CN112999289A - 一种妇科抑菌凝胶及其制备方法 - Google Patents
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Abstract
本发明公开了一种妇科抑菌凝胶及其制备方法,涉及抑菌凝胶技术领域。其技术要点是:一种妇科抑菌凝胶,包括如下重量份数的组分:植物提取物25‑35份;聚六亚甲基双胍0.15‑0.2份;甘油9‑11份;哈士蟆油9‑11份;玫瑰精油9‑11份;三乙醇胺14‑16份;卡波姆18‑22份;吐温‑80 18‑22份;尼泊金乙酯2.5‑3.5份;纯化水900‑1100份;所述植物提取物的原料包括以下重量分数的组分:苦参90‑110份;黄柏90‑110份;蛇床子90‑110份;五倍子70‑90份;藏红花2.5‑3.5份。本发明具有抑菌效果好的优点。
Description
技术领域
本发明涉及抑菌凝胶技术领域,尤其是涉及一种妇科抑菌凝胶及其制备方法。
背景技术
妇科抑菌凝胶是一种妇科药品,凝胶剂,用于各种妇科阴道炎、宫颈炎的治疗,包括:细菌性阴道炎、滴虫性阴道炎、混合性阴道炎、淋球菌感染、慢性宫颈炎。具有消炎、杀菌、止痒作用。对金黄色葡萄球菌、大肠杆菌、淋球菌、白色念珠球菌、真菌、酵母菌等病原体微生物的生长有明显抑制作用。
在公开号为CN103070881A的中国发明专利中公开了一种阴道抑菌、杀病毒组合物,其特征在于包含聚六亚甲基双胍盐酸盐0.01~3重量份,乙二胺四乙酸二钠0.01~3重量份,甘油0.2~60重量份,羟乙基纤维素0.06~1.8重量份,氯化钾0.015~4.5重量份,乳酸0.02~6重量份。
上述的现有技术方案存在以下缺陷:上述专利属于西药凝胶剂,仅采用聚六亚甲基双胍盐酸盐进行抑菌,聚六亚甲基双胍抑制真菌的效果较差,而其他细菌又容易产生耐药性、易复发,抑菌效果有待提升。
发明内容
针对现有技术存在的不足,本发明的第一个目的在于提供一种妇科抑菌凝胶,其具有抑菌效果好的优点。
本发明的第二个目的在于提供一种妇科抑菌凝胶的制备方法,采用该方法制备的抑菌凝胶具有抑菌效果好的优点。
为实现上述第一个目的,本发明提供了如下技术方案:
一种妇科抑菌凝胶,包括如下重量份数的组分:
植物提取物 25-35份;
聚六亚甲基双胍 0.15-0.2份;
甘油 9-11份;
哈士蟆油 9-11份;
玫瑰精油 9-11份;
三乙醇胺 14-16份;
卡波姆 18-22份;
吐温-80 18-22份;
尼泊金乙酯 2.5-3.5份;
纯化水 900-1100份;
所述植物提取物的原料包括以下重量分数的组分:
苦参 90-110份;
黄柏 90-110份;
蛇床子 90-110份;
五倍子 70-90份;
藏红花 2.5-3.5份。
通过采用上述技术方案,聚六亚甲基双胍具有较好的消毒作用,可以抑制金黄色葡萄球菌、白色念珠菌和大肠杆菌。可用于减轻细菌性、霉菌性、滴虫性、老年性及非特异性阴道炎、宫颈炎、外阴炎、阴部瘙痒等症,清除会阴部异味,减少分泌物。
甘油也叫丙三醇,主要作为溶剂和润滑剂用。
