CN113876688A - 抑菌养护洗液及其制备方法 - Google Patents
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- CN113876688A CN113876688A CN202111148681.2A CN202111148681A CN113876688A CN 113876688 A CN113876688 A CN 113876688A CN 202111148681 A CN202111148681 A CN 202111148681A CN 113876688 A CN113876688 A CN 113876688A
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Abstract
本发明公开了抑菌养护洗液及其制备方法,属于清洁护理产品技术领域,具体涉及外用抑菌养护洗液技术领域,以解决现有的感染性皮肤病的治疗存在用药量大,疗程长,疗效不高,副作用大,复发率高的问题,按重量份计,所述抑菌养护洗液包括以下组分:中药提取液10‑23份,中药提取液来自以下中药原料,包括金银花,蒲公英,紫花地丁,白鲜皮,黄柏,黄连,栀子,黄芩,茵陈,苦参,苍术,独活,石菖蒲,土槿皮,蛇床子,地肤子,鸦胆子,地龙,蛇蜕,枯矾,薄荷,艾叶,甘草。本申请的抑菌养护洗液可同时用于治疗尖锐湿疣、霉菌性阴道炎、滴虫性阴道炎,长期使用不至损害肝肾功能,且见效快、复发率低。
Description
技术领域
抑菌养护洗液及其制备方法,本发明属于清洁护理产品技术领域,具体涉及外用抑菌养护洗液技术领域。
背景技术
在日常生活中,临床上常见的霉菌性阴道炎、滴虫性阴道炎及尖锐性湿疣分别由真菌、阴道毛滴虫和HPV感染,常常是因为使用不洁卫生用品,不注意个人卫生,乱性或滥用抗生素等所致。真菌、阴道毛滴虫和HPV感染复发率高,因反复发作,给患者带来了严重的心灵创伤,HPV病毒加重还将存在癌变的风险。
目前针对上述感染性皮肤病,无论是局部还是口服用药,疗程比较长,局部用药可延长至7~14天。症状严重者,外阴局部可用低浓度糖皮质激素软膏或唑类霜剂,然而糖皮质激素长期使用会导致机体免疫力降低,进而阻碍机体组织的修复及愈合。口服的抗真菌类药物多为处方药物,霉菌性阴道炎抗真菌药物为唑类如:克霉唑、伊曲康唑等,副作用大,肝、肾功容易受到明显损害,服药期间必须严格检查肝、肾功能,因肝毒性目前很少应用。据临床调查,运用普通消炎止痒洗剂结合抗真菌药物治疗霉菌性阴道炎、滴虫性阴道炎其复发率较高。临床偶尔会使用皮损内注射干扰素治疗尖锐湿疣,不过与其他治疗联合使用才较为有效;此外,还包括物理治疗和手术治疗,常用的物理疗法包括冷冻治疗、激光治疗、电灼/电凝治疗、电离子治疗和微波治疗等,这些物理治疗是通过直接的破坏作用清除皮损,但费用比较贵,手术时往往需要麻醉,治疗费用通常高于其他方法。也有用中药组合物进行相关治疗的,如:申请号:CN202010055301.X公开了治疗阴道炎的中药组合物及其制备方法,目的在于解决传统中药组合物在治疗阴道炎类似病例过程中其效果不明显,服用不便的问题。其技术方案是,所述治疗阴道炎的中药组合物包括以下组分蛇床子、苦参、黄柏、龙胆草、生百部、白鲜皮、土荆皮、地肤子、蒲公英、艾叶、白矾。而且上述组方中各组分用料普通,其价格便宜,经济实惠,而且经临床对比可知其,有效率高达94%,而且据实际使用效果观察,其疗效显著。
该专利将制得的混合药液3000-4000ml每晚熏洗,将药液置予干净盆内,趁热熏后坐浴外洗,20-30min/次,每日一次,连用7天为1个疗程。存在的缺陷是用药量大,趁热熏后坐浴外洗为传统的治疗方法,有疗效,但是实际操作需要条件,而且麻烦,每次清洗20-30分钟,耗时长,且混合药液会变凉,影响清洗效果。
