止带,止泻,止血之功效,常用于赤白带下,湿热泻痢,久泻久痢,便血,崩漏。
炒白果仁为银杏科植物银杏的干燥成熟种子。性味甘、苦、涩,具有减肥定喘、止带缩尿的功效,常用于痰多咳嗽、尿频、带下和小便白浊。
黄柏为芸香科植物黄皮树的干燥树皮。味苦,性寒,归肾、膀胱经,有清热燥湿,泻火除蒸,解毒疗疮的功效,用于湿热泻痢,黄疸尿赤,带下阴痒,热淋涩痛,脚气痿蹙,骨蒸劳热,盗汗,遗精,疮疡肿毒,湿疹湿疮。
蛇床子为伞形科植物蛇床的干燥成熟果实。味辛、苦,性温,归肾经,具有燥湿祛风,杀虫止痒,温肾壮阳之功效。常用于阴痒带下,湿疹瘙痒,湿痹腰痛,肾虚阳痿,宫冷不孕。
苦参为豆科植物苦参的干燥根。味苦,性寒,归心、肝、胃、大肠、膀胱经,有清热燥湿,杀虫,利尿之功。用于热痢,便血,黄疸尿闭,赤白带下,阴肿阴痒,湿疹,湿疮,皮肤瘙痒,疥癣麻风,外治滴虫性阴道炎。
川椒为芸香科植物青椒或花椒的干燥成熟果皮。性辛、温,归脾、胃、肾经,具有温中止痛,杀虫止痒的功效,用于脘腹冷痛,呕吐泄泻,虫积腹痛;外治湿疹,阴痒。
贯众为鳞毛蕨科植物粗茎鳞毛蕨的根茎及叶柄残基。性苦、涩,寒,归肝、胃经,具有杀虫、清热、解毒、凉血止血之功效,用于风热感冒;温热癍疹;吐血;咳血;衄血;便血;崩漏;血痢;带下及钩、蛔、绦虫等肠寄生虫病。
青黛为爵床科植物马蓝、蓼科植物蓼蓝、十字花科植物菘蓝的叶或茎叶经加工制得的干燥粉末、团块或颗粒。性咸、寒,归肝经,清热解毒,凉血消斑,泻火定惊,主治温毒发斑,血热吐衄,胸痛咳血,口疮,痄腮,喉痹,小儿惊痫。
女贞子味苦甘、平,归肝、肾经,治阴虚内热,头晕,目花,耳鸣,腰膝酸软,须发早白,滋补肝肾,明目乌发。用于眩晕耳鸣,腰膝酸软、须发早白、目暗不明。
赤石脂为硅酸盐类矿物多水高岭石族多水高岭石。味甘、酸、涩,性温,归大肠、胃经,涩肠,止血,生肌敛疮,用于久泻久痢,大便出血,崩漏带下;外治疮疡久溃不敛,湿疮脓水浸淫。
熟地黄为玄参科植物地黄的块根。性甘,微温,归肝、肾经,功能主治为滋阴,补血,治阴虚血少,腰膝痿弱,劳嗽骨蒸,遗精,崩漏,月经不调,消渴,溲数,耳聋,目昏。
鱼腥草为三白草科植物蕺菜的干燥地上部分。味辛,性寒凉,归肺经,能清热解毒、消肿疗疮、利尿除湿、清热止痢、健胃消食,用于治实热、热毒、湿邪、疾热为患的肺痈、疮疡肿毒、痔疮便血、脾胃积热等。
姜炭为姜科植物姜的干燥根茎经炒炭形成的炮制品。味苦,辛,涩,性温,具有温经止血、温脾止泻的功效,主治虚寒性吐血,便血,崩漏,阳虚泄泻。
苎麻根为荨麻科植物苎麻的根。味甘,性寒,归心、肝经,具有凉血止血,安胎,清热解毒之功效,常用于感冒发热,麻疹高热,尿路感染,肾炎水肿,孕妇腹痛,胎动不安,先兆流产。
苍术为菊科植物茅苍术或北苍术的干燥根茎。味辛、苦,性温,归脾、胃、肝经,燥湿健脾,祛风散寒,明目,用于湿阻中焦,脘腹胀满,泄泻,水肿,脚气痿蹙,风湿痹痛,风寒感冒,夜盲,眼目昏涩。
火炭母为蓼科植物火炭母草的干燥地上部分。清热解毒,利湿消滞,凉血止痒,明止退翳。用于痢疾,消化不良,肝炎,白喉,百日咳,角膜云翳,霉菌性阴道炎,白带,疖肿,小儿脓疱,湿疹,毒蛇咬伤。
败酱草为败酱科植物白花败酱的干燥全草。性凉,味辛、苦。具有清热解毒,祛痰排脓之功效,常用于肠痈,肺痈,痢疾,产后瘀血腹痛,痈肿疔疮。