哈士蟆油滋润养阴,降低刺激性,还具有抗氧化作用,防止植物提取物的抑菌活性成分被氧化。
玫瑰精油能调整女性内分泌,滋养子宫,缓解痛经,改善性冷淡和更年期不适。三乙醇胺主要用于调节pH,同时也作为润滑剂、表面活性剂、稳定剂,配合哈士蟆油,降低刺激性。
卡波姆,是以季戊四醇等与丙烯酸交联得到的丙烯酸交联树脂,是流变调节剂和优秀的凝胶基质,起到增稠的作用。
吐温-80可以增加尼泊金乙酯的水溶度,使尼泊金乙酯在溶液中分散的更加均匀,分散均匀的尼泊金乙酯可以对更多的组分发挥作用,充分发挥尼泊金乙酯的作用;同时随着吐温的加入使各个组分分散至不相容的其他不同组分之间,使各组分相互混合均匀,减小分装后的产品之间的效果差异,稳定产品的抑菌效果。
尼泊金乙酯具有较好的防腐作用,对真菌的抑制效果较好,和聚六亚甲基双胍互相补充,还可以减少植物提取物中的有效成分发生变质。
苦参具有清热燥湿,利尿的功效。苦参醚提物及醇提物对金黄色葡萄球菌有较强的抑菌作用;苦参水浸剂对堇色毛癣菌、同心性毛癣菌、许兰毛癣菌、奥杜盎小芽孢癣菌等有抑制作用。
黄柏提取物清热燥湿,泻火解毒,除骨蒸清虚热。用于湿热泻痢,赤白带下,疮疡肿毒,湿疹瘙痒。其抗菌有效成分为小檗碱,对金黄色葡萄球菌、草绿色链球菌、痢疾杆菌、溶血性链球菌、霍乱弧菌、炭疽杆菌均有较强的抑制作用。
研究表明蛇床子含有香豆精类成分蛇床子素、二氢化山芹醇等,有抑制阴道滴虫的作用,对絮状表皮廯菌、流感病毒、新城病毒有抑制作用。苦参与蛇床子配伍,起到了燥湿清热的效果。苦参含有苦参碱、羟基苦参碱等,醇提取物对阴道滴虫、阿米巴原虫有抑制作用。苦参与蛇床子煎剂对结核杆菌、痢疾杆菌、金黄葡萄球菌、大肠杆菌均有抑制作用、对多种皮肤真菌也有抑制作用。
五倍子,有抑菌作用,体外试验表明:五倍子煎剂对金黄色葡萄球菌、乙型溶血性链球菌、肺炎球菌、绿脓杆菌、痢疾杆菌、炭疽杆菌、白喉杆菌、大肠杆菌、伤寒和副伤寒杆菌等均有明显的抑菌作用。经用乙醚提出其鞣酸后的五倍子液仍有抑菌作用,但五倍子心部的煎剂无抗菌作用。
藏红花能够减少患者由于炎症、病菌带来的疼痛感,减少使用者的忧郁不安;藏红花提取物具有活血化瘀,凉血解毒,散郁开结,改善血亏体虚、补血、养血作用。
综上所述,本发明采用植物提取物和抑菌凝胶的其他组分相互结合,同时抑制细菌和真菌,抑菌效果好,而且不易产生耐药性。
本发明在一较佳示例中可以进一步配置为:所述植物提取物的原料还包括10-20份的五叶地锦。
通过采用上述技术方案,五叶地锦含有抑制金黄色葡糖球菌、表皮葡萄球菌等细菌的有效成分,例如,萜烯、酚酸、醚类、乙醛。
本发明在一较佳示例中可以进一步配置为:所述植物提取物的原料还包括6-10份的虎杖。
通过采用上述技术方案,虎杖对金黄色葡萄球菌、枯草芽孢杆菌、大肠杆菌等细菌具有明显的抑制作用,配合尼泊金乙酯以及对真菌有抑制作用的植物提取物,协同增效,提高抑菌效果。
本发明在一较佳示例中可以进一步配置为:所述妇科抑菌凝胶还包括6-8份的阴香叶精油。
