CN111743986A - 一种妇科凝胶及其制备方法 - Google Patents
一种妇科凝胶及其制备方法 Download PDFInfo
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- CN111743986A CN111743986A CN202010649412.3A CN202010649412A CN111743986A CN 111743986 A CN111743986 A CN 111743986A CN 202010649412 A CN202010649412 A CN 202010649412A CN 111743986 A CN111743986 A CN 111743986A
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Abstract
本发明涉及女性卫生健康用日化用品技术领域,具体涉及一种妇科凝胶及其制备方法。一种妇科凝胶,按重量份计,至少包括以下组分:植物活性物质20‑50份、角鲨烯10‑30份、小分子醇5‑20份、氨基酸衍生物3‑8份、维生素1‑5份、保湿剂1‑5份、增稠剂0.5‑3份、pH调节剂0.5‑3份、水30‑50份。本发明提供了一种妇科凝胶,具有增强阴道环境免疫系统功能、抑菌、祛除阴道异味以及活化细胞的作用,还具有改善阴部的松弛状态和女性患者的心理状态,提高阴部肌肤的滋润度、缓解精神焦虑,平和内心的功效。
Description
技术领域
本发明涉及女性卫生健康用日化用品技术领域,具体涉及一种妇科凝胶及其制备方法。
背景技术
由于女性特有的生理结构和体质,加之竞争压力增大、工作生活节奏加快等各种因素,近年来妇科疾病的发病率普遍较高,不断威胁女性健康,其中阴道炎、宫颈糜烂、乳腺癌等是最常见的妇科疾病,妇科疾病已经成为女性的头号“杀手”。针对外阴瘙痒、阴道炎、宫颈炎等常见妇科问题,需要加强日常的卫生护理、预防保养等。妇科炎症,包括阴道炎、宫颈炎等,是由于外部损伤或感染,导致病原体细菌侵袭而形成的炎症。对目前治疗妇科疾病的要去分为内服药和外用药。内服药一种药为主,剂型包括将囊、滴丸等;外用药则以化学药品为主,剂型以内置的栓剂、片剂居多。妇科用化学药品过多食用容易破坏引道菌群间关系,导致耐药性等不良作用。栓剂、片剂食用不方便,易造成阴道损伤,且栓剂易流出,污染衣物。理想的妇科外用产品应具有良好的抑菌消炎、安全性、生物相容性等,同时要稳定性好、易于贮存、使用方便,与滴丸、栓剂、片剂相比,凝胶剂外观光滑、透明细腻、无刺激性,不妨碍皮肤的正常功能,且稠度、粘度适宜,易于涂布使用,携带、使用、贮藏、运输极为方便,稳定性好。
目前市面上,预防及治疗妇科炎症药物较多,但存在以下问题:疗效较为单一;针对妇科炎症的药物对患者生殖道环境以及黏膜自身分泌功能产生一定程度上的破坏,局部免疫力下降,致病菌产生耐药性,使得炎症反复发作;药物稳定性较差,作用时间短,疗效较慢。如何解决上述技术不足,成为亟待解决的问题。
因此,针对上述问题,本发明提供了一种妇科凝胶,能够杀菌祛湿、对各类炎症的治疗效果优异,提高阴部肌肤滋润度、快速去除阴部异味、改善阴部的松弛状态、缓解愤怒和焦虑,安抚神经、增加舒适感。
发明内容
为了解决上述技术问题,本发明的第一个方面提供了一种妇科凝胶,所述妇科凝胶的制备原料,按重量份计,至少包括以下组分:植物活性物质20-50份、角鲨烯10-30份、小分子醇5-20份、氨基酸衍生物3-8份、维生素1-5份、保湿剂1-5份、增稠剂0.5-3份、pH调节剂0.5-3份、水30-50份。