大黄为蓼科大黄属植物掌叶大黄、唐古特大黄或药用大黄的根及根茎。泻下攻积,清热泻火,凉血解毒,逐瘀通经,主治积滞便秘,血热吐衄,目赤咽肿,热毒疮疡,瘀血诸证,湿热痢疾、黄疸、淋证。
龙葵为茄科植物龙葵的全草。性苦,寒,功能主治为清热,解毒,活血,消肿,治疔疮,痈肿,丹毒,跌打扭伤,慢性气管炎,急性肾炎,用于疮痈肿毒、皮肤湿疹、小便不利、老年慢性气管炎、白带过多、前列腺炎、痢疾。
白及为兰科植物白及的干燥块茎。性苦、甘、涩,微寒,归肺、肝、胃经,收敛止血,消肿生肌,用于咯血,吐血,外伤出血,疮疡肿毒,皮肤皲裂。
三七为五加科植物三七的干燥根。性味甘、微苦,温,归肝、胃经,具有化瘀止血,活血定痛的功效,主治出血症,跌打损伤,瘀血肿痛。
荜茇为胡椒科植物荜茇的干燥近成熟或成熟果穗。性味辛,热,归胃、大肠经,功能主治温中散寒,下气止痛,用于脘腹冷痛,呕吐,泄泻,偏头痛;外治牙痛。
甘草为豆科植物甘草、胀果甘草或光果甘草的干燥根和根茎。味甘,性平,归心、肺、脾、胃经,具有补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药之功效。常用于脾胃虚弱,倦怠乏力,心悸气短,咳嗽痰多,脘腹、四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
本发明还提供了上述外用中药组合物的制备方法,包括以下步骤:
(1)将各原料中药干燥后粉碎;
(2)将粉碎后的原料加水后煎煮得到提取液;
(3)将提取液浓缩后干燥得到成品。
在本发明中,首先将各原料中药干燥后粉碎,所述粉碎的目数为100~200 目,优选为120~180目,进一步优选为140~160目。
在本发明中,所述干燥和粉碎的方法采用常规方法即可。
在本发明中,将粉碎后的原料加水后煎煮得到提取液,所述粉碎后的原料与水的重量比为1:5~10,优选为1:6~9,进一步优选为1:7~8;煎煮的时间为0.5~1.5h,优选为1h。
在本发明中,将提取液浓缩后干燥得到成品,所述浓缩的时间为2~5h,优选为3~4h;所述浓缩和干燥的方法采用常规方法即可。在本发明中,所述成品的剂型为粉末或凝胶。
本发明还提供了一种用于宫颈疾病的外用制剂,包括上述外用中药组合物和药用辅料。
在本发明中,所述药用辅料包括溶剂、增溶剂、助溶剂和透皮吸收促进剂中的一种或多种。
在本发明中,所述外用制剂的使用方法为:消毒外阴,使用湿润的阴道窥器充分暴露宫颈,无菌棉签擦去阴道分泌物和上次制剂,将外用制剂消毒后使用一次性注射器送入,使之均匀覆盖宫颈,使用消毒纱布进行覆盖,最后取出阴道窥器。两天用药一次,每十天为一个疗程,连续治疗3~4个疗程。
下面结合实施例对本发明提供的技术方案进行详细的说明,但是不能把它们理解为对本发明保护范围的限定。
实施例1
本实施例提供了一种用于宫颈疾病的外用中药组合物,包括椿皮32g、炒白果仁30g、黄柏30g、蛇床子16g、苦参8g、川椒10g、贯众20g、青黛 40g、女贞子15g、赤石脂18g、熟地黄34g、鱼腥草20g、姜炭18g、苎麻根 16g、苍术22g、火炭母30g、败酱草22g、大黄38g、龙葵28g、白及20g、三七15g、荜茇20g、甘草25g。