通过采用上述技术方案,阴香叶精油对白色念珠菌具有较强的抑菌效果,可以弥补聚六亚甲基双胍的缺点,而且与尼泊金乙酯复配,进一步增强抑菌效果。
本发明在一较佳示例中可以进一步配置为:所述妇科抑菌凝胶还包括2-5份的侧枝匍灯藓提取液。
通过采用上述技术方案,侧枝匍灯藓提取液对金葡菌、藤黄八叠球菌、白色念珠菌、巨大芽孢杆菌和啤酒酵母菌具有明显的抑制作用,与其他抑菌成分配合,扩宽抑菌凝胶的抑菌谱。
本发明在一较佳示例中可以进一步配置为:所述侧枝匍灯藓提取液的制备方法包括以下步骤:采集新鲜的侧枝匍灯藓,用自来水冲洗后再用蒸馏水清洗干净,晾干后送入烘箱内烘干,烘箱的温度不超过45℃,将烘干后的侧枝匍灯藓粉碎得到粉末,将粉末放入烧杯中,注入体积浓度为80%的乙醇,室温下超声波振动提取至少12小时,离心至少15min,收集提取液,滤渣再用体积浓度为80%的乙醇重复提取至少两次,合并提取液,得到侧枝匍灯藓提取液。
通过采用上述技术方案,控制烘箱的温度,在保证烘干效率的前提下,避免抑菌成分失活,粉碎成粉末是为了加快提取速度,采用乙醇多次超声波提取,能够充分提取有效成分,提高抑菌效果。
本发明在一较佳示例中可以进一步配置为:所述妇科抑菌凝胶还包括3-5份的丁二醇。
通过采用上述技术方案,由于植物提取物中的含氨基官能团,与卡波姆能形成水溶性的络合物,丁二醇可以调节液体的溶解度参数来防止产生络合物,同时丁二醇起到保湿、降低黏腻感的作用。
为实现上述第二个目的,本发明提供了如下技术方案:
一种妇科抑菌凝胶的制备方法,包括以下步骤:
步骤一,取相应重量份数的苦参、黄柏、蛇床子、五倍子、藏红花,加入纯化水煎煮两次,过滤,除去滤渣,合并两次滤液,加热浓缩至60℃下相对密度为1.1-1.2的浸膏,加入乙醇使乙醇体积浓度达到75%,搅拌均匀,醇沉,静置至少24小时,取上清液,回收上清液中的乙醇至乙醇的体积浓度小于1%,得到植物提取液;
步骤二,取尼泊金乙酯,用乙醇溶解,得到尼泊金乙酯溶液;
步骤三,取卡波姆,加入纯化水浸泡至少24小时,得到凝胶基质;
步骤四,将尼泊金乙酯溶液、植物提取液加入凝胶基质中,再加入聚六亚甲基双胍、甘油、哈士蟆油、玫瑰精油、吐温-80,搅拌均匀,加入剩余的纯化水稀释,滴入三乙醇胺调节pH至7,搅拌均匀,得到妇科抑菌凝胶。
通过采用上述技术方案,先对植物原料进行提取得到植物提取液,尼泊金乙酯用乙醇溶解后更容易分散,吐温-80可以增加尼泊金乙酯的水溶度,使尼泊金乙酯在溶液中分散的更加均匀,还可以促进水相成分和油相成分分散、混合均匀,三乙醇胺调节pH至7,降低了抑菌凝胶的刺激性。
本发明在一较佳示例中可以进一步配置为:所述步骤一具体包括:取相应重量份数的苦参、黄柏、蛇床子、五倍子、藏红花,再取五叶地锦和虎杖,加入纯化水煎煮两次,过滤,除去滤渣,合并两次滤液,加热浓缩至60℃下相对密度为1.1-1.2的浸膏,加入乙醇使乙醇体积浓度达到75%,搅拌均匀,醇沉,静置至少24小时,取上清液,回收上清液中的乙醇至乙醇的体积浓度小于1%,得到植物提取液。
