CN106074995A - 一种用于治疗女性生殖器炎症的抗菌组合物及其用途 - Google Patents
一种用于治疗女性生殖器炎症的抗菌组合物及其用途 Download PDFInfo
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- A—HUMAN NECESSITIES
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Abstract
本发明提供一种用于治疗女性生殖器炎症的抗菌组合物及其用途,所述组合物为龙血竭提取物、重楼提取物、百里香精油、薰衣草精油、美洲大蠊提取物、沙棘油的混合物,本发明还提供了这种抗菌组合物代替抗生素在治疗女性生殖器炎症中的使用,以避免抗生素的耐药性问题。本发明的组合物扩大了广谱抗菌范围,无刺激性,克服了单组方消毒剂的缺点,具有广谱高效的杀菌功效,对革兰氏阳性菌、革兰氏阴性菌和真菌都有效,一分钟100%杀灭白色念珠菌、金黄色葡萄球菌和大肠杆菌;同时又具有良好的安全性。可用于防治各类妇科问题,并且避免了功能类的抗生素产生的耐药性问题。
Description
技术领域
本发明涉及一种用于治疗女性生殖器炎症的抗菌组合物及其用途。
背景技术
由于女性机体相对特殊的生理结构,容易导致感染各种细菌、真菌和霉菌等从而诱发生殖系统感染等一系列疾病。目前由于技术手段的限制,治疗女性生殖道感染的方法通常使用广谱抗生素治疗,但是这种治疗方法容易导致机体细菌产生抗药性,甚至培育出超级细菌。抗生素的耐药性问题是一个全球关注的、日益严峻的问题。女性生殖器炎症近几年来逐年上升,特别是青年女性中滴虫性阴道炎、霉菌性阴道炎和慢性宫颈炎发病率极高,成为当前女性中主要的三种生殖系统感染。女性生殖器炎症主要是由于机体免疫功能低下或发生菌群失调时白色念珠菌、链球菌、肠杆菌等细菌繁殖所致。育龄期女性主要是就诊的高发人群,主要是因为月经期的卫生,性生活带来外部感染,怀孕生产阴道环境改变等。但是,年幼及绝经后女性由于雌激素缺乏,阴道上皮菲薄,阴道抵抗力低下,其实比青春期及育龄妇女易受感染。
发明内容
本发明的目的是提供一种用于治疗女性生殖器炎症的抗菌组合物及其用途,所述组合物为龙血竭提取物、重楼提取物、百里香精油、薰衣草精油、美洲大蠊提取物、沙棘油的混合物,本发明所用都是安全、高效、相容、性价比高、不易产生耐药性、资源充足的原料,配制安全、广谱、高效的抗菌组合物。该抗菌组合物可以治疗由于细菌的感染引发炎症及某些损伤,除了优异的抗菌功能,还具有抗炎及修复的功能。
为实现上述目的,本发明提供如下技术方案:
一种用于治疗女性生殖器炎症的抗菌组合物,所述组合物为龙血竭提取物、重楼提取物、百里香精油、薰衣草精油、美洲大蠊提取物、沙棘油的混合物。
这种用于治疗女性生殖器炎症的抗菌组合物,由以下重量百分比的原料组成:龙血竭提取物0.1%—10%、重楼提取物0.1%—10%、百里香精油0.1%—5%、薰衣草精油0.1%—10%、美洲大蠊提取物0.1%—5%、沙棘油0.1%—10%。
这种用于治疗女性生殖器炎症的抗菌组合物,所述抗菌组合物安全有效的载体成分,是满足具体的产品及其剂型要求的载体成分,所述的产品包括药品、个人护理产品、消毒剂及日用品。
一种用于治疗女性生殖器炎症的抗菌组合物的用途,所述抗菌组合物用于制备治疗女性生殖器炎症的产品,产品剂型依据具体用途及用法选自:凝胶剂、擦剂、洗剂、喷雾剂。
龙血竭:为百合科剑叶龙血树的树脂,主要分布在我国云南及东南亚国家。据《本草纲目》记载,龙血竭性温、平,味甘、咸,无毒,入血分,归肺、脾、肾三经,具有活血化瘀、消肿止痛、收敛止血,软坚散结、生肌敛疮等显著功效。现代医学研究证实,龙血竭含有龙血竭皂甙和抗菌防腐物质,具有祛腐生肌、抗炎镇痛以及改善机体免疫功能的作用。