作为本发明一种优选的技术方案,所述植物活性物质为植物提取物和植物精油的组合,重量比为1:(1-10)。
作为本发明一种优选的技术方案,所述植物提取物包括紫苏提取物、艾叶提取物、天竺葵提取物、当归提取物、益母草提取物、玛咖提取物、迷迭香提取物和熊果苷提取物中的至少一种。
作为本发明一种优选的技术方案,所述植物提取物为紫苏提取物、益母草提取物、迷迭香提取物和熊果苷提取物的组合,重量比为1:(1-2):(0.5-1.5):(0.1-0.5)。
作为本发明一种优选的技术方案,所述植物精油包括玫瑰精油、依兰精油、橙花精油、豆蔻精油、苦参精油、天竺葵精油、柠檬精油、广藿香精油中的至少一种。
作为本发明一种优选的技术方案,所述植物精油为依兰精油和苦参精油的组合,重量比为1:(1-5)。
作为本发明一种优选的技术方案,所述植物提取物和角鲨烯的重量比为(1-5):1。
作为本发明一种优选的技术方案,所述妇科凝胶的制备原料还包括海藻酸盐;所述氨基酸衍生物和海藻酸盐的重量比为1:(0.05-0.5)。
作为本发明一种优选的技术方案,所述小分子醇为C2-C4的小分子醇,选自丙二醇,乙醇、丙三醇、丁醇中的至少一种。
本发明的第二个方面提供了所述妇科凝胶的制备方法,至少包括以下步骤:将水加热至20-40℃,边搅拌边加入维生素、氨基酸衍生物和小分子醇,搅拌10-60分钟后升温至30-60℃;然后加入植物活性物质、角鲨烯、保湿剂、增稠剂、pH调节剂以及剩余原料,搅拌30-80分钟,即得。
有益效果
本发明提供了一种妇科凝胶,具有增强阴道环境免疫系统功能、抑菌、祛除阴道异味以及活化细胞的作用,还具有改善阴部的松弛状态和女性患者的心理状态,提高阴部肌肤的滋润度、缓解精神焦虑,平和内心的功效。
具体实施方式
参选以下本发明的优选实施方法的详述以及包括的实施例可更容易地理解本发明的内容。除非另有限定,本文使用的所有技术以及科学术语具有与本发明所属领域普通技术人员通常理解的相同的含义。当存在矛盾时,以本说明书中的定义为准。
如本文所用术语“由…制备”与“包含”同义。本文中所用的术语“包含”、“包括”、“具有”、“含有”或其任何其它变形,意在覆盖非排它性的包括。例如,包含所列要素的组合物、步骤、方法、制品或装置不必仅限于那些要素,而是可以包括未明确列出的其它要素或此种组合物、步骤、方法、制品或装置所固有的要素。
连接词“由…组成”排除任何未指出的要素、步骤或组分。如果用于权利要求中,此短语将使权利要求为封闭式,使其不包含除那些描述的材料以外的材料,但与其相关的常规杂质除外。当短语“由…组成”出现在权利要求主体的子句中而不是紧接在主题之后时,其仅限定在该子句中描述的要素;其它要素并不被排除在作为整体的所述权利要求之外。
当量、浓度、或者其它值或参数以范围、优选范围、或一系列上限优选值和下限优选值限定的范围表示时,这应当被理解为具体公开了由任何范围上限或优选值与任何范围下限或优选值的任一配对所形成的所有范围,而不论该范围是否单独公开了。例如,当公开了范围“1至5”时,所描述的范围应被解释为包括范围“1至4”、“1至3”、“1至2”、“1至2和4至5”、“1至3和5”等。当数值范围在本文中被描述时,除非另外说明,否则该范围意图包括其端值和在该范围内的所有整数和分数。
单数形式包括复数讨论对象,除非上下文中另外清楚地指明。“任选的”或者“任意一种”是指其后描述的事项或事件可以发生或不发生,而且该描述包括事件发生的情形和事件不发生的情形。
说明书和权利要求书中的近似用语用来修饰数量,表示本发明并不限定于该具体数量,还包括与该数量接近的可接受的而不会导致相关基本功能的改变的修正的部分。相应的,用“大约”、“约”等修饰一个数值,意为本发明不限于该精确数值。在某些例子中,近似用语可能对应于测量数值的仪器的精度。在本申请说明书和权利要求书中,范围限定可以组合和/或互换,如果没有另外说明这些范围包括其间所含有的所有子范围。