通过采用上述技术方案,五叶地锦含有抑制金黄色葡糖球菌、表皮葡萄球菌等细菌的有效成分,例如,萜烯、酚酸、醚类、乙醛。虎杖对金黄色葡萄球菌、枯草芽孢杆菌、大肠杆菌等细菌具有明显的抑制作用,配合尼泊金乙酯以及对真菌有抑制作用的植物提取物,协同增效,提高抑菌效果。
本发明在一较佳示例中可以进一步配置为:所述步骤四具体包括:将尼泊金乙酯溶液、植物提取液加入凝胶基质中,再加入阴香叶精油、侧枝匍灯藓提取液和丁二醇,再加入聚六亚甲基双胍、甘油、哈士蟆油、玫瑰精油、吐温-80,搅拌均匀,加入剩余的纯化水稀释,滴入三乙醇胺调节pH至7,搅拌均匀,得到妇科抑菌凝胶。
通过采用上述技术方案,阴香叶精油对白色念珠菌具有较强的抑菌效果,可以弥补聚六亚甲基双胍的缺点,而且与尼泊金乙酯复配,进一步增强抑菌效果。侧枝匍灯藓提取液对金葡菌、藤黄八叠球菌、白色念珠菌、巨大芽孢杆菌和啤酒酵母菌具有明显的抑制作用,与其他抑菌成分配合,扩宽抑菌凝胶的抑菌谱。丁二醇可以调节液体的溶解度参数来防止卡波姆与氨基结合产生络合物,同时起到保湿、降低黏腻感的作用。
综上所述,本发明包括以下至少一种有益技术效果:
1.本发明中的尼泊金乙酯具有较好的防腐作用,对真菌的抑制效果较好,和聚六亚甲基双胍互相补充,还可以减少植物提取物中的有效成分发生变质,哈士蟆油滋润养阴,还可以防止植物提取物的活性成分被氧化,采用植物提取物和抑菌凝胶的其他组分相互结合,同时抑制细菌和真菌,抑菌效果好,而且不易产生耐药性。
2.本发明中的五叶地锦含有抑制金黄色葡糖球菌、表皮葡萄球菌等细菌的有效成分,例如,萜烯、酚酸、醚类、乙醛。虎杖对金黄色葡萄球菌、枯草芽孢杆菌、大肠杆菌等细菌具有明显的抑制作用,配合尼泊金乙酯以及对真菌有抑制作用的植物提取物,协同增效,提高抑菌效果。
3.本发明中的阴香叶精油对白色念珠菌具有较强的抑菌和杀菌效果,可以弥补聚六亚甲基双胍的缺点,而且与尼泊金乙酯复配,进一步增强抑菌效果。侧枝匍灯藓提取液对金葡菌、藤黄八叠球菌、白色念珠菌、巨大芽孢杆菌和啤酒酵母菌具有明显的抑制作用,与其他抑菌成分配合,扩宽抑菌凝胶的抑菌谱。
具体实施方式
下面结合实施例,对本发明进行详细描述。
实施例1:一种妇科抑菌凝胶,各组分及其相应的重量份数如表1和表2所示,并通过如下步骤制备获得:
步骤一,取相应重量份数的苦参、黄柏、蛇床子、五倍子、藏红花,加入纯化水煎煮两次,第一次加入8倍的纯化水,煎煮1.5h,第二次加入6倍的纯化水,煎煮1h,过滤,除去滤渣,合并两次滤液,加热浓缩至60℃下相对密度为1.1-1.2的浸膏,加入乙醇使乙醇体积浓度达到75%,搅拌均匀,醇沉,静置至少24小时,本实施例中静置24小时,取上清液,回收上清液中的乙醇至乙醇的体积浓度小于1%,得到植物提取液;
步骤二,取尼泊金乙酯,用乙醇溶解,得到尼泊金乙酯溶液;
步骤三,取卡波姆,加入纯化水浸泡至少24小时,本实施例中浸泡24小时,得到凝胶基质;
步骤四,将尼泊金乙酯溶液、植物提取液加入凝胶基质中,再加入聚六亚甲基双胍、甘油、哈士蟆油、玫瑰精油、吐温-80,搅拌均匀,加入剩余的纯化水稀释,滴入三乙醇胺调节pH至7,搅拌均匀,得到妇科抑菌凝胶。