重楼:重楼,中药名。为百合科植物云南重楼或七叶一枝花的干燥根茎。其味苦,性微寒;有小毒。有清热解毒,消肿止痛,凉肝定惊之功效,常用于疔疮痈肿,咽喉肿痛,蛇虫咬伤,跌扑伤痛,惊风抽搐。
百里香:在中国称为地椒、地花椒、山椒、山胡椒、麝香草等,产于西北地区。百里香可治疗多种疾病,气味甜而又似药草味。百里香在中国的药用记载可追溯到北宋。各种中医典籍都有所记载,《中国药植图鉴》记载其具有镇痉、驱风、强壮作用,主治炎症、痉挛性咳嗽、百日咳、喉头肿痛。现代药用是用其地上部分或全草的鲜样或阴干样,有抗菌、消炎的功能。
薰衣草:原产于地中海沿岸、欧洲各地及大洋洲列岛,后被广泛栽种于英国及南斯拉夫,现在云南引种成功。薰衣草被称为“百草之王”,香气清新优雅,性质温和。是公认为最具有镇静,舒缓,催眠作用的植物。舒缓紧张情绪、镇定心神,平息静气,愈合伤口,去疤痕。控油,再生,消炎,修复。美洲大蠊:是
蜚蠊科中体积最大的昆虫,据文献报道,美洲大蠊提取物能非常明显的促进小鼠创面和烧伤模型肉芽组织增生,并出现相应的量效关系。同时美洲大蠊提取物对家兔创面、烧伤及溃疡模型创伤愈合有明显的促进作用。
沙棘油:系从天然植物沙棘的果实中提取出来的珍贵天然油脂。沙棘油是沙棘的精华,我国元朝沙棘果被列为宫廷的保健品。清朝年间的药典《晶珠本草》。也记载了沙棘的药用保健功能。1977年,沙棘被正式列入《中国药典》:20世纪80年代,沙棘被国家卫生部列为我国第一批药食两用植物品种之首,沙棘的药用价值越来越受到了国内外的关注。医学临床表明,沙棘籽油含有的多种氨基酸,多种维生素、微量元素、不饱和脂肪酸(EPA、DHA),对皮肤和粘膜具有较好的修复作用。
本发明基于中国传统医药技术和国际现代生物医药技术,筛选安全、高效、相容、性价比高、不易产生耐药性、且资源充足的原料,配制安全、广谱、高效的抗菌组合物。该抗菌组合物可以治疗由于细菌的感染引发炎症及某些损伤,除了优异的抗菌功能,还具有抗炎及修复的功能。用本发明的组合物代替抗生素在治疗女性生殖器炎症中的使用,可避免抗生素的耐药性问题。该组合物扩大了广谱抗菌范围,无刺激性,克服了单组方消毒剂的缺点,具有广谱高效的杀菌功效,对革兰氏阳性菌、革兰氏阴性菌、和真菌都有效,一分钟100%杀灭白色念珠菌、金黄色葡萄球菌和大肠杆菌;同时又具有良好的安全性。可用于防治各类妇科问题,并且避免了功能类的抗生素产生的耐药性问题。
具体实施方式
本发明中实施例均以龙血竭、重楼、美洲大蠊的提取粉为例,但是并不局限于提取粉或浸膏等。当以其他形式如提取液的方式应用到产品中时,其在配方中的加入量可根据活性成分含量适当折算。其余成分为:百里香精油、薰衣草精油和沙棘油。
以下通过具体较佳实施例对本发明作进一步详细表述,但本发明并不仅限于以下的实施例。下列各实施例中,所涉及的百分比除非另有说明,均是以重量百分比计算。
1、实施例1-5,抗菌组合物在凝胶剂中的应用。
实施例1-5的凝胶剂组成原料及重量百分比含量如下表1所示。
表1实施例1-5的凝胶剂原料组成
其中实施例1—5的制作工艺包括以下步骤:
按上述配方及用量,提前2天将保湿剂浸入去离子水中,使其溶解后备用;提前1天将增稠剂搅拌溶于水中备用;
将百里香精油、薰衣草精油、沙棘油、和PEG-40氢化蓖麻油在室温下搅拌混匀备用;
常温下取龙血竭、重楼、美洲大蠊的提取粉溶于去离子水中,再加已完全溶解的增稠剂溶液、溶解好的保湿剂溶液及配制好的PEG-40氢化蓖麻油溶液,搅拌均匀后,用中和剂调PH值至5.0-7.5,再补加去离子水至全量,搅匀后凝固得本发明凝胶剂。
2、实施例6-10,抗菌组合物在擦剂中的应用。
实施例6-10的擦剂组成原料及重量百分比含量如下表2所示。
表2实施例6-10的凝胶剂原料组成
其中实施例6—10的制作工艺包括以下步骤:
按上述配方及用量,将百里香精油、薰衣草精油、沙棘油、和PEG-40氢化蓖麻油在室温下搅拌混匀备用;常温下取龙血竭、重楼、美洲大蠊的提取粉溶于去离子水中,搅拌均匀,加入配制好的PEG-40氢化蓖麻油溶液,再加入丙二醇、甘油、乙醇适量,并加水至剩余量,搅拌均匀,即得。
3、实施例11-15,抗菌组合物在洗剂中的应用。
实施例11-15的洗剂组成原料及重量百分比含量如下表3所示。
表3实施例11-15的洗剂原料组成
上述实施例11-15的洗剂的制备方法如下:
按上述配方及用量,将百里香精油、薰衣草精油、沙棘油和PEG-40氢化蓖麻油在室温下搅拌混匀备用;
常温下取龙血竭、重楼、美洲大蠊的提取粉溶于去离子水中,搅拌均匀,加入配制好的PEG-40氢化蓖麻油溶液,再加入月桂醇硫酸钠、苯甲酸钠适量使溶解,加水至剩余量,搅匀,静置24小时,滤过,即得。
4、实施例16-20,抗菌组合物在喷雾剂中的应用。
实施例16-20的喷雾剂组成原料及重量百分比含量如下表4所示。
表4实施例16-20的喷雾剂原料组成
上述实施例16-20的喷雾剂的制备方法如下:
按上述配方及用量,将百里香精油、薰衣草精油、沙棘油和PEG-40氢化蓖麻油在室温下搅拌混匀备用;
将龙血竭、重楼、美洲大蠊的提取粉等固体小料加入水中,搅拌溶解;加入配制好的PEG-40氢化蓖麻油溶液,再加入山梨醇、甘油,搅拌均匀;再加入乙醇搅拌至透明均一溶液,静置24小时,滤过,即得。
本发明的抗菌组合物在治疗女性生殖器炎症的临床及试验研究
1、临床研究
1.1一般性资料:本药物制剂应用于临床观察病例60例,年龄24~45岁。病程最短者3个月,最长者达3年。
1.2诊断标准:(1)阴道分泌物牛奶样均质,有臭味。(2)阴道PH值>4.5。(3)胺试验阳性。(4)线索细胞阳性(>20%)。上述4条中3条阳性即可临床诊断,其中第4条为诊断金标准。
1.3试验方法:按上述颗粒剂制备方法制备临床样品,规格为每袋10克,五天为一疗程,一天三袋,分早、中、晚三次饭前半小时服用。服药期间忌食生冷、辛辣、刺激及腐烂之物。空白组口服安慰剂颗粒剂,五天为一疗程,一天三袋,分早、中、晚三次饭前半小时服用。
1.4疗效标准:痊愈:症状消失,阴道分泌物检查正常。有效:阴道分泌物检查正常而其症状未消失,或者症状减轻而阴道分泌物检查异常。无效:症状和阴道分泌物检查同治疗前。
1.5治疗效果:见表5。
表5两组疗效比较:
组别 | n | 痊愈 | 有效 | 无效 | 总有效率(%) |
治疗组 | 30 | 12 | 14 | 4 | 86.7 |
空白组 | 30 | 1 | 4 | 25 | 16.7 |
可见,本发明制得的抗菌组合物能够安全有效治疗阴道炎,且无毒副作用。
2、主要药效学试验研究
2.1实验材料
(1)动物小鼠,体重(20±2)g;SD大鼠,体重(200±20)g;家兔,体重1.9~2.1kg;豚鼠,体重250~300g。
(2)本发明洗液,由云南西草资源开发有限公司提供,批号0901,规格100ml/瓶,数量50瓶。临床用法用量取10ml用温水稀释至500~1000ml,一日2次,外洗患处。洁尔阴洗液,四川省成都思威公司;二甲苯,上海化学试剂总厂;右旋糖酐,上海华源长富药业有限公司;磷酸组胺,上海伯奥生物科技有限公司提供。
(3)仪器精密电子天平(北京赛多利斯股份公司),SHA-C控温水浴震荡器(深圳天南海北实业公司),计时器(贵阳恒因生物公司),足跖容积测量仪。
2.2实验方法与结果
2.2.1体外抑菌实验
(1)方法:最低抑菌浓度(MIC)测定,取本发明洗液和洁尔阴洗液各lml,用无菌肉汤lml作倍比稀释,采用液体试管抑菌法(检测管8支,药物对照管1支,细菌对照管1支),加入菌量0.1ml(3X106/m1),培养24小时,然后将以上培养物分别定量转种至琼脂平板中培养24小时,观察记录实验结果。
(2)结果:本发明洗液对金黄色葡萄球菌、铜绿假单胞菌、大肠杆菌、乙型链球菌、白色念珠菌和新型念珠菌均有不同程度的抑菌作用。结果见表6。