申请号:CN201310491227.6公开了一种治疗阴道炎的中药组合物,中药组合物中各种原料药材为:山慈菇、煅石膏、青黛、贯众、儿茶、黄连、黄柏、生地榆、冰片、蛇床子、百部、苦参、大黄、白癣皮、仙鹤草、桉叶、防风、荆芥、土茯苓、苦参、花椒、土荆皮、地肤子、连翘、欧活血丹、硼砂、炉甘石、枯矾、木槿皮和松香。该发明用于治疗阴道炎,具有泻火止带、除湿、杀虫止痒、清热解毒、消肿排脓的作用,采用不同药性的中药材,进行了科学配伍,能达到理想的治疗效果,且安全,毒副作用小,制备简单,能直达病灶,治愈时间短,治愈后不易复发。
该专利制备成了冲洗剂,栓剂,胶囊剂及片剂,治疗时,需要将冲洗剂分别与栓剂,胶囊剂和片剂搭配服用,即清洗加内服。治疗时,一日三次,一个月为一个疗程,连续服用1-3个疗程,治疗时最少要1个月的时间,疗程长,耗时并需要花费较多的费用,病人的心理负担重,不利于大规模推广。
申请号:CN02146285.2公开了一种治疗霉菌性阴道炎与滴虫性阴道炎的药物组合物,该药物组合物是由如下原料药制成的:紫花地丁200-300重量份;蒲公英200-300重量份;苦参150-200重量份;地肤子150-200重量份;白鲜皮150-200重量份;黄柏150-200重量份;胡黄连150-200重量份;蛇床子120-180重量份;苍术120-180重量份;艾叶120-180重量份;川木通100-150重量份;珍珠粉15-20重量份;冰片1-3重量份;该药物组合物能治疗霉菌性阴道炎与滴虫性阴道炎。
该专利制霉洁阴胶囊采取口服内治、清洗处阴、阴道置药等内治与外治相结合方法,但疗效仅有79%,疗效不显著,且不清楚疗程多长。
申请号:CN201110096119.X公开了一种治疗霉菌性阴道炎的中药组合物,内服药物为:桑寄生10~20份,当归10~20份,白术10~20份,益母草10~20份,黄芪10~20份,大枣10~20份,菟丝子10~20份,女贞子10~20份,桑椹10~20份,知母10~20份,覆盆子10~20份,五味子10~20份,黄芩10~20份,败酱草10~20份;外用药物为:白头翁10~30份,黄柏10~30份,苦参10~30份,蛇床子10~30份,白藓皮10~30份,艾叶10~30份,丁香10~30份,花椒10~30份,乌梅10~30份,土茯苓10~30份,冰片10~30份,马齿苋10~30份,薄荷10~30份。该发明具有止痒杀虫除菌迅速,消炎抗菌性强,抑菌率高,并且给药方便,药剂易于制造,成本低廉。
该专利在治疗病患时,煎煮取汁2000mL,乘热熏蒸外阴,待药液偏凉后坐浴20~30min,一天两次,7d为一疗程,用药量大,每次清洗20-30分钟,同样存在耗时长,且混合药液会变凉,影响清洗效果。
现有的配方基本只能用于一种病的治疗,由于配方的限制故不能通用,当病人同时患有多种病时,治疗存在用药量大,疗程长,疗效不高,副作用大,病人的身心备受煎熬,此外,有的配方还存在治疗使用上不方便,再者,现有的治疗方式仅仅是抑制了病菌,并没有从根本上治疗上述疾病,导致复发率高。
发明内容
本发明的目的在于:提供抑菌养护洗液及其制备方法,以解决现有的感染性皮肤病的配方大都只能用于治疗一种病,不通用,存在药量大,疗程长,疗效不高,副作用大,病人的身心备受煎熬的问题。
本发明采用的技术方案如下:
抑菌养护洗液,按重量份计,所述抑菌养护洗液包括以下组分:中药提取液10-23份,表面活性剂15-30份,卡松0.08-1份,透明质酸钠0.04-0.8份,清凉剂0.05-0.15份,EDTA-2Na0.05-0.15份,香精0.05-1.5份,苯甲酸钠0.05-1份,水50-75份;中药提取液来自以下中药原料,包括金银花,蒲公英,紫花地丁,白鲜皮,黄柏,黄连,栀子,黄芩,茵陈,苦参,苍术,独活,石菖蒲,土槿皮,蛇床子,地肤子,鸦胆子,地龙,蛇蜕,枯矾,薄荷,艾叶,甘草。
本申请的技术方案中:
金银花,性寒,味甘,入肺、心、胃经;主要提取成分为有机酸、黄酮、挥发油、环烯醚萜、三萜及三萜皂苷和微量元素等;具有抗菌、抗病毒和增强免疫力作用。
蒲公英,寒,味苦、甘。归肝、胃经;含蒲公英固醇、蒲公英素、蒲公英苦素、肌醇和莴苣醇、蒲公英赛醇、咖啡酸及树脂等,对金黄色葡萄球菌、溶血性链球菌及卡他球菌等多种细菌有较强的抑制作用。
紫花地丁,苦、辛,寒,归心、肝经;含棕榈酸,对羟基苯甲酸,反式对羟基桂皮酸,琥珀酸等;对金黄色葡萄球菌、腐生葡萄球菌、粪肠球菌、变形杆菌等有抑制作用,还能抑制疣病毒。