此外,本发明要素或组分前的不定冠词“一种”和“一个”对要素或组分的数量要求(即出现次数)无限制性。因此“一个”或“一种”应被解读为包括一个或至少一个,并且单数形式的要素或组分也包括复数形式,除非所述数量明显旨指单数形式。
为了解决上述技术问题,本发明的第一个方面提供了一种妇科凝胶,所述妇科凝胶的制备原料,按重量份计,至少包括以下组分:植物活性物质20-50份、角鲨烯10-30份、小分子醇5-20份、氨基酸衍生物3-8份、维生素1-5份、保湿剂1-5份、增稠剂0.5-3份、pH调节剂0.5-3份、水30-50份。
在一种优选的实施方式中,所述妇科凝胶的制备原料,按重量份计,包括以下组分:植物活性物质40份、角鲨烯20份、小分子醇10份、氨基酸衍生物4份、维生素2份、保湿剂3份、增稠剂2份、pH调节剂2份、水40份。
植物活性物质
本发明中,所述植物活性物质为植物提取物和植物精油的组合。
在一种优选的实施方式中,所述植物提取物和植物精油的重量比为1:(1-10)。
在一种更优选的实施方式中,所述植物提取物和植物精油的重量比为1:5。
植物提取物
植物提取物(Plant extracts)指采用适当的溶剂或方法,从植物(植物全部或者某一部分)为原料提取或加工而成的物质,可用于医药行业、食品行业、健康行业、美容行业以及其它行业。植物提取物是以植物为原料,按照对提取的最终产品的用途的需要,经过物理化学提取分离过程,定向获取和浓集植物中的某一种或多种有效成分,而不改变其有效成分结构而形成的产品。按照提取植物的成份不同,形成甙、酸、多酚、多糖、萜类、黄酮、生物碱等;按照性状不同,可分为植物油、浸膏、粉、晶状体等。
本发明中,所述植物提取物包括紫苏提取物、艾叶提取物、天竺葵提取物、当归提取物、益母草提取物、玛咖提取物、迷迭香提取物和熊果苷提取物中的至少一种。
在一种优选的实施方式中,所述植物提取物为紫苏提取物、益母草提取物、迷迭香提取物和熊果苷提取物的组合,重量比为1:(1-2):(0.5-1.5):(0.1-0.5)。
在一种更优选的实施方式中,所述紫苏提取物、益母草提取物、迷迭香提取物和熊果苷提取物的重量比为1:1.5:1:0.3。
紫苏提取物
紫苏提取物植物来源为唇形科紫苏属植物紫苏Perillafrutescens(L.)Britt.的茎、叶。其叶称为紫苏叶,其茎称为紫苏梗,紫苏叶片多皱缩卷曲、破碎,边缘具圆锯齿。两面紫色,或上表面绿色、下表面紫色,疏生灰白色毛,下表面有多数凹点状的腺鳞。叶柄长2-7cm,紫色或紫绿色。嫩枝直径2-5mm,紫绿色,断面中部有髓。气清香,味微辛。
本发明中,所述紫苏提取物的来源,没有特别的限制,可提及扶风斯诺特生物科技有限公司。
益母草提取物
益母草提取物为唇形科植物益母草Leonurusheterophyllus Sweet的地上部分,具有活血调经、祛瘀生新、利尿消肿、清热解毒的功能。益母草含有多种微量元素。硒具有增强免疫细胞活力、缓和动脉粥样硬化之发生以及提高肌体防御疾病功能体系之作用;锰能抗氧化、防衰老、抗疲劳及抑制癌细胞的增生。所以,益母草能益颜美容,抗衰防老。益母草水浸液(1:4)在试管内对许兰黄癣菌、羊毛状小芽胞癣菌、红色表皮癣菌、星形奴卡菌等皮肤致病性真菌,均有不同程度的抑制作用。
本发明中,所述益母草提取物的来源,没有特别的限制,可提及陕西华实生物科技有限公司。
迷迭香提取物