所述外用中药组合物的制备方法为:将各原料药分别干燥后粉碎至100 目,混合均匀后加入5倍质量的水进行煎煮,煎煮时间为1h。煎煮完成后进行减压浓缩,浓缩时间为3h,真空干燥后得到最终产品粉末。
实施例2
本实施例提供了一种用于宫颈疾病的外用中药组合物,包括椿皮25g、炒白果仁40g、黄柏25g、蛇床子20g、苦参15g、川椒8g、贯众15g、青黛 45g、女贞子20g、赤石脂15g、熟地黄40g、鱼腥草15g、姜炭25g、苎麻根 20g、苍术15g、火炭母40g、败酱草15g、大黄30g、龙葵25g、白及15g、三七20g、荜茇25g、甘草30g。
所述外用中药组合物的制备方法为:将各原料药分别干燥后粉碎至120 目,混合均匀后加入10倍质量的水进行煎煮,煎煮时间为1.5h。煎煮完成后进行减压浓缩,浓缩时间为2h,真空干燥后得到最终产品粉末。
实施例3
本实施例提供了一种用于宫颈疾病的外用中药组合物,包括椿皮35g、炒白果仁25g、黄柏35g、蛇床子10g、苦参5g、川椒5g、贯众25g、青黛 35g、女贞子10g、赤石脂20g、熟地黄35g、鱼腥草24g、姜炭15g、苎麻根 10g、苍术30g、火炭母30g、败酱草25g、大黄45g、龙葵35g、白及25g、三七10g、荜茇15g、甘草28g。
所述外用中药组合物的制备方法为:将各原料药分别干燥后粉碎至200 目,混合均匀后加入8倍质量的水进行煎煮,煎煮时间为1.5h。煎煮完成后进行减压浓缩,浓缩时间为3h,真空干燥后得到最终产品粉末。
实验例1
本实验例研究了实施例1~3制备得到的成品对于大鼠宫颈黏膜刺激性的影响,具体方法如下:
选择健康的SD雌性大鼠20只,随机分为4组,每组5只,分别为实施例1组、实施例2组、实施例3组和对照组。取实施例1~3组制备得到的成品0.1ml/100g,将制剂送至大鼠宫颈处,对照组使用生理盐水。制剂与宫颈接触10h,连续给药一周。注射完成后观察记录大鼠的精神、饮食、排泄情况。实验完成后处死大鼠,观察宫颈部变化。
结果表明,给药期间大鼠没有出现死亡,实施例1~3组大鼠精神状态、饮食和排泄情况与对照组无显著性差异,且给药部位也未出现红肿和过敏现象,说明本发明制备得到的中药组合物对于宫颈黏膜没有刺激性。
实验例2
本实验例研究了实施例1~3制备得到的成品对于宫颈炎模型大鼠的治疗效果,具体方法如下:
选择体重相近的SD雌性大鼠100只,使用低浓度苯酚胶浆(20%)制备大鼠宫颈炎模型,取苯酚4ml,阿拉伯树胶4ml,加蒸馏水至20ml,配成 20%的苯酚胶浆,向大鼠阴道深处注入苯酚胶浆,每只大鼠每次注入1.5ml, 1次/2天,共5次,观察大鼠的阴道变化和体征,使用光学显微镜观察大鼠宫颈组织病理形态学变化,对制作的大鼠宫颈炎模型进行鉴定。给药5次后,大部分大鼠宫颈红肿充血,阴道中有白色分泌物,宫颈黏膜脱落形成溃疡,实验大鼠食欲减退,体重减轻、活动减少,使用显微镜观察宫颈组织可见病理性病变,炎细胞浸润,说明成功建造了宫颈炎模型大鼠。