表6体外抑菌实验结果
细菌名称 | 菌种号 | 本发明洗液(MIC) | 洁尔阴洗液(MIC) |
金黄色葡萄球菌 | CMCC26003 | 0.04 | 0.03 |
大肠杆菌 | ATCC44185 | 0.04 | 0.03 |
铜绿假单胞菌 | ATCC27853 | 0.02 | 0.03 |
乙型链球菌 | CMCC10213 | 0.08 | 0.06 |
白色念珠菌 | ATCC10213 | 0.4 | 0.3 |
新型念珠菌 | ATCC32264 | 0.2 | 0.15 |
2.2.2对二甲苯致小鼠耳廓肿胀的影响实验
(1)方法:取50只小鼠随机分为5组,每组10只。各组分别为阴性对照组(蒸馏水);洁尔阴洗液组(20%);本发明洗液高、中、低剂量组(5%、10%、20%)。实验当日各组小鼠右耳前后两面涂药一次(O.1m1),对照组涂以等量蒸馏水。1h后各给药组以蒸馏水洗去药液,用于棉球擦净。采用二甲苯(25μl/每耳)致小鼠耳廓肿胀法,观察记录各组小鼠左右耳片重量,计算肿胀度(即左右耳片重量之差值),并求出抑制率。
(2)结果:本发明洗液高剂量组、中、低剂量组均能明显抑制二甲苯所致小鼠耳廓肿胀,与阴性对照组比较差异有显著性意义,结果见表7。
表7对二甲苯致小鼠耳廓肿胀的影响
组别 | 剂量(%) | 动物数(只) | 肿胀度(mg) | 抑制率(%) |
阴性对照组 | - | 10 | 11.8±3.5 | |
本发明低剂量组 | 5 | 10 | 7.6±2.8 | 35.6 |
本发明中剂量组 | 10 | 10 | 5.2±2.8 | 55.9 |
本发明高剂量组 | 20 | 10 | 3.3±3.2 | 72.0 |
洁尔阴洗液组 | 20 | 10 | 3.7±2.4 | 68.6 |
2.2.3对大鼠实验性阴道炎的影响
(1)模型的建立取大鼠分二组,一组阴道内注入金葡菌(3×10-3个/ml)和大肠杆菌(16×10-3个/ml)的混和液,另一组阴道注入淋球菌液(5×10-2个/ml),均为0.05ml/100g。隔日再接种一次,5d后取阴道分泌物做镜检和生化检查,取混合细菌感染模型(HM)和淋球菌感染模型(LM)大鼠随机分组给药。
(2)对HM和LM大鼠的作用取HM,LM大鼠各50只,随机均分5组本发明洗液低剂量组(4%)、中剂量组(8%)、高剂量组(16%)、阳性药组(洁尔阴洗液16%)和阴性对照组(等体积蒸馏水),连续给药6d。
(3)观察指标及药效评价细菌转阴率停药后d1、d2、d5,分别取阴道分泌物做细菌培养和涂片镜检,3次检查病原体均阴性者为转阴。阴道粘膜停药当天处死大鼠,取阴道标本观察阴道粘膜组织充血、水肿、出血、分泌物量及光滑度0级为无充血、水肿、出血,分泌物正常及阴道粘膜光滑;Ⅰ级为阴道粘膜光滑并伴随轻度充血、水肿,分泌物正常;Ⅱ级为阴道粘膜略光滑,中度充血、水肿并伴点状出血,分泌物增加;Ⅲ级为阴道粘膜不光滑,重度充血、水肿,可见密集出血点,分泌物明显增加,结果见表8。
表8对大鼠阴道细菌感染的疗效
2.3、结论本发明洗液对金黄色葡萄球菌、铜绿假单胞菌、大肠杆菌、乙型链球菌、白色念珠菌和新型念珠菌均有不同程度的抑菌作用。本发明洗液高剂量组中、低剂量组均能明显抑制二甲苯所致小鼠耳廓肿胀。本发明洗液对大鼠实验性阴道炎有很好的治疗作用。此外,从各剂量水平的效果来看,高、中剂量的作用较低剂量显著,说明存在一定量效关系,为该制剂的临床使用提供了依据。
3、毒性实验研究
3.1皮肤急性毒性试验
(1)试验方法取体重(20±2)g小鼠,雌雄各半。参照文献,随机分为5组,每组10只,取本发明洗液给小鼠一次皮下注射给药(试药剂量范围20~160g/kg;给药体积0.1m/10g),连续观察14天内动物毒性反应及死亡情况,并用点斜法计算LD50及LD50的95%可信限。