实施例2-5:一种妇科抑菌凝胶,与实施例1的不同之处在于,各组分及其相应的重量份数如表1和表2所示。
表1实施例1-5中各组分及其重量份数
表2实施例1-5中植物提取物的原料的各组分及其重量份数
实施例6-11:一种妇科抑菌凝胶,与实施例1的不同之处在于,各组分及其相应的重量份数如表3所示。
其中,实施例6-8中的步骤一具体包括:取相应重量份数的苦参、黄柏、蛇床子、五倍子、藏红花,再取五叶地锦,加入纯化水煎煮两次,过滤,出去滤渣,合并两次滤液,加热浓缩至60℃下相对密度为1.1-1.2的浸膏,加入乙醇使乙醇体积浓度达到75%,搅拌均匀,醇沉,静置至少24小时,取上清液,回收上清液中的乙醇至乙醇的体积浓度小于1%,得到植物提取液。
实施例9-11中的步骤一具体包括:取相应重量份数的苦参、黄柏、蛇床子、五倍子、藏红花,再取虎杖,加入纯化水煎煮两次,过滤,出去滤渣,合并两次滤液,加热浓缩至60℃下相对密度为1.1-1.2的浸膏,加入乙醇使乙醇体积浓度达到75%,搅拌均匀,醇沉,静置至少24小时,取上清液,回收上清液中的乙醇至乙醇的体积浓度小于1%,得到植物提取液。
表3实施例6-11中植物提取物的原料的各组分及其重量份数
实施例12:一种妇科抑菌凝胶,与实施例1的不同之处在于,妇科抑菌凝胶还包括6份的阴香叶精油,步骤四具体包括:将尼泊金乙酯溶液、植物提取液加入凝胶基质中,再加入阴香叶精油,再加入聚六亚甲基双胍、甘油、哈士蟆油、玫瑰精油、吐温-80,搅拌均匀,加入剩余的纯化水稀释,滴入三乙醇胺调节pH至7,搅拌均匀,得到妇科抑菌凝胶。
实施例13:一种妇科抑菌凝胶,与实施例12的不同之处在于,妇科抑菌凝胶还包括8份的阴香叶精油。
实施例14:一种妇科抑菌凝胶,与实施例12的不同之处在于,妇科抑菌凝胶还包括10份的阴香叶精油。
实施例15:一种妇科抑菌凝胶,与实施例1的不同之处在于,妇科抑菌凝胶还包括2份的侧枝匍灯藓提取液。侧枝匍灯藓提取液的制备方法包括以下步骤:采集新鲜的侧枝匍灯藓,用自来水冲洗后再用蒸馏水清洗干净,晾干后送入烘箱内烘干,烘箱的温度不超过45℃,将烘干后的侧枝匍灯藓粉碎得到粉末,将粉末放入烧杯中,注入体积浓度为80%的乙醇,室温下超声波振动提取至少12小时,离心至少15min,收集提取液,滤渣再用体积浓度为80%的乙醇重复提取至少两次,合并提取液,得到侧枝匍灯藓提取液。
步骤四具体包括:将尼泊金乙酯溶液、植物提取液加入凝胶基质中,再加入侧枝匍灯藓提取液,再加入聚六亚甲基双胍、甘油、哈士蟆油、玫瑰精油、吐温-80,搅拌均匀,加入剩余的纯化水稀释,滴入三乙醇胺调节pH至7,搅拌均匀,得到妇科抑菌凝胶。
实施例16:一种妇科抑菌凝胶,与实施例15的不同之处在于,妇科抑菌凝胶还包括3.5份的侧枝匍灯藓提取液。
实施例17:一种妇科抑菌凝胶,与实施例15的不同之处在于,妇科抑菌凝胶还包括5份的侧枝匍灯藓提取液。