白鲜皮,苦、咸,寒,归胃、肝、肾经;含多种生物碱、内酯类、黄酮、挥发油、甾醇及皂苷类;具有抑制免疫、抗变态反应和抗炎、抗真菌和抑制疣病毒的作用。
黄柏,苦,寒,归肾、膀胱经;含生物碱,苦味素,甾醇类衍生物,以及巴马亭,木兰碱,黄柏碱,蝙蝠葛碱和胍等生物碱等成分;对抗治疗细菌感染和多种皮肤真菌导致的湿疹,湿疮,带下阴痒等。
黄连,苦,寒,归心、脾、胃、肝、胆、大肠经;含生物碱、木脂素、香豆素、黄酮、萜类、甾体、有机酸、挥发油、多糖等;具抗菌和消炎作用,对金黄色葡萄球菌、白喉杆菌等革兰氏阳性菌和大肠杆菌、霍乱弧菌、伤寒杆菌等革兰氏阴性菌,及红色毛藓菌、白色念珠菌等真菌敏感。
栀子,寒,归心、肺、三焦经;含栀子甙,都桷子甙,都桷子甙,都桷子素龙胆双糖甙及酸类成分,如绿原酸,3,4-二-O-咖啡酰其奎宁酸等,还含黄酮类成分;能快速消除感染导致的局部炎症及肿胀。
黄芩,苦,寒,归肺、胆、脾、大肠、小肠经;含多种黄酮类化学物,如黄芩素、黄芩新素等,还含有β-谷甾醇,菜油甾醇及豆甾醇;具有抗细菌、真菌及病毒的作用,能对病患感染局部皮肤粘膜发挥良好的保护作用。
茵陈,苦、辛,微寒,归脾、胃、肝、胆经;含挥发油,绿原酸,香豆素类,滨蒿内酯等;具有除湿、杀虫、止痒,并改善患者的免疫活性。
苦参,苦,性寒,入心、肺、肾、大肠经;含有苦参碱、氧化苦参碱、苦参烯碱、氢苦参碱、槐根碱等多种生物碱,参黄酮、苦参黄酮醇、苦参查耳酮、苦参查耳酮醇、红车轴草根苷、去甲脱水淫羊霍素等;主要为燥湿止痒、祛风杀虫作用。
苍术,辛、苦,温,归脾、胃、肝经;含苍术醇,苍术酮,茅术醇,β-桉叶醇,糖醛等;具有抗病毒,抗细菌,抗真菌及燥湿止痒作用。
独活,味辛、苦,性温,入肾、膀胱经;含欧芹酚甲醚、二氢山芹醇及乙酸酯和当归酸酯等;具有增强患者免疫活性,改善感染局部循环并清除感染导致的局部炎症作用。
石菖蒲,辛、苦,温,归心、胃经;含挥发油,其主要成分是β-细辛醚,顺式甲基异丁香油酚,榄香脂素,细辛醛等;具有抗皮肤真菌的作用,起加强本申请配方的抗菌作用。
土槿皮,辛,温,有毒,归肺、脾经;含土槿丁酸,土槿甲酸,土槿乙酸等,具有杀虫,止痒的作用。
蛇床子,辛、苦,温,有小毒,归肾经;含香豆素类成分,包括佛手柑内酯、欧前胡素、蛇床子素等,还含有挥发油;具有燥湿,杀虫,祛风,止痒的作用,主要作用于滴虫性阴道炎。
地肤子,甘、苦,寒,入肾、膀胱经;含20-羟基蜕皮素、5,20-二羟蜕皮素,还含齐墩果酸、三萜皂苷、脂肪油等;对致病性皮肤真菌有抑制作,还具有除湿止痒作用。
鸦胆子,苦,寒;有小毒,归大肠、肝经;含生物碱鸦胆子碱,鸦胆宁及糖甙、酚性成分和鸦胆子酸等;促使尖锐湿疣赘生物组织细胞发生退行性变与坏死,加快疣体的清除。
地龙,咸,寒,归肝、脾、膀胱经;含多种氨基酸,花生四烯酸,琥珀酸及蚯蚓碱,蚯蚓素等;改善血液循环,促进患者皮肤粘膜新陈代谢,快速恢复正常健康。
蛇蜕,咸、甘、平,归肝经;含骨胶原,氨基酸,糖原,核酸,氨肽酶及β-葡萄糖醛酸酶等;对患者患部皮肤、粘膜感染性炎症引发的血管通透性亢进具有较好抑制作用。
枯矾,主要化学成分是十二水合硫酸铝钾,酸、涩,寒。归肺、脾、肝、大肠经;具有解毒杀虫、燥湿止痒,抗阴道滴虫及清除疣赘生物的作用。
薄荷,辛,凉。归肺、肝经;含挥发性油,黄酮类,氨基酸类,有机酸,萜类成分及醌类成分;具有抗菌、抗病毒、透皮渗透及局部麻醉、止痛作用。
艾叶,辛、苦,温;有小毒,归肝、脾、肾经;含挥发油、倍半萜类、环木菠烷型三萜及黄酮类化合物等;对多种细菌和病毒感染有抑制作用。
甘草,甘,平,归心、肺、脾、胃经;含三萜皂苷,甘草酸,甘草皂苷A3、B2、C2、D3、F3、G2、H2、J2和K2,黄酮类化合物;对药物毒副作用、体内代谢产物及细菌毒素中毒均有一定解毒作用,还具有调和诸药的作用。
本申请以中医(主、辅、佐、使)临床用药配伍为指导原则:金银花、蒲公英、紫花地丁、薄荷清热解毒为主药;黄柏、黄连、黄芩、栀子、苦参苦寒坚阴,与茵陈、独活、石菖蒲、苍术、艾叶苦温胜湿共为辅药;白皮癣、土槿皮、地肤子、蛇床子、鸦旦子、枯矾祛风、杀虫、止痒及地龙、蛇蜕活络,甘草甘温调和诸药共为佐使药减毒增效,以达清热解毒、胜湿杀虫、祛风止痒、活络通瘀的功效。