(2)试验结果取本发明洗液小鼠皮下注射给药,测得其LD50=33.5g/kg,LD50的95%可信限为23g/kg~55g/kg。相当于临床推荐成人外用量0.67g/kg的50倍。本品临床应用为皮肤、粘膜外用剂,吸收至皮下者极少,故可认为本品外用安全低毒。
3.2皮肤长期毒性试验
(1)试验方法取体体重(200±10)g大鼠,雌性。参照文献,设高、中、低3个剂量组,每组动物30只。高、中、低三个剂量浓度分别为120%、80%、40%(该浓度相当于临床推荐用药浓度的60、40、20倍)。本发明洗液给雌性大鼠皮肤、粘膜(大腿内侧、阴道、会阴、肛门周围)涂药,连续涂药30天。
(2)试验结果全部动物健康存活,生长发育和行为活动未见明显异常反应。体重随时间的推移各组均相应增加。血液学、血液生化学检测的各项指标均在正常范围。心、肝、脾、肺、肾、胃、肠、肾上腺、甲状腺、胸腺、子宫、卵巢和涂药部位皮肤、粘膜等重要脏器组织,肉眼观察未见异常,病理组织学检查亦未发现毒性损害。各组间脏器系数差异无显著性意义。停药2周后可逆性观察,未发现迟缓性毒性。
3.3皮肤刺激性实验
(1)试验方法取1.9~2.1kg家兔8只,雌雄各半,随机分为完整和破损皮肤2组,采用同体自身对比法,用赋形剂作对照,观察120%的本发明洗液1ml外用对家兔完整皮肤和破损皮肤的刺激作用。
(2)试验结果本发明洗液对家兔完整皮肤和破损皮肤均无明显刺激性。
3.4粘膜刺激性实验
(1)试验方法取1.9~2.1kg雌性家兔,随机分为受试组与对照组,每组4只分别阴道注入洗液一号和灭菌生理盐水(0.2ml/只/次),每隔1h1次,共计5次。观察其有无全身毒性反应。24h后处死家兔,肉眼和镜检观察阴道粘膜有无充血和水肿等反应。如有死亡则对主要脏器进行病理检查。
(2)试验结果未见全身毒性反应,肉眼观察未发现阴道分泌物、粘膜充血及水肿反应,刺激反应评分均为0,病理组织学观察亦未见异常的病理改变。
3.5主动皮肤过敏实验
(1)试验方法取250~300g豚鼠30只随机分为3组,受试药洗液组、阴性对照(清洁饮用水)组及阳性对照(2、4二硝基氯代苯)组,每组10只,雌雄兼用。进行致敏与激发试验(受试区3X3cm2,受试物量为0.2mL)。按皮肤过敏反应评分标准对皮肤红斑、水肿进行评分。计算致敏反应发生率。按皮肤致敏性评价标准对皮肤致敏性进行评价。
(2)试验结果外用未引起豚鼠皮肤过敏反应。
Claims (4)
1.一种用于治疗女性生殖器炎症的抗菌组合物,其特征在于:所述组合物为龙血竭提取物、重楼提取物、百里香精油、薰衣草精油、美洲大蠊提取物、沙棘油的混合物。
2.根据权利要求1所述的用于治疗女性生殖器炎症的抗菌组合物,其特征是由以下重量百分比的原料组成:龙血竭提取物0.1%—10%、重楼提取物0.1%—10%、百里香精油0.1%—5%、薰衣草精油0.1%—10%、美洲大蠊提取物0.1%—5%、沙棘油0.1%—10%。
3.根据权利要求1或2所述的用于治疗女性生殖器炎症的抗菌组合物,其特征在于:所述抗菌组合物安全有效的载体成分,是满足具体的产品及其剂型要求的载体成分,所述的产品包括药品、个人护理产品、消毒剂及日用品。
4.一种用于治疗女性生殖器炎症的抗菌组合物的用途,其特征在于:所述抗菌组合物用于制备治疗女性生殖器炎症的产品,产品剂型依据具体用途及用法选自:凝胶剂、擦剂、洗剂、喷雾剂。
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CN110772473B (zh) * | 2019-12-09 | 2022-06-07 | 昆明医科大学 | 一种合适于糖尿病病人皮肤的护肤品 |
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