实施例18:一种妇科抑菌凝胶,与实施例1的不同之处在于,妇科抑菌凝胶还包括3份的丁二醇,步骤四具体包括:将尼泊金乙酯溶液、植物提取液加入凝胶基质中,再加入丁二醇,再加入聚六亚甲基双胍、甘油、哈士蟆油、玫瑰精油、吐温-80,搅拌均匀,加入剩余的纯化水稀释,滴入三乙醇胺调节pH至7,搅拌均匀,得到妇科抑菌凝胶。
实施例19:一种妇科抑菌凝胶,与实施例18的不同之处在于,妇科抑菌凝胶还包括4份的丁二醇。
实施例20:一种妇科抑菌凝胶,与实施例18的不同之处在于,妇科抑菌凝胶还包括5份的丁二醇。
实施例21:一种妇科抑菌凝胶,与实施例7的不同之处在于,植物提取物的原料还包括8份的虎杖,步骤一具体包括:取相应重量份数的苦参、黄柏、蛇床子、五倍子、藏红花,再取五叶地锦和虎杖,加入纯化水煎煮两次,过滤,出去滤渣,合并两次滤液,加热浓缩至60℃下相对密度为1.1-1.2的浸膏,加入乙醇使乙醇体积浓度达到75%,搅拌均匀,醇沉,静置至少24小时,取上清液,回收上清液中的乙醇至乙醇的体积浓度小于1%,得到植物提取液。
实施例22:一种妇科抑菌凝胶,与实施例21的不同之处在于,妇科抑菌凝胶还包括8份的阴香叶精油、3.5份的侧枝匍灯藓提取液、4份的丁二醇,步骤四具体包括:将尼泊金乙酯溶液、植物提取液加入凝胶基质中,再加入阴香叶精油、侧枝匍灯藓提取液和丁二醇,再加入聚六亚甲基双胍、甘油、哈士蟆油、玫瑰精油、吐温-80,搅拌均匀,加入剩余的纯化水稀释,滴入三乙醇胺调节pH至7,搅拌均匀,得到妇科抑菌凝胶。
对比例1:一种妇科抑菌凝胶,包括如实施例1所述的植物提取物和卡波姆,制备方法为:取卡波姆,加入纯化水浸泡24小时,得到凝胶基质,加入植物提取物,搅拌均匀即可。
对比例2:一种妇科抑菌凝胶,与实施例1的不同之处在于,未加入植物提取物。
对比例3:一种妇科抑菌凝胶,与实施例1的不同之处在于,未加入哈士蟆油。
对比例4:一种妇科抑菌凝胶,与实施例1的不同之处在于,仅加入0.5份的哈士蟆油。
对比例5:一种妇科抑菌凝胶,与实施例1的不同之处在于,加入15份的哈士蟆油。
对比例6:一种妇科抑菌凝胶,与对比例2的不同之处在于,不加尼泊金乙酯。
对比例7:一种妇科抑菌凝胶,与对比例2的不同之处在于,仅加入0.5份尼泊金乙酯。
对比例8:一种妇科抑菌凝胶,与对比例2的不同之处在于,加入5份尼泊金乙酯。
试验一、抑菌试验测试
试验样品:采用实施例1-21中获得的妇科用抑菌洗液作为试验样品1-21,采用对比例1-23中获得的妇科用抑菌洗液作为对照样品1-23。
(一)器材
1、试验菌株:大肠杆菌培养9代、白色念珠菌培养9代、金黄色葡萄球菌培养9代,由中国菌种保藏中心提供;
2、普通营养琼脂培养基,由北京路桥技术有限责任公司提供;
3、0.03摩尔/升磷酸盐缓冲溶液;
4、载体:滤纸片、无菌刻度吸管、无菌平皿、无菌试管、恒温培养箱等。
(二)样品处理
称取5g样品,放入无菌研钵中研磨、粉碎、混匀,放入无菌平皿中直接进行抑菌试验。
(三)方法
1、依据GB15979-2002《一次性使用卫生用品卫生标准》附录C4、《消毒技术规范》2002版2.1.8进行;
2、抑菌试验为载体试验。试验温度20±1℃,试验重复三次,记录5分钟时的抑菌率,取平均值。