本申请的抑菌养护液具有清热解毒、燥湿杀虫,抑制细菌、致病性病毒及皮肤真菌,能同时预防治疗尖锐湿疣、滴虫性阴道炎、霉菌性阴道炎、湿疹、皮肤瘙痒、疥癣等皮肤病的作用;可同时治疗尖锐湿疣、霉菌性阴道炎、滴虫性阴道炎,长期使用不至损害肝肾功能,且见效快、复发率低。
优选的,按重量份计,所述抑菌养护洗液包括以下组分:中药提取液16份,表面活性剂22份,卡松0.5份,透明质酸钠0.4份,清凉剂0.1份,EDTA-2Na 0.1份,香精0.8份,苯甲酸钠0.5份,水62份;中药提取液来自以下中药原料,包括金银花,蒲公英,紫花地丁,白鲜皮,黄柏,黄连,栀子,黄芩,茵陈,苦参,苍术,独活,石菖蒲,土槿皮,蛇床子,地肤子,鸦胆子,地龙,蛇蜕,枯矾,薄荷,艾叶,甘草。
进一步的,按重量份计,中药提取液来自以下重量份的中药原料,包括金银花25-35份,蒲公英25-35份,紫花地丁25-35份,白鲜皮25-35份,黄柏10-15份,黄连6-12份,栀子10-15份,黄芩10-15份,茵陈15-25份,苦参15-25份,苍术9-15份,独活9-15份,石菖蒲9-15份,土槿皮15-25份,蛇床子15-25份,地肤子15-25份,鸦胆子10-15份,地龙15-25份,蛇蜕15-25份,枯矾6-12份,薄荷9-15份,艾叶9-15份,甘草6-12份。
优选的,按重量份计,中药提取液来自以下重量份的中药原料,包括金银花30份,蒲公英30份,紫花地丁30份,白鲜皮30份,黄柏12份,黄连9份,栀子13份,黄芩12份,茵陈20份,苦参20份,苍术12份,独活12份,石菖蒲12份,土槿皮20份,蛇床子20份,地肤子20份,鸦胆子12份,地龙20份,蛇蜕20份,枯矾9份,薄荷12份,艾叶12份,甘草9份。
进一步的,表面活性剂包括脂肪醇聚氧乙烯醚硫酸钠,烷基糖苷,椰油酰胺丙基甜菜碱和月桂酰谷胺酸钠中的一种或多种。
进一步的,清凉剂为薄荷脑或冰片。
抑菌养护洗液的制备方法,包括如下步骤:
步骤1、按上述重量份取金银花,薄荷,茵陈,艾叶,苍术,白鲜皮,蛇床子及石菖蒲用水蒸气蒸馏,按上述8种中药重量的2倍收集含芳香挥发性成分的提取蒸馏液,并收集蒸馏后的药渣;按上述重量份,将剩余的中药原料与步骤1的药渣混合均匀后加水煎煮两次,混合两次煎液静置过夜,取上清液浓缩至d=1.0-1.2g/ml,得提取煎液,提取蒸馏液和提取煎液组成中药提取液;
步骤2、取上述中药提取液,按上述重量份,在搅拌下依次缓慢加入表面活性剂,EDTA-2Na和透明质酸钠,搅拌混合均匀得到溶液;
步骤3、按上述重量份,向溶液中加入清凉剂,卡松和香精,经均质乳化至完全混匀,并调整pH至6.0-6.5,得成品。
进一步的,步骤1中煎煮两次,第一加水量为中药重量的7-9倍,煮沸1.2-1.8h后过滤,第二次加水量为中药重量的6-8倍,煮沸0.8-1.2倍后过滤。
进一步的,步骤1中煎煮两次,第一加水量为中药重量的8倍,煮沸1.5h后过滤,第二次加水量为中药重量的7倍,煮沸1h后过滤。
进一步的,步骤1中提取蒸馏液和提取煎液的重量比为1.0:1.5~1.6。
综上所述,由于采用了上述技术方案,本发明的有益效果是:
1、本发明中,抑菌养护洗液按1:10的稀释,稀释液对浓度为3.73×104cfu/ml的大肠杆菌试用菌悬液作用2min,各次抑菌率均﹥50%,产品对于大肠杆菌有抑菌作用;
2、本发明中,抑菌养护洗液按1:10的稀释,稀释液对浓度为2.02×104cfu/ml的金黄色葡萄球菌试验用菌悬液作用2min,各次抑菌率均﹥50%,产品对于金黄色葡萄球菌有抑菌作用;
3、本发明中,抑菌养护洗液按1:10的稀释,稀释液对浓度为2.02×104cfu/ml的白色念珠菌试验用菌悬液作用2min,各次抑菌率均﹥50%,产品对于白色念珠菌有抑菌作用;
4、本发明中,抑菌养护洗液经37℃保温90天后,其1:10的稀释液对金黄色葡萄球菌试验用菌悬液作用2min,各次抑菌率均﹥90%,对大肠杆菌、白色念珠菌试验用菌悬液作用2min,各次抑菌率均﹥50%,与存放前的抑菌效果没有显著差异,表明对大肠杆菌、金黄色葡萄球菌、白色念珠菌的抑菌效果稳定;