迷迭香提取物主要包括鼠尾草酚、迷迭香二醛、表迷迭香酚、表迷迭香酚甲醚、鼠尾草酸、鼠尾草酸甲酯、迷迭香酚、熊果酸、齐墩果酸等萜类物质,芹菜素、橙皮素、高车前苷、芫花素等黄酮类物质,香草酸、咖啡酸、迷迭香酸、阿魏酸等酚酸类物质以及含有α-蒎烯、三环萜、对伞花烃、柠檬烯、1,8-桉叶油素、龙脑、樟脑、α-松油醇、β-松油醇、松油烯-4-醇等成分的迷迭香精油。迷迭香提取物具有高效、安全等特性,广泛应用于化妆品、香水、香皂、空气清新剂驱虫剂、医药各种动植物油脂、动物饲料、肉制品、海产品、面粉、调味酱、调味料、烘焙食品、油炸产品、天然色素、香精、生物农药、烟草等领域,特别是可以治疗血液恶性肿瘤、心血管病、抗癌、抑制艾滋病毒的感染、治疗消化不良、预防老年痴呆症、心脏病、高尿酸血症以及呼吸系统的疾病等,为生产、生活带来了许多方便。
本发明中,所述迷迭香提取物的来源,没有特别的限制,可提及安徽宏通生物工程有限公司。
熊果苷提取物
熊果苷又名熊果素,呈白色针状结晶或粉末。萃取自熊果的叶子,能够通过抑制体内酪氨酸酶的活性,阻止黑色素的生成,从而减少皮肤色素沉积,祛除色斑和雀斑,同时还有杀菌、消炎的作用。熊果苷是源于绿色植物的天然活性物质,集“绿色植物、安全可靠”和“高效脱色”三者合谐统一于一体的皮肤脱色组份,它能迅速渗入肌肤,在不影响细胞增殖浓度的同时,能有效地抑制皮肤中的酪氨酸酶的活性,阻断黑色素的形成,通过自身与酪氨酶直接结合,加速黑色素的分解与排泄,从而减少皮肤色素沉积,祛除色斑和雀斑,而且对黑色素细胞不产生毒害性、刺激性、致敏性等副作用,同时还有杀菌、消炎的作用。
本发明中,所述熊果苷提取物的来源,没有特别的限制,可提及西安优硕生物科技有限公司。
植物精油
植物精油是萃取植物特有的芳香物质,取自于草本植物的花、叶、根、树皮、果实、种子、树脂等以蒸馏、压榨方式提炼出来的。由于香熏精油挥发性高,且分子小,很容易被人体吸收,并能迅速渗透人体内器官,将多余的成分排出体外,整个过程只需要几分钟,而植物本身的香味,也直接刺激脑下垂体的分泌,酵素及荷尔蒙分泌等,平衡体内机能,起到美容护肤的作用。植物精油是由一百多种以上的成分所构成,当然有些更高达数百种至上千种成分构成,一般而言植物精油含有醇类、醛类、酸类、酚类、丙酮类、萜烯类。以玫瑰精油为例86%是由三百多种成分组成,14%是由许多微量化合物组成,这两部分的组成比率不同,也会影响味道及疗效。保加利亚玫瑰中含有33-55%的香茅醇,30-40%的牻牛儿醇和橙花醇,16-22%的硬脂脑,1.5-2%的苯乙醇,0.2-2%的倍半萜环状醇,以及一些微量合成物。
本发明中,所述植物精油包括玫瑰精油、依兰精油、橙花精油、豆蔻精油、苦参精油、天竺葵精油、柠檬精油、广藿香精油中的至少一种。
在一种优选的技术方式中,所述植物精油为依兰精油和苦参精油的组合,重量比为1:(1-5)。
在一种更优选的实施方式中,所述植物精油为依兰精油和苦参精油的组合,重量比为1:3。
依兰精油
依兰精油,是一种来自于植物依兰花的萃取物,该物质无色或黄色,流质状、清澈而有奇香且厚重。依兰树形状为小乔木,叶片为椭圆形,花片为狭良型,花朵颜色有黄色、粉红、紫蓝,精油为蒸馏花朵而得,以黄色花朵萃取之淡黄色精油最佳,主要产地为东亚南亚的马来西亚,菲律宾、缅甸及澳洲。
本发明中,所述依兰精油的来源,没有特别的限制,可提及上海滋鑫生物科技有限公司。
苦参精油
苦参(学名:Radix Sophoraeflavescentis)为豆科苦参属的植物。别名:苦骨、地槐、水槐、菟槐、骄槐、野槐或白茎。分布于俄罗斯、日本、印度、朝鲜以及中国大陆的南北各省区等地,生长于海拔1500米的地区,多生在山坡、沙地、草坡、灌木林中及田野附近,目前尚未由人工引种栽培。功能主要功效:清热燥湿,杀虫,利尿。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;外治滴虫性阴道炎等问题。苦参具有抗菌消炎的作用,对痤疮杆菌、金黄色葡萄球菌、大肠杆菌均有抑制作用,能利尿、抗过敏、镇痛、平喘、祛痰。
