CN106177475A - 一种用于妇科疾病的中药组合物 - Google Patents
一种用于妇科疾病的中药组合物 Download PDFInfo
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- CN106177475A CN106177475A CN201610850244.8A CN201610850244A CN106177475A CN 106177475 A CN106177475 A CN 106177475A CN 201610850244 A CN201610850244 A CN 201610850244A CN 106177475 A CN106177475 A CN 106177475A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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Abstract
本发明提供一种用于妇科疾病的中药组合物,其包含芦荟等中药成分。本发明的中药组合物可以制成任何一种药剂学上的外用剂型,例如液体制剂、膏霜剂、凝胶剂、膜剂、洗剂、粉剂、气雾喷雾剂、栓剂、透皮吸收制剂,特别是洗剂。所述中药组合物可以经过纳米处理。
Description
技术领域
本发明属于医药领域,具体涉及一种用于妇科疾病的中药组合物。
背景技术
妇科病如***炎、***等,是临床常见的疾病,此类疾病持续时间长,易反复发作,给患者带来痛苦,严重影响患者的身心健康。目前治疗此类疾病多为抗微生物药,这些药物虽有一时效果,但不能达到修复创面的作用;而且长期应用会引起诸多副作用。为了避免此类不良现象的发生,市场需要研制开发一种来源于天然、效果显著、无明显不良反应的治疗妇科病的外用制剂,以减轻患者痛苦。
同时,将纳米技术引入祖国传统医药,有利于药效保持更全面、起效更迅速。因此开发治疗妇科疾病的外用纳米制剂产品具有良好的临床应用前景,对患者是十分有益和必要的。
发明内容
本发明的目的是提供一种用于妇科疾病的中药组合物,其包含芦荟等中药成分。
在本发明的一个实施方案中,所述中药组合物包含芦荟、白芍、南岭荛花和三七等中药成分。
在本发明的一个优选实施方案中,所述中药组合物由下列原料按如下重量份制成:
芦荟10-30份,白芍10-30份,南岭荛花10-30份,三七10-30份,土木香10-20份,山豆根10-20份,天冬5-10份,毛冬青5-10份,甘松5-10份,石刁柏5-10份,白及5-10份,白术5-10份,黄精5-10份,绵马贯众5-10份,川楝5-10份,女贞子5-10份,金樱子5-10份,荜芨1-5份,三叶木通1-5份。
本发明的中药组合物用于营养和修复受损细胞,抑菌止痒,对***、外阴瘙痒症、***炎、***、白带异常、淋病等妇科疾病有非常好的疗效。
本发明一个优选的实施方案中,所述妇科病为***、外阴瘙痒症、***炎、***、白带异常、淋病。
在本发明一个优选的实施方案中,所述中药组合物用于外用。本发明的中药组合物可以加入药学上常用的外用制剂基质、外用制剂可接受的载体来制成任何一种药剂学上的外用剂型,例如液体制剂、膏霜剂、凝胶剂、膜剂、洗剂、粉剂、气雾喷雾剂、栓剂、透皮吸收制剂。
本领域技术人员熟知将所述中药制成外用制剂的方法。特别优选地,本发明的中药组合物经过纳米处理,制成纳米颗粒。然后再制备成如上所述的外用制剂。
在本发明一个优选的实施方案中,所述制剂是洗剂。在本发明一个更优选的实施方案中,所述洗剂是纳米洗剂。
在一个优选的实施方案中,所述纳米洗剂的制备方法包括以下步骤:
将所述原料药材按比例混合,放入超微粉碎机中粉碎成平均粒径为20-120纳米的纳米颗粒;向所述纳米颗粒中加入3~5倍重量的去离子水,充分搅拌使溶解,煎煮2~4小时,过滤,获得药汁,即得纳米洗剂。
在一个具体的实施方案中,制成纳米颗粒的技术采用一轴多筒多维锤式高能纳米球磨机,将药用植物低温烘干处理后(温度在40度以下),保持植物的药性和活性,将植物简单破碎装入一轴多筒多维锤式高能纳米球磨机中,连续研磨7-8个小时,研磨后的植物直径在20-120纳米之间。一轴多筒多维锤式高能纳米球磨机的工作原理为,将传统的球磨改成球锤,在多维运动中产生蹭切、剪切、冲击、研磨动作。通过偏心轴驱动***与偏心轴支撑***的转动带动一个圆盘上装有数个或十数个圆筒状磨罐体上下、左右、前后有规律的多维摆动,猛烈的多维撞击、切剪、研磨,冲击力是传统磨机的几十倍。因多维撞击粉碎无死角,可将生物材料(如中草药、食品、保健品)粉碎至10-800纳米的微纳米粉体。