从建模成功的实验大鼠中随机挑选25只,随机分为5组,每组5只,分别为实施例1组、实施例2组、实施例3组、对照组和空白组。取实施例 1~3组制备得到的成品0.1ml/100g,将制剂送至大鼠宫颈处,对照组使用生理盐水,空白组不做任何处理。实施例1~3组和对照组制剂与宫颈接触10h,连续给药一周。实验完成后处死大鼠,取阴道至子宫处组织,观察各处组织的病变情况。结果表明:连续使用本发明成品一周后阴道与子宫内膜病变程度较对照组和空白组轻,且炎症反应也较对照组和空白组轻,说明本发明中药组合物对于宫颈炎具有治疗作用。
实验例3
本实验例研究了实施例1制备得到的成品的临床效果,选择具有宫颈炎、严重宫颈糜烂、阴道炎或白带异常临床症状的女性患者为研究对象,共200 人,随机分为实验组和对照组,实验组和对照组各100人,实验组平均年龄 45.23±6.82岁,对照组平均年龄45.72±8.51岁。实验组在宫颈部位涂覆实施例1制备得到的成品,对照组在宫颈部位涂覆苦参凝胶(市售获得),上药方法如下:消毒外阴,使用湿润的阴道窥器充分暴露宫颈,无菌棉签擦去阴道分泌物和上次制剂,将制剂消毒后使用一次性注射器送入,使之均匀覆盖宫颈,使用消毒纱布进行覆盖,最后取出阴道窥器。两天用药一次,每十天为一个疗程,连续治疗3个疗程。疗效判断标准:治愈:症状完全消失;显效:症状基本消失;有效:症状部分消失;无效:症状无改善。
将得到的实验结果进行统计学分析与检验,疗效分析见表1:
表1实验组和对照组疗效分析结果
由表1可知,在临床试验中实验组有效率为93%,显著优于对照组的 68%,实验组治愈及显效率为63%,显著优于对照组的28%,可见本发明制备得到的中药组合物能够治疗宫颈炎、严重宫颈糜烂、阴道炎、白带异常等疾病,其效果显著优于苦参凝胶。
下面结合宫颈癌病例对本发明制备得到的外用中药组合物疗效作进一步说明:
病例1:冯女士,45岁,西安市人,绝经2年,西京医院查出HPV16, 18,35,58阳性;TCT查出高级别鳞状上皮病变,伴随宫颈3度糜烂,2017 年12月5日入院后用本发明外用中药组合物,做局部24小时持续治疗,连续一周,已不出血,炎症消失,嘱回家休息20天来复诊。于12月25日做第二次局部治疗,用本发明外用中药组合物五天,带五天防感染外用中药合剂。2018年1月14日复诊,先行取宫颈内分泌物标本,再取宫颈脱落液基细胞,进行治疗后的第一次复查,16日出报告:HPV18,35阳性,其他已转阴性;TCT未见上皮内病变,嘱回家休息,预约3月6日复诊,并继续治疗HPV三个阳性,仍然用本发明外用中药组合物五天,带防感染中药外用一周,防止感染,在家休息3月,预约7月2日复诊,再次检测HPV和TCT,结果痊愈,至今未见复发。
病例2:谭女士,62岁,上海人,绝经13年,2020年11月12日初诊,当地医院报告单:HPV四项阳性(18、45、35、53),TCT为ASC和ASC-US,伴较多出血,即用本发明外用中药组合物,局部24小时持续治疗共10天,治疗其中第四天已经不在出血,带调理身体中药,嘱回家休息,一个月后做第二次局部治疗,继续用本发明外用中药组合物,继续治疗五天,嘱回家休息,预约2021年3月2日复诊,继续用本发明外用中药组合物做局部治疗一周,预约2021年5月4日复诊,复查HPV分型,全部阴性,TCT检查,未见上皮内病变,当年12月复查正常,2022年9月复查正常。