本发明中,所述苦参精油的来源,没有特别的限制,可提及吉安盛大香料油有限公司。
角鲨烯
角鲨烯作为烃类化合物,在有机化学中被划入萜类,是这类天然有机化合物中的一种三萜,结构符合异戊二烯规律,其系统命名为2,6,10,15,19,23-六甲基-2,6,10,14,18,22-二十四碳六烯,分子式为C30H50,相对分子质量为410.7。角鲨烯是由6个异戊二烯构成的无环三萜烯,分子中的六个双键俱为反式,是一种非环三萜结构,角鲨烯因含六个双键,极不稳定,容易氧化,在空气中放置会产生特殊臭气,易在镍、铂等金属作用下加氢形成角鲨烷。角鲨烯易环化成二环、四环、五环等三萜类化合物,通过化学反应,角鲨烯可以转变成羊毛甾醇,沟通了萜类化合物与甾体化合物之间的密切生源关系。
本发明中,所述角鲨烯的来源,没有特别的限制,可提及广州利美达进出口商贸有限公司。
本发明中,所述植物提取物和角鲨烯的重量比为(1-5):1。
在一种优选的实施方式中,所述植物提取物和角鲨烯的重量比为2:1。
本发明提供的妇科凝胶主要针对女性阴部生理健康问题,发明人采用紫苏提取物、益母草提取物、迷失香提取物和熊果苷提取物的混合物与依兰花精油和苦参精油混合制备得到的植物活性物质与角鲨烯进行复配使用,不仅具有增强阴道环境免疫系统功能、抑菌、祛除阴道异味以及活化细胞的作用,还可以改善女性患者的心理状态,具有缓解精神焦虑、平和内心的功效。发明人认为可能的原因是,角鲨烯对身体机能细胞具有显著的活化作用,并能及时将血液中的氧气输送给细胞,明显改善机体细胞的缺氧状态,活化细胞并能够避免机能细胞缺氧发生病变;同时,依兰花精油和苦参精油分别含有能够愉悦神经的安息香酸、麝子油醇等活性挥发成分以及依兰碱、甲基芒子碱等生物碱和用于消除炎症的苦参碱,两者复配对于病灶治疗实现良好的协同作用,依兰花精油在舒缓肌肤后,苦参碱更容易对皮肤深层杀菌消炎。
此外,发明人还发现,采用紫苏提取物、益母草提取物、迷失香提取物、熊果苷提取物的混合物与植物精油和角鲨烯复配使用可以进一步提高患者的体验感。发明人认为可能的原因是,一方面紫苏提取物、益母草提取物、迷失香提取物和熊果苷提取物均具有杀菌消炎的功效,能够促进凝胶作用,另一方面,熊果苷提取物中含有的熊果素在分子中引入一个葡萄糖分子,而熊果苷提取物中含有特种酚酸类化合物的两个苯环上有四个-OH,利于稳定维持角鲨烯若干个双键的化学稳定性,并降低依兰花精油对阴道壁的刺激性,维持角鲨烯对于阴道环境的注氧效果;此外紫苏提取物富含α-亚麻酸、紫苏醛、丁香酚等多种生物活性物质,可以渗透细胞并增加膜的流动性增加,促进对植物活性物质、角鲨烯的吸收,使毛细管网开放数量增多,加快血液流速、流量,使用后可改善局部的微循环障碍,增加透明质酸和弹性蛋白的吸收,恢复阴道部位的弹性。
氨基酸衍生物
氨基酸衍生物是由氨基酸通过一系列反应化合而成的物质,例如氨基酸的联合脱氨基作用合成氨基酸衍生物,也就是说氨基酸衍生物的前身是氨基酸。人体内多种物质,如肾上腺素、甲状腺激素就是氨基酸衍生物。
本发明中,所述氨基酸衍生物为辛酰氨基酸衍生物和/或月桂酰氨基酸衍生物。
在一种优选的实施方式中,所述氨基酸衍生物为辛酰氨基酸衍生物。
在一种更优选的实施方式中,所述氨基酸衍生物为辛酰甘氨酸。
在一种最优选的实施方式中,所述氨基酸衍生物为水溶性辛酰甘氨酸。
本发明中,所述水溶性辛酰甘氨酸的来源,没有特别的限制,可提及北京贝丽莱斯生物化学有限公司。
海藻酸盐
本发明中,所述妇科凝胶的制备原料还包括海藻酸盐;所述氨基酸衍生物和海藻酸盐的重量比为1:(0.05-0.5)。