上述洗剂可以平躺使用。使用前将洗剂装入弹簧瓶,连接导管,将导管慢慢******挤入药液(将弹簧瓶按压到底后慢慢松开,然后再次按压到底,以便于将瓶内的水露全部挤出)。或者使用类似的给药装置,只要能将所述洗剂施用于病变部位即可。
在本发明的药物组合物中,芦荟含芦荟苷等,白芍含芍药苷、芍药苷元酮等,南岒荛花含南荛素、罗汉松脂酚等,三七含皂苷、人参皂苷等,土木香含挥发油、木香酸等,山豆根含苦参碱、高丽槐素等,天冬含天冬酰胺、瓜氨酸等,毛冬青含冬青苷A、黄酮苷等。甘松含广木香醇、甘松香酮等。石刁柏含松柏苷、石刁柏苦素等。白及含白及苷糖、白及醇A等。白术含苍术酮、羟基苍术酮等。黄精,含黄糖、赖氨基酸等。绵马贯众含绵马精BB、AB、黄绵马酸等。川楝含苦楝子醇、苦楝子酮等。女贞子含女贞子苷、洋橄榄苦苷等。金樱子含皂苷、逆没食子酸等。荜芨含荜芨宁酰胺、四氢胡椒酸等。三叶木通含齐墩果酸、木通皂苷等。本发明的中药组合物不仅通过阻断蛋白质合成实现抑菌作用,对大鼠***炎、***模型具有显著的治疗作用,同时其含有的植物精华对受损细胞有营养和修复作用,使细胞恢复活性,增加弹性。
局部刺激性实验研究表明本发明安全,无皮肤刺激、过敏等不良反应。临床多种妇科病患者试用结果表明,本发明对多种妇科病具有显著的治疗作用,有效率达95%以上,使用安全无副作用,且具有修复创面,营养细胞的作用。
具体实施方式
下面结合实施例,对本发明作进一步地描述。
实施例1:
芦荟20克,白芍20克,南岭荛花20克,三七20克,土木香15克,山豆根15克,天冬5克,毛冬青10克,甘松10克,石刁柏10克,白及5克,白术5克,黄精5克,绵马贯众5克,川楝5克,女贞子5克,金樱子5克,荜芨3克,三叶木通3克。
将所述原料药材按比例混合,放入超微粉碎机中粉碎成平均粒径为20-120纳米的纳米颗粒;向所述纳米颗粒中加入4倍重量的去离子水,充分搅拌使溶解,煎煮3小时,过滤,获得药汁,即得纳米洗剂。
实施例2:
芦荟20克,白芍20克,南岭荛花20克,三七20克,土木香15克,山豆根15克,天冬10克,毛冬青5克,甘松5克,石刁柏10克,白及5克,白术5克,黄精5克,绵马贯众5克,川楝5克,女贞子5克,金樱子5克,荜芨5克,三叶木通5克。
将所述原料药材按比例混合,放入超微粉碎机中粉碎成平均粒径为20-120纳米的纳米颗粒;向所述纳米颗粒中加入4倍重量的去离子水,充分搅拌使溶解,煎煮5小时,过滤,获得药汁,即得纳米洗剂。
实施例3
药理试验
本实施例中使用实施例1的纳米洗剂,下称本发明纳米洗剂。
对大鼠***炎的治疗作用:体重200-250g的雌性大鼠,从***注入金黄色葡萄球菌(3×105CFU/ml)和大肠杆菌(1.6×106CFU/ml)的混合菌液,菌液注入量为0.05ml/100g体重,隔日再接种1次。第5天及第7天分别取***分泌物做镜检、细菌培养,并分别分离出金黄色葡萄球菌和大肠杆菌,再分别接种于培养基中,经培养后,做菌株鉴定。镜检及菌株鉴定均为阳性者为感染成功的大鼠。取感染成功的大鼠随机分为4组,模型对照组、本发明纳米洗剂组、氧氟沙星软膏组,每组10只。给药组各只大鼠***内分别注入相应药物,模型对照组各只大鼠***内注入生理盐水,每天1次,连续5天。停药后第1天和第4天取大鼠***分泌物进行鉴定,2次鉴定病原体均为阴性定为转阴。停药后第5天将大鼠解剖,取***标本进行肉眼观察;***标本按充血、水肿、出血3项指标进行评分:无充血、水肿、出血评0分;***粘膜尚平滑有轻度充血,评为1分;***粘膜尚平滑中度充血,可见点状出血点,评为2分;***粘膜不平滑,重度充血,可见大量出血点,组织轻度水肿,评为3分。以模型对照组的分值定为100%(炎症程度),药物组与模型对照组比较,可得出药物组炎症抑制率。用t检验对炎症评分进行统计,用χ2检验对转阴率进行统计。结果表明(见表1),本发明的纳米洗剂对大鼠***炎具有显著的治疗作用,且作用显著优于氧氟沙星组。
表1.对大鼠***炎的治疗作用
x±s.n=10.**P<0.01.