5、尖锐性湿疣,由HPV感染引起,属于风热湿毒,本发明的金银花、蒲公英、紫花地丁及薄荷,具有清热解毒,消痈排脓,利湿散结的功效,作为主药;黄柏、黄连、黄芩、栀子、苦参苦寒坚阴,与茵陈、独活、石菖蒲、苍术、艾叶苦温胜湿,凉血解毒,还具有止痒及抗菌消炎之功效,为辅药,白鲜皮、土槿皮、地肤子、蛇床子、鸦旦子、枯矾祛风、杀虫止痒及地龙、蛇蜕活络散结,甘草甘温调和诸药,共为佐使药,诸药合用,以达清热解毒、胜湿杀虫、祛风止痒、活络通瘀,能消除疣赘,达到预防和治疗尖锐性湿疣的目的。
6、霉菌性阴道炎由真菌引起,滴虫性阴道炎由阴道毛滴虫引起,本发明的主药中,金银花,蒲公英,紫花地丁及薄荷均具有抗菌,消炎作用;辅药中黄柏具有治疗细菌感染和多种皮肤真菌导致的湿疹,湿疮,带下阴痒等作用,黄连多种细菌、真菌感染具有良好的抗菌、消炎作用,黄芩对病患感染局部皮肤粘膜发挥良好的保护作用,栀子消除感染导致的局部炎症、肿胀的作用,苦参具有燥湿止痒、祛风杀虫作用,茵陈能除湿、杀虫、止痒,并改善患者的免疫活性,独活具有改善感染局部循环并清除感染导致的局部炎症作用,石菖蒲具有抗菌作用,苍术为抗病毒,抗细菌,抗真菌及燥湿止痒作用,艾叶对多种细菌和病毒感染具有抑制作用;佐使药中的白鲜皮具有抑制免疫(其作为外用药,用于局部组织,具有燥湿杀虫,祛风止痒;对体液免疫有抑制作用,对抗体生成细胞的增殖和循环抗体的生成均有抑制作用;并且在抑制免疫的同时,不导致脾脏萎缩;对非特异性炎症和变态反应炎症均有显著的抑制作用)、抗变态反应和抗炎、抗真菌的作用,土槿皮主要起杀虫和止痒的作用,地肤子对致病性皮肤真菌有抑制作用和除湿止痒作用,蛇床子燥湿,杀虫,祛风,止痒,主要作用于滴虫性阴道炎,鸦旦子和枯矾具有清除疣赘生物和疣病毒的作用,此外还具有解毒杀虫及燥湿止痒的作用,地龙促进患者皮肤粘膜新陈代谢,快速恢复正常健康,蛇蜕对患者患部皮肤、粘膜感染性炎症引发的血管通透性亢进具有较好抑制作用,甘草具有解毒作用,调和诸药,能有效预防和治疗霉菌性阴道炎和滴虫性阴道炎。
此外,从临床病例也可看出,本申请的抑菌养护洗液能同时治疗不同个人的尖锐湿疣、霉菌性阴道炎及滴虫性阴道炎,治疗时间为5天至10天不等,擦洗方式用量少,仅仅使用了擦洗外阴或擦洗外阴结合冲洗器清洗的方式,操作简单且方便。
7、本发明中,金银花、薄荷、茵陈、艾叶、苍术、白鲜皮、蛇床子、石菖蒲8味中药采用水蒸汽蒸馏,目的是收集含芳香挥发性物质,同时将水蒸汽蒸馏后的药渣及剩余的中药原料采用水煮沸提取,目的是得到主要为水溶性成分的药物成分,通过水蒸汽蒸馏和水煮沸提取相结合的方式,既收集了含芳香挥发性物质又收集了水溶性成分,有利于提高药物的临床疗效。
8、本发明的配方采用金银花,蒲公英,紫花地丁,白鲜皮,黄柏,黄连,栀子,黄芩,茵陈,苦参,苍术,独活,石菖蒲,土槿皮,蛇床子,地肤子,鸦胆子,地龙,蛇蜕,枯矾,薄荷,艾叶及甘草作为中药提取液的原料,按主药、辅药、佐使药进行了合理的配伍,主要目的是同时治疗尖锐性湿疣,霉菌性阴道炎和滴虫性阴道炎,根据临床试验例,本申请的配方不会产生任何对患者有害的毒素,也不会对患者的皮肤、黏膜产生刺激或损伤。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合实施例对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅用以解释本发明,并不用于限定本发明。
实施例1
抑菌养护洗液及其制备方法,称取金银花25㎏、蒲公英25㎏、紫花地丁25㎏、白鲜皮25㎏、黄柏10㎏、黄连6㎏、黄芩10㎏、栀子10㎏、茵陈15㎏、苦参15㎏、苍术9㎏、独活9㎏、石菖蒲12㎏、土槿皮15㎏、地肤子15㎏、蛇床子15㎏、鸦旦子10㎏、地龙15㎏、蛇蜕15㎏、枯矾10㎏、薄荷9㎏、艾叶9㎏、甘草6㎏。
配方中金银花,薄荷,茵陈,艾叶,苍术,白鲜皮,蛇床子及石菖蒲用水蒸气蒸馏,按上述8种中药重量的2倍收集含芳香挥发性成分的提取蒸馏液,并收集蒸馏后的药渣,将剩余的中药和药渣混合均匀后加水2500L,煮沸1.5小时后过滤;再加水2100L,煮沸1.0小时后过滤,混合两次滤液静置过夜,取上清液浓缩至d=1.0~1.1g/ml,得到水溶性成分的提取煎液;