在一种优选的实施方式中,所述氨基酸衍生物和海藻酸盐的重量比为1:0.2。
本发明中,所述海藻酸盐包括海藻酸钠、海藻酸钾中的至少一种。
在一种优选的实施方式中,所述海藻酸盐为海藻酸钠。
在一种更优选的实施方式中,所述海藻酸盐的细度不高于100目;所述海藻酸钠的处理方法为:将市售海藻酸钠进行研磨,过100目筛,即得。
本发明中,所述海藻酸钠的来源,没有特别的限制,可提及成都万象宏润生物科技有限公司。
发明人在实验过程中发现,向凝胶体系中添加适量辛酰甘氨酸,对金色葡萄球菌和痤疮丙酸杆菌等均有较强的抑制作用,并且可以抑制弹性蛋白酶的降解,降低阴道松弛老化速率;再复配一定量的海藻酸钠,能够增强阴道的收缩力,改善阴部的松弛状态。发明人认为可能的原因是,辛酰甘氨酸对肌肤具有良好的亲和性,且具有羧基结构;海藻酸钠是种高聚糖醛酸,具有大量的羧酸基团,海藻酸钠与辛酰甘氨酸之间具有较好的相容性,且辛酰甘氨酸对皮肤的亲和性有利于提高大分子海藻酸钠在阴道壁的附着性,从而在阴道壁上形成高分子膜,一方面牢固锁住水分,提高皮肤的滋润度,另一方面,作为阴道壁的保护膜,避免阴部环境受二次炎症破坏,给予基体一定时间修复微生态平衡,且阴道环境的温度大约是37℃-38℃,更加有利于海藻酸钠形成的高分子膜的柔软性和收缩性,改善阴部的松弛状态。
小分子醇
本发明中,所述小分子醇为C2-C4的小分子醇。
在一种优选的实施方式中,所述小分子春选自丙二醇,乙醇、甘油、丁醇中的至少一种。
在一种优选的实施方式中,所述小分子春为丙二醇、甘油、乙醇的组合。
在一种更优选的实施方式中,所述丙二醇、甘油和乙醇的重量比为1:(1-2):(0.1-0.5)。
在一种最优选的实施方式中,所述丙二醇、甘油和乙醇的重量比为1:1.5:0.2。
发明人发现,辛酰甘氨酸和海藻酸在1:(0.05-0.5)的重量比下,对于提高皮肤的滋润度和增加阴部弹性的效果会更加优异,然而对于辛酰甘氨酸的用量的依赖性较大,对于制备的妇科凝胶的耐低温和高温的稳定性产生较大的影响,尤其是对于低温环境条件下,凝胶很容易出现浑浊或是产生沉淀,一方面对贮存的条件要求苛刻,另一方面消费者购买之后由于没有严格遵守贮存和使用方法,容易造成使用和感效果大大降低。发明人意外发现,选用细度不高于100目海藻酸钠,同时在体系中加入重量比为1:(1-2):(0.1-0.5)的丙二醇、甘油、乙醇的混合物,能够显著提高妇科凝胶的贮存稳定性,适合于-10℃-40℃条件下长期存放。发明人认为可能的原因是,海藻酸钠作为一种高聚糖醛酸,具有大分子性,在温度过低条件下,协同小分子醇,能够保持高聚糖醛酸一定的柔软运动性,体系粘度降低不明显,并且丙二醇、甘油和乙醇能够稳定平衡低温对植物活性物质中析出的少量活性物的溶解,对宽温度范围的凝胶组分的溶解形成一定的缓冲。
维生素
维生素是人和动物为维持正常的生理功能而必须从食物中获得的一类微量有机物质,在人体生长、代谢、发育过程中发挥着重要的作用。维生素神经体既不参与构成人体细胞,也不为人体提供能量。
本发明中,所述维生素选自维生素A、维生素B1、维生素B2、维生素PP、维生素B4、维生素B5、维生素B6、维生素B9、维生素B12、肌醇、维生素D和维生素E中的至少一种。
在一种优选的实施例方式中,所述维生素至少包括维生素E。
本发明中,所述维生素E的来源,没有特别的限制,可提及山东爱采生物科技有限公司。
保湿剂
保湿剂是一类具有保湿和修复皮脂膜功能的化妆品原料,这类原料具有特殊分子结构,可以吸附并保留水分,在维持皮肤水合作用的同时维护皮肤屏障功能。
本发明中,所述保湿剂,没有特别的限制,可提及多元醇类、天然保湿因子、氨基酸类、生化类保湿剂等。