注:阳性对照组平均生长菌落数为2.14*104cfu/片,阴性对照组无菌生长。
试验结果分析:将实施例1、对比例1-2的结果进行对比,实施例1的平均抑菌率明显高于对比例1和对比例2之和,说明苦参、黄柏、蛇床子、五倍子、藏红花的植物提取物和对比例2的组分相配合,协同增效,能够显著提升抑菌凝胶的抑菌率。
将实施例1、对比例3-5的结果进行对比,对比例3未加入哈士蟆油,平均抑菌率下降了5%左右,在加入0.5份哈士蟆油后,平均抑菌率上升了1%左右,在加入15份哈士蟆油后,平均抑菌率并没有显著提升,说明哈士蟆油能够防止植物提取物的抑菌活性成分被氧化,从而提升抑菌凝胶的抑菌率,加入的哈士蟆油太少,起不到较好的抑菌作用,加入的哈士蟆油太多,抑菌率没有明显提升,造成浪费。
将对比例2、对比例6-8的结果进行对比,对比例6未加入尼泊金乙酯,平均抑菌率下降了5%左右,在加入0.5份尼泊金乙酯后,平均抑菌率上升了2%左右,在加入5份尼泊金乙酯后,平均抑菌率并没有显著提升,造成浪费,说明尼泊金乙酯与聚六亚甲基双胍复配,可以协同增效。
表4抑菌试验测试结果
试验二、阴道粘膜刺激性试验测试
(一)材料和方法
1、试验动物:由西安交通大学医学院实验动物中心提供日本大耳白家兔,雌性,体重2.0-2.5kg,一级动物;
2、动物室环境:温度:22-25℃,相对湿度:45-55%。
(二)阴道粘膜刺激性验方法
1、试验依据:卫生部2002年版《消毒技术规范》中的方法进行试验;
2、受试物剂量:2g/只;
3、试验方法:试验时动物仰卧固定,受试物组经阴道注入受试物2g/只,对照组给予同容积生理盐水,动物仰卧固定4小时,使受试物与阴道粘膜充分接触。试验结束后动物放回笼内饲养,24小时后处死动物取出阴道组织,肉眼仔细观察粘膜变性、分泌物、血管充血、水肿等现象,以注入生理盐水动物的粘膜变性、分泌物、血管充血、水肿状况计0分,其余动物与注入生理盐水动物做对比打分,分值0-5分,分值越大表示受损越严重。
试验结果:阴道粘膜刺激性的测试结果如表5所示,根据表5可知,实施例1-22对阴道粘膜均没有刺激性,对比例1仅加入植物提取物,会有轻微的刺激性,说明玫瑰精油和哈士蟆油可以降低刺激性,对比例2未加入植物提取物,说明植物提取物的活性成分更佳天然,但单独使用难免会含有轻微刺激性的杂质,植物提取物与对比例2中的成分配合使用,可以降低刺激性,对比例3未加入哈士蟆油,有轻微的刺激性,说明哈士蟆油可以降低对阴道粘膜的刺激性。
表5阴道粘膜刺激性的测试结果
本具体实施方式的实施例均为本发明的较佳实施例,并非依此限制本发明的保护范围,故:凡依本发明的结构、形状、原理所做的等效变化,均应涵盖于本发明的保护范围之内。
Claims (10)
1.一种妇科抑菌凝胶,其特征在于,包括如下重量份数的组分:
植物提取物25-35份;
聚六亚甲基双胍0.15 -0.2份;
甘油9-11份;
哈士蟆油9-11份;
玫瑰精油9-11份;
三乙醇胺14-16份;
卡波姆18-22份;
吐温-80 18-22份;
尼泊金乙酯2.5-3.5份;