取提取蒸馏液25㎏,提取煎液40㎏,并混合均匀,在搅拌下依次缓慢加入脂肪醇聚氧乙烯醚硫酸钠24㎏,烷基糖苷16㎏,椰油酰胺丙基甜菜碱20㎏,EDTA-2Na 0.2㎏,透明质酸钠0.1㎏搅拌至混合均匀。再依次投入薄荷脑0.2㎏,卡松0.2㎏,香精0.2㎏,并经匀质(65-70℃,11.20-14.2MPa压力条件下)充分混合乳化,并调整pH至6.0-6.5,制成抑菌养护洗液。
实施例2
抑菌养护洗液及其制备方法,称取金银花30㎏、蒲公英30㎏、紫花地丁30㎏、白鲜皮20㎏、黄柏12㎏、黄连6㎏,黄芩12㎏、栀子12㎏、茵陈20㎏、苦参20㎏、苍术9㎏、独活9㎏、石菖蒲12㎏、土槿皮20㎏、地肤子20㎏、蛇床子20㎏、鸦旦子10㎏、地龙15㎏、蛇蜕15㎏、枯矾12㎏薄荷12㎏艾叶12㎏甘草6㎏。
配方中金银花、薄荷、茵陈、艾叶、苍术、白鲜皮、蛇床子、石菖蒲8味采用水蒸汽蒸馏,按上述8种中药重量的2倍收集含芳香挥发性成分的提取蒸馏液,并收集蒸馏后的药渣,将剩余的中药和药渣混合均匀后加水2900L,煮沸1.5小时后过滤;再加水2500L,煮沸1小时后过滤,合并两次滤液静置过夜,取上清液浓缩至d=1.0~1.2g/ml,得到水溶性成分的提取煎液。
取提取蒸馏液25㎏,提取煎液40㎏,并混合均匀,在搅拌下依次缓慢加入脂肪醇聚氧乙烯醚硫酸钠20㎏,月桂谷胺酸钠12kg,椰油酰胺丙基甜菜碱20㎏,EDTA-2Na 0.2㎏,透明质酸钠0.1㎏搅拌混匀均质乳化。再依次投入薄荷脑0.2㎏,卡松0.2㎏,香精0.2㎏,经充分拌匀均质(65-70℃,11.20-14.2MPa压力条件下)乳化,并调整pH至6.0-6.5,制成抑菌养护洗液。
实施例3
抑菌养护洗液及其制备方法,称取金银花35㎏、蒲公英35㎏、紫花地丁35㎏、白鲜皮5㎏、黄柏15㎏、黄连9㎏,黄芩12㎏、栀子12㎏、茵陈25㎏、苦参25㎏、苍术12㎏、独活12㎏、石菖蒲15㎏、土槿皮25㎏、地肤子25㎏、蛇床子25㎏、鸦旦子15㎏、地龙20㎏、蛇蜕20㎏、枯矾15㎏薄荷15㎏艾叶15㎏甘草9㎏。
配方中金银花、薄荷、茵陈、艾叶、苍术、白鲜皮、蛇床子、石菖蒲8味中药采用水蒸汽蒸馏,按上述8种中药重量的2倍收集含芳香挥发性成分的提取蒸馏液,并收集蒸馏后的药渣,将剩余的中药和药渣混合均匀后加水3500L,煮沸1.5小时后过滤;再加水3000L,煮沸1小时后过滤,合并两次滤液静置过夜,取上清液浓缩至d=1.0~1.2g/ml,得到水溶性成分的提取煎液。
取提取蒸馏液25㎏,提取煎液40㎏,并混合均匀,再搅拌下依次缓慢加入脂肪醇聚氧乙烯醚硫酸钠20㎏,月桂谷胺酸钠12kg,椰油酰胺丙基甜菜碱20㎏,EDTA-2Na0.2㎏,透明质酸钠0.1㎏搅拌混匀。再依次投入薄荷脑0.2㎏,卡松0.2㎏,香精0.2㎏,取提取蒸馏液25㎏,提取煎液40㎏,经充分均质(65-70℃,11.20-14.2MPa压力条件下)混合乳化,并调整pH至6.0-6.5,制成中药抑菌养护洗液。
临床试验
试验例1
患者成某,男,45岁。病情:生殖器潮湿、瘙痒伴污红色粟状大小赘生物;诊断结果:尖锐湿疣;检查方式:醋酸实验阳性;使用实施例2制备的抑菌养护洗液,按10%比例兑温开水每天早晚各1次擦洗患处,经治疗5日患者愈,自述一切恢复正常。每天用药后前后的症状如下:第一天,开始症状:生殖器潮湿、瘙痒伴污红色赘生物;当日用药后效果:瘙痒稍减轻,但仍感潮湿、红肿。第二天,开始症状:瘙痒较昨日有所减轻,赘生物红肿仍明显;当日用药后效果:瘙痒明显改善,夜间睡眠良好,潮湿感减轻。第三天,开始症状:无明显瘙痒、赘生物红肿逐渐消退;当日用药后效果:赘生物疼痛减轻。第四天,开始症状:赘生物轻微红肿,未出现瘙痒、潮湿;当日用药后效果:症状基本消失。第五天,未出现瘙痒、潮湿、赘生物逐渐消退,未出现红肿,症状完全消失,醋酸实验阴性。
试验例2
患者龚某,女,35岁。自诉“口干口苦,尿黄便结,白带呈豆腐渣样,外阴瘙痒,阴道内有烧灼感”。白带常规及阴道分泌物检查:明确诊断为“霉菌性阴道炎”,即以10%浓度“实施例1制备的抑菌养护洗液”擦洗外阴,用冲洗器将10%浓度的实施例1制备的抑菌养护洗液送至阴道深部冲洗阴道,1日一次,连续7天上述症状消失,患者自述身体恢复正常。