实施例4
局部刺激性实验
取成年家兔8只,雌雄各半,每只动物分笼饲养,先在实验室条件饲养3-4天。然后将家兔脊柱两侧背毛用电动剃毛器剃去,每侧面积5×10cm2。仔细检查脱毛区是否有红肿和损伤,如有应弃之,不能进行试验。采用多次给药的试验方法,在脱毛区涂抹本发明纳米洗剂,每日2次,连续涂抹7天。末次涂抹24小时后用温水洗去涂抹物,分别于l、24、48、72小时后观察局部皮肤反应,如红斑、水肿、脱屑、结痂等,是否有出血点、皮肽粗糙或菲薄等,记录发生时间及消退时间。实验结果表明,在连续涂抹本发明纳米洗剂7天后,各家兔皮肤均未表现出明显的皮肤刺激和过敏反应。表明本发明产品安全,无不良反应。
实施例5
临床试用试验
用本发明实施例1的纳米洗剂,经多种妇科病患者试用,具体病例和疗程见表2。所有患者用本发明外涂病损处,每天1次。患者在治疗期间均不使用任何其它外用药物。疗效标准:治愈:临床症状表现全部消失,病原体镜检为阴性;显效:临床症状表现基本消失,病原体镜检为弱阳性;有效:临床症状表现部分消失,病原体镜检为弱阳性;无效:临床症状表现不变或加重,病原体镜检为阳性。治愈率=治愈人数/总病例X100%;有效率=(治愈人数+显效人数+有效人数)/总病例X100%。结果见表2。临床试用结果表明,多种妇科病患者使用本发明纳米洗剂均有效,绝大多数有效率达90%以上,治愈率均超过80%。
表2本发明纳米洗剂治疗妇科病的临床效果
所有患者在应用本发明期间均未出现皮肤刺激、过敏等不良反应。因此本发明是一种理想的治疗妇科病的外用制剂,疗效显著,使用安全可靠。
Claims (8)
1.一种用于妇科疾病的中药组合物,其包含芦荟等中药成分。
2.权利要求1的中药组合物,包含芦荟、白芍、南岭荛花和三七等中药成分。
3.权利要求1-2的中药组合物,由下列原料按如下重量份制成:芦荟10-30份,白芍10-30份,南岭荛花10-30份,三七10-30份,土木香10-20份,山豆根10-20份,天冬5-10份,毛冬青5-10份,甘松5-10份,石刁柏5-10份,白及5-10份,白术5-10份,黄精5-10份,绵马贯众5-10份,川楝5-10份,女贞子5-10份,金樱子5-10份,荜芨1-5份,三叶木通1-5份。
4.权利要求1-3的中药组合物,其中所述妇科病为***、外阴瘙痒症、***炎、***、白带异常、淋病等。
5.权利要求1-4的中药组合物,其中所述中药组合物用于外用,可以制成任何一种药剂学上的外用剂型,例如液体制剂、膏霜剂、凝胶剂、膜剂、洗剂、粉剂、气雾喷雾剂、栓剂、透皮吸收制剂。
6.权利要求5的中药组合物,其中所述中药组合物经过纳米处理,制成纳米颗粒,然后再制备成外用制剂。
7.权利要求5-6的中药组合物,其中所述洗剂是纳米洗剂。
8.权利要求7的中药组合物,其中所述纳米洗剂的制备方法包括以下步骤:
将所述原料药材按比例混合,放入超微粉碎机中粉碎成平均粒径为20-120纳米的纳米颗粒;向所述纳米颗粒中加入3~5倍重量的去离子水,煎煮2~4小时,过滤,获得药汁,即得纳米洗剂。
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