纯化水900-1100份;
所述植物提取物的原料包括以下重量分数的组分:
苦参90-110份;
黄柏90-110份;
蛇床子90-110份;
五倍子70-90份;
藏红花2.5-3.5份。
2.根据权利要求1所述的妇科抑菌凝胶,其特征在于,所述植物提取物的原料还包括10-20份的五叶地锦。
3.根据权利要求1所述的妇科抑菌凝胶,其特征在于,所述植物提取物的原料还包括6-10份的虎杖。
4.根据权利要求1所述的妇科抑菌凝胶,其特征在于,所述妇科抑菌凝胶还包括6-8份的阴香叶精油。
5.根据权利要求1所述的妇科抑菌凝胶,其特征在于,所述妇科抑菌凝胶还包括2-5份的侧枝匍灯藓提取液。
6.根据权利要求5所述的妇科抑菌凝胶,其特征在于,所述侧枝匍灯藓提取液的制备方法包括以下步骤:采集新鲜的侧枝匍灯藓,用自来水冲洗后再用蒸馏水清洗干净,晾干后送入烘箱内烘干,烘箱的温度不超过45℃,将烘干后的侧枝匍灯藓粉碎得到粉末,将粉末放入烧杯中,注入体积浓度为80%的乙醇,室温下超声波振动提取至少12小时,离心至少15min,收集提取液,滤渣再用体积浓度为80%的乙醇重复提取至少两次,合并提取液,得到侧枝匍灯藓提取液。
7.根据权利要求1所述的妇科抑菌凝胶,其特征在于,所述妇科抑菌凝胶还包括3-5份的丁二醇。
8.一种妇科抑菌凝胶的制备方法,其特征在于,包括以下步骤:
步骤一,取相应重量份数的苦参、黄柏、蛇床子、五倍子、藏红花,加入纯化水煎煮两次,过滤,除去滤渣,合并两次滤液,加热浓缩至60℃下相对密度为1.1-1.2的浸膏,加入乙醇使乙醇体积浓度达到75%,搅拌均匀,醇沉,静置至少24小时,取上清液,回收上清液中的乙醇至乙醇的体积浓度小于1%,得到植物提取液;
步骤二,取尼泊金乙酯,用乙醇溶解,得到尼泊金乙酯溶液;
步骤三,取卡波姆,加入纯化水浸泡至少24小时,得到凝胶基质;
步骤四,将尼泊金乙酯溶液、植物提取液加入凝胶基质中,再加入聚六亚甲基双胍、甘油、哈士蟆油、玫瑰精油、吐温-80,搅拌均匀,加入剩余的纯化水稀释,滴入三乙醇胺调节pH至7,搅拌均匀,得到妇科抑菌凝胶。
9.根据权利要求8所述的妇科抑菌凝胶的制备方法,其特征在于,所述步骤一具体包括:取相应重量份数的苦参、黄柏、蛇床子、五倍子、藏红花,再取五叶地锦和虎杖,加入纯化水煎煮两次,过滤,除去滤渣,合并两次滤液,加热浓缩至60℃下相对密度为1.1-1.2的浸膏,加入乙醇使乙醇体积浓度达到75%,搅拌均匀,醇沉,静置至少24小时,取上清液,回收上清液中的乙醇至乙醇的体积浓度小于1%,得到植物提取液。
10.据权利要求9所述的妇科抑菌凝胶的制备方法,其特征在于,所述步骤四具体包括:将尼泊金乙酯溶液、植物提取液加入凝胶基质中,再加入阴香叶精油、侧枝匍灯藓提取液和丁二醇,再加入聚六亚甲基双胍、甘油、哈士蟆油、玫瑰精油、吐温-80,搅拌均匀,加入剩余的纯化水稀释,滴入三乙醇胺调节pH至7,搅拌均匀,得到妇科抑菌凝胶。
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