每天用药后前后的症状如下:第一天,开始症状:白带成豆腐渣样、外阴瘙痒,阴内灼热感明显;当日用药后效果:外阴瘙痒稍有缓解,白带仍成豆腐渣样、阴道内灼热感未见减轻。第二天,开始症状:外阴瘙痒稍有改善,白带仍为豆腐渣样;当日用药后效果:阴道瘙痒较前缓解,烧灼感减轻,白带仍为豆腐渣样。第三天,开始症状:阴道瘙痒明显改善,阴道内灼感有所缓解;当日用药后效果:豆腐渣样白带有所减少,未出现口干、口苦,二便正常。第四天,开始症状:瘙痒、烧灼感明显改善,白带仍成豆腐渣状;当日用药后效果:阴道烧灼感及瘙痒缓解,豆腐渣状白带减少。第五天,开始症状:未出现瘙痒及烧灼感,昨夜睡眠可,白带量减少;当日用药后效果:有少量豆腐渣状白带。第六天,开始症状:白带成液体状,其余均正常;当日用药后效果:未出现豆腐渣状白带。第七天,开始症状:豆腐渣状白带及阴道瘙痒、烧灼感均无;当日用药后效果:症状消失,痊愈(白带常规检查正常)。
该病例在第五天至第七天,用少量的实施例1制备的抑菌养护洗液兑温开水清洗。
试验例3
患者刘某,女,45岁。自述“外阴及阴道口瘙痒,白带明显增多,伴有腐臭气味,口苦咽干,尿黄便秘”。经“阴道分泌物检查”明确诊断为“滴虫性阴道炎”,采用10%浓度“实施例3制备的抑菌养护洗液”擦洗外阴,用冲洗器将10%的实施例3制备的抑菌养护洗液送至阴道深部冲洗阴道,一日一次,连续10天,患者自述上述症状消失,身体恢复正常。
每天用药后前后的症状如下:第一天,开始症状:外阴及阴道瘙痒明显、白带腐臭味明显;当日用药后效果:当时使用后瘙痒有所减去,但持续约半天后,症状仍明显。第二天,开始症状:白带量多,瘙痒、腐臭味仍明显;当日用药后效果:瘙痒稍减轻,口干、口苦明显,白带量多伴有腐臭味。第三天,开始症状:口干有所缓解,夜间睡眠欠佳,阴道瘙痒及腐臭味存在;当日用药后效果:白带量多有所改善,腐臭味明显,小便黄、大便干结。第四天,开始症状:阴道瘙痒较昨日减轻,大便干结,小便黄;当日用药后效果:外阴及阴道瘙痒缓解,大便已解,小便正常,白带量减少,仍有异味。第五天,开始症状:瘙痒缓解,白带腐臭味有所改善;当日用药后效果:外阴瘙痒较前改善白带腐臭味变淡。第六天,开始症状:瘙痒明显改善,白带量减少;当日用药后效果:外阴及阴道瘙痒明显缓解,偶尔发作一下,白带腐臭味变淡。第七天,开始症状:白带量少,异味变淡,瘙痒明显改善,昨夜睡眠良好;当日用药后效果:外阴及阴道未出现瘙痒、白带明显缓解、未出现口干、口苦,二便正常。第八天,开始症状:白带量正常,外阴及阴道未出现瘙痒,腐臭味明显变淡;当日用药后效果:白带腐臭味变淡,其余均正常。第九天,开始症状:少量腐臭味白带,其余军均正常;当日用药后效果:未再次出现阴道及外阴瘙痒、未闻及腐臭味白带。第十天,开始症状:白带正常,未出现异味,外阴及阴道瘙痒消失;当日用药后效果:痊愈出院(阴道分泌物检查正常)。
该病例在第七天至第十天,用少量的实施例3制备的抑菌养护洗液兑温开水清洗。
对比例
现有技术中,洁尔阴CN02146285.2和一种治疗霉菌性阴道炎与滴虫性阴道炎的药物及其制备方法仅能用于霉菌性和滴虫性阴道炎;CN202010055301.X治疗阴道炎的中药组合物及其制备方法和CN201310491227.6一种治疗阴道炎的中药组合物及其制备方法仅仅用于治疗阴道炎;CN201110096119.X一种治疗霉菌性阴道炎的中药组合物及其制备方法仅仅用于治疗霉菌性阴道炎,其与本申请的区别及区别带来的效果如表1所示。此外,申请号CN201410184646.X提供了一种六味去疣组合物、其制备方法及其制剂,该专利原料中存在炒斑蝥,对皮肤有伤害(表1未示)。目前公开的配方存在如下问题:第一,仅仅能用于治疗一种病,配方限制不通用;第二,虽然现有技术中也用了一些加强型药物,虽也能治病,但治疗时间长,如申请号:CN201310491227.6公开了一种治疗阴道炎的中药组合物,治疗时最少要1个月的时间,病人受痛苦的时间也长,由于治疗时间长,经济负担重。