由以上实施例可知,本发明提供了一种用于宫颈疾病的外用中药组合物和外用制剂及其制备方法,本发明的中药制剂能够治疗宫颈炎、阴道炎、严重宫颈糜烂、HPV阳性导致的宫颈上皮内病变等疾病,疗效显著,无毒副作用,无耐药性。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (9)
1.一种用于宫颈疾病的外用中药组合物,其特征在于,以重量份数计,由以下组分制成:椿皮25~35份、炒白果仁25~40份、黄柏25~35份、蛇床子10~20份、苦参5~15份、川椒5~15份、贯众15~25份、青黛35~45份、女贞子10~20份、赤石脂10~20份、熟地黄30~40份、鱼腥草15~25份、姜炭15~25份、苎麻根10~20份、苍术15~30份、火炭母30~40份、败酱草15~25份、大黄30~45份、龙葵25~35份、白及15~25份、三七10~20份、荜茇15~25份、甘草10~30份。
2.根据权利要求1所述的外用中药组合物,其特征在于,以重量份数计,由以下组分制成:椿皮27~33份、炒白果仁28~38份、黄柏26~34份、蛇床子12~18份、苦参8~12份、川椒6~14份、贯众16~24份、青黛36~42份、女贞子13~18份、赤石脂12~18份、熟地黄32~38份、鱼腥草17~23份、姜炭16~24份、苎麻根12~17份、苍术18~26份、火炭母32~38份、败酱草18~22份、大黄32~42份、龙葵28~33份、白及17~23份、三七12~18份、荜茇16~24份、甘草15~25份。
3.根据权利要求1或2所述的外用中药组合物,其特征在于,以重量份数计,由以下组分制成:椿皮28~32份、炒白果仁30~35份、黄柏28~32份、蛇床子14~16份、苦参9~11份、川椒8~13份、贯众18~22份、青黛38~40份、女贞子15~16份、赤石脂14~16份、熟地黄34~36份、鱼腥草19~21份、姜炭18~22份、苎麻根14~16份、苍术20~25份、火炭母34~36份、败酱草19~21份、大黄35~40份、龙葵29~32份、白及19~21份、三七14~16份、荜茇18~22份、甘草18~22份。
4.权利要求1~3任一项所述外用中药组合物的制备方法,其特征在于,包括以下步骤:
(1)将各原料中药干燥后粉碎;
(2)将粉碎后的原料加水后煎煮得到提取液;
(3)将提取液浓缩后干燥得到成品。
5.根据权利要求4所述的制备方法,其特征在于,步骤(1)中所述粉碎的目数为100~200目。
6.根据权利要求4所述的制备方法,其特征在于,步骤(2)中所述粉碎后的原料与水的重量比为1:5~10,煎煮的时间为0.5~1.5h。
7.根据权利要求4所述的制备方法,其特征在于,步骤(3)中所述浓缩的时间为2~5h。
8.一种用于宫颈疾病的外用制剂,其特征在于,由权利要求1~3任一项所述的外用中药组合物和药用辅料制备而成。
9.根据权利要求8所述的外用制剂,其特征在于,所述药用辅料包括溶剂、增溶剂、助溶剂和透皮吸收促进剂中的一种或多种。
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