作为多元醇类保湿剂,可提及丙三醇、丁二醇(Butyleneglyol)、聚乙二醇、丙二醇、已二醇、木糖醇、聚丙二醇、山梨糖醇等。
作为天然保湿因子,可提及乳酸钠、尿素等。
作为氨基酸类保湿剂,可提及植物蛋白、动物蛋白、水解蛋白等。
作为生化类保湿剂,可提及胶原蛋白、糖蛋白、透明质酸、硫酸软骨素等。
增稠剂
增稠剂又称胶凝剂,是一种能增加胶乳、液体黏度的物质,用于食品时又称糊料。增稠剂可以提高物系黏度,使物系保持均匀的稳定的悬浮状态或乳浊状态,或形成凝胶;大多数增稠剂兼具乳化作用。可分为天然和合成两大类。
本发明中,所述增稠剂,没有特别的限制,可提及阿拉伯胶、果胶、琼脂、明胶、海藻胶、角叉胶、芦芭胶、糊精、可溶性淀粉、多糖衍生物、羧甲基纤维素、丙二醇藻蛋白酸酯、甲基纤维素、淀粉磷酸钠、羧甲基纤维素钠、藻蛋白酸钠、酪蛋白、聚丙烯酸钠、聚氧乙烯、聚乙烯吡咯烷酮等。
pH调节剂
酸度调节剂亦称pH调节剂,是用以维持或改变食品酸碱度的物质。发面酸了加的碱面就是酸度调节剂。它主要用以控制食品所需的酸化剂、碱剂以及具有缓冲作用的盐类。每种酸度调节剂酸味轻度和酸感特征不同。
本发明中,所述pH调节剂,没有特别的限制,可提及柠檬酸、柠檬酸钠、乳酸、磷酸氢二钠、磷酸二氢钠、磷酸二氢钾、硼酸、硼砂等。
水
本发明中,所述水,没有特别的限制,可提及去离子水、蒸馏水等。
本发明的第二个方面提供了所述的妇科凝胶的制备方法,至少包括以下步骤:将水加热至20-40℃,边搅拌边加入维生素、氨基酸衍生物和小分子醇,搅拌10-60分钟后升温至30-60℃;然后加入植物活性物质、角鲨烯、保湿剂、增稠剂、pH调节剂以及剩余原料,搅拌30-80分钟,即得。
下面通过实施例对本发明进行具体描述。有必要在此指出的是,以下实施例只用于对本发明作进一步说明,不能理解为对本发明保护范围的限制,该领域的专业技术人员根据上述本发明的内容做出的一些非本质的改进和调整,仍属于本发明的保护范围。
另外,如果没有其它说明,所用原料都是市售的。
实施例
实施例1
实施例1提供了一种妇科凝胶,所述妇科凝胶的制备原料,按重量份计,包括以下组分:植物活性物质40份、角鲨烯20份、小分子醇10份、氨基酸衍生物4份、海藻酸盐0.8份、维生素2份、保湿剂3份、增稠剂2份、pH调节剂2份、水40份。
所述植物活性物质为植物提取物和植物精油的组合,重量比为1:5;所述植物提取物为紫苏提取物、益母草提取物、迷迭香提取物和熊果苷提取物的组合,重量比为1:1.5:1:0.3;所述紫苏提取物,购买于扶风斯诺特生物科技有限公司;所述益母草提取物,购买于陕西华实生物科技有限公司;所述迷迭香提取物,购买于安徽宏通生物工程有限公司;所述熊果苷提取物,购买于西安优硕生物科技有限公司;所述植物精油为依兰精油和苦参精油的组合,重量比为1:3;所述依兰精油,购买于上海滋鑫生物科技有限公司;所述苦参精油,购买于吉安盛大香料油有限公司;所述角鲨烯,购买于广州利美达进出口商贸有限公司;所述氨基酸衍生物为水溶性辛酰甘氨酸,购买于北京贝丽莱斯生物化学有限公司;所述海藻酸盐为海藻酸钠;所述海藻酸钠,购买于成都万象宏润生物科技有限公司;所述海藻酸钠的处理方法为:将市售海藻酸钠进行研磨,过100目筛,即得;所述小分子春为丙二醇、甘油、乙醇的组合,重量比为1:1.5:0.2;所述维生素为维生素E;购买于山东爱采生物科技有限公司;所述保湿剂为透明质酸;所述增稠剂为芦芭胶;所述pH调节剂为柠檬酸;所述水为去离子水。
所述妇科凝胶的制备方法,包括以下步骤:将水加热至30℃,边搅拌边加入维生素、氨基酸衍生物和小分子醇,搅拌30分钟后升温至50℃;然后加入植物活性物质、角鲨烯、保湿剂、增稠剂、pH调节剂以及剩余原料,搅拌60分钟,即得。