本申请的配伍合理,能同时治疗尖锐性湿疣,霉菌性阴道炎和滴虫性阴道炎,且治疗周期短5-10天,疗效好,无复发。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.抑菌养护洗液,其特征在于,按重量份计,所述抑菌养护洗液包括以下组分:中药提取液10-23份,表面活性剂15-30份,卡松0.08-1份,透明质酸钠0.04-0.8份,清凉剂0.05-0.15份,EDTA-2Na 0.05-0.15份,香精0.05-1.5份,苯甲酸钠0.05-1份,水50-75份;中药提取液来自以下中药原料,包括金银花,蒲公英,紫花地丁,白鲜皮,黄柏,黄连,栀子,黄芩,茵陈,苦参,苍术,独活,石菖蒲,土槿皮,蛇床子,地肤子,鸦胆子,地龙,蛇蜕,枯矾,薄荷,艾叶,甘草。
2.根据权利要求1所述的抑菌养护洗液,其特征在于,按重量份计,所述抑菌养护洗液包括以下组分:中药提取液16份,表面活性剂22份,卡松0.5份,透明质酸钠0.4份,清凉剂0.1份,EDTA-2Na 0.1份,香精0.8份,苯甲酸钠0.5份,水62份;中药提取液来自以下中药原料,包括金银花,蒲公英,紫花地丁,白鲜皮,黄柏,黄连,栀子,黄芩,茵陈,苦参,苍术,独活,石菖蒲,土槿皮,蛇床子,地肤子,鸦胆子,地龙,蛇蜕,枯矾,薄荷,艾叶,甘草。
3.根据权利要求1或2所述的抑菌养护洗液,其特征在于,按重量份计,中药提取液来自以下重量份的中药原料,包括金银花25-35份,蒲公英25-35份,紫花地丁25-35份,白鲜皮25-35份,黄柏10-15份,黄连6-12份,栀子10-15份,黄芩10-15份,茵陈15-25份,苦参15-25份,苍术9-15份,独活9-15份,石菖蒲9-15份,土槿皮15-25份,蛇床子15-25份,地肤子15-25份,鸦胆子10-15份,地龙15-25份,蛇蜕15-25份,枯矾6-12份,薄荷9-15份,艾叶9-15份,甘草6-12份。
4.根据权利要求3所述的抑菌养护洗液,其特征在于,按重量份计,中药提取液来自以下重量份的中药原料,包括金银花30份,蒲公英30份,紫花地丁30份,白鲜皮30份,黄柏12份,黄连9份,栀子13份,黄芩12份,茵陈20份,苦参20份,苍术12份,独活12份,石菖蒲12份,土槿皮20份,蛇床子20份,地肤子20份,鸦胆子12份,地龙20份,蛇蜕20份,枯矾9份,薄荷12份,艾叶12份,甘草9份。
5.根据权利要求1或2所述的抑菌养护洗液,其特征在于,表面活性剂包括脂肪醇聚氧乙烯醚硫酸钠,烷基糖苷,椰油酰胺丙基甜菜碱和月桂酰谷胺酸钠中的一种或多种。
6.根据权利要求1或2所述的抑菌养护洗液,其特征在于,清凉剂为薄荷脑或冰片。
7.如权利要求1-6任一项所述的抑菌养护洗液的制备方法,其特征在于,包括如下步骤:
步骤1、按上述重量份取金银花,薄荷,茵陈,艾叶,苍术,白鲜皮,蛇床子及石菖蒲用水蒸气蒸馏,按上述8种中药重量的2倍收集含芳香挥发性成分的提取蒸馏液,并收集蒸馏后的药渣;按上述重量份,将剩余的中药原料与步骤1的药渣混合均匀后加水煎煮两次,混合两次煎液静置过夜,取上清液浓缩至d=1.0-1.2g/ml,得提取煎液,提取蒸馏液和提取煎液组成中药提取液;
步骤2、取上述中药提取液,按上述重量份,在搅拌下依次缓慢加入表面活性剂,EDTA-2Na和透明质酸钠,搅拌混合均匀得到溶液;
步骤3、按上述重量份,向溶液中加入清凉剂,卡松和香精,经均质乳化至完全混匀,并调整pH至6.0-6.5,得成品。
8.根据权利要求7所述的制备方法,其特征在于:步骤1中煎煮两次,第一次加水量为中药重量的7-9倍,煮沸1.2-1.8h后过滤,第二次加水量为中药重量的6-8倍,煮沸0.8-1.2h后过滤。
9.根据权利要求7所述的制备方法,其特征在于:步骤1中煎煮两次,第一加水量为中药重量的8倍,煮沸1.5h后过滤,第二次加水量为中药重量的7倍,煮沸1h后过滤。
10.根据权利要求7所述的制备方法,其特征在于:步骤1中提取蒸馏液和提取煎液的重量比为1:1.5~1.6。
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