实施例2
实施例2提供了一种妇科凝胶,所述妇科凝胶的制备原料,按重量份计,包括以下组分:植物活性物质20份、角鲨烯10份、小分子醇5份、氨基酸衍生物3份、海藻酸盐0.15份、维生素1份、保湿剂1份、增稠剂0.5份、pH调节剂0.5份、水30份。
所述植物活性物质为植物提取物和植物精油的组合,重量比为1:1;所述植物提取物为紫苏提取物、益母草提取物、迷迭香提取物和熊果苷提取物的组合,重量比为1:1:0.5:0.1;所述紫苏提取物,购买于扶风斯诺特生物科技有限公司;所述益母草提取物,购买于陕西华实生物科技有限公司;所述迷迭香提取物,购买于安徽宏通生物工程有限公司;所述熊果苷提取物,购买于西安优硕生物科技有限公司;所述植物精油为依兰精油和苦参精油的组合,重量比为1:1;所述依兰精油,购买于上海滋鑫生物科技有限公司;所述苦参精油,购买于吉安盛大香料油有限公司;所述角鲨烯,购买于广州利美达进出口商贸有限公司;所述氨基酸衍生物为水溶性辛酰甘氨酸,购买于北京贝丽莱斯生物化学有限公司;所述海藻酸盐为海藻酸钠;所述海藻酸钠,购买于成都万象宏润生物科技有限公司;所述海藻酸钠的处理方法为:将市售海藻酸钠进行研磨,过100目筛,即得;所述小分子春为丙二醇、甘油、乙醇的组合,重量比为1:1:0.1;所述维生素为维生素E;购买于山东爱采生物科技有限公司;所述保湿剂为透明质酸;所述增稠剂为芦芭胶;所述pH调节剂为柠檬酸;所述水为去离子水。
所述妇科凝胶的制备方法,包括以下步骤:将水加热至30℃,边搅拌边加入维生素、氨基酸衍生物和小分子醇,搅拌30分钟后升温至50℃;然后加入植物活性物质、角鲨烯、保湿剂、增稠剂、pH调节剂以及剩余原料,搅拌60分钟,即得。
实施例3
实施例3提供了一种妇科凝胶,所述妇科凝胶的制备原料,按重量份计,包括以下组分:植物活性物质50份、角鲨烯30份、小分子醇20份、氨基酸衍生物8份、海藻酸盐4份、维生素5份、保湿剂5份、增稠剂3份、pH调节剂3份、水50份。
所述植物活性物质为植物提取物和植物精油的组合,重量比为1:10;所述植物提取物为紫苏提取物、益母草提取物、迷迭香提取物和熊果苷提取物的组合,重量比为1:2:1.5:0.5;所述紫苏提取物,购买于扶风斯诺特生物科技有限公司;所述益母草提取物,购买于陕西华实生物科技有限公司;所述迷迭香提取物,购买于安徽宏通生物工程有限公司;所述熊果苷提取物,购买于西安优硕生物科技有限公司;所述植物精油为依兰精油和苦参精油的组合,重量比为1:5;所述依兰精油,购买于上海滋鑫生物科技有限公司;所述苦参精油,购买于吉安盛大香料油有限公司;所述角鲨烯,购买于广州利美达进出口商贸有限公司;所述氨基酸衍生物为水溶性辛酰甘氨酸,购买于北京贝丽莱斯生物化学有限公司;所述海藻酸盐为海藻酸钠;所述海藻酸钠,购买于成都万象宏润生物科技有限公司;所述海藻酸钠的处理方法为:将市售海藻酸钠进行研磨,过100目筛,即得;所述小分子春为丙二醇、甘油、乙醇的组合,重量比为1:2:0.5;所述维生素为维生素E;购买于山东爱采生物科技有限公司;所述保湿剂为透明质酸;所述增稠剂为芦芭胶;所述pH调节剂为柠檬酸;所述水为去离子水。
所述妇科凝胶的制备方法,包括以下步骤:将水加热至30℃,边搅拌边加入维生素、氨基酸衍生物和小分子醇,搅拌30分钟后升温至50℃;然后加入植物活性物质、角鲨烯、保湿剂、增稠剂、pH调节剂以及剩余原料,搅拌60分钟,即得。
实施例4
实施例4与实施例1的区别在于,不包括角鲨烯。
实施例5
实施例5与实施例1的区别在于,所述植物精油不包括依兰精油。
实施例6
实施例6与实施例1的区别在于,所述植物精油不包括苦参精油。
实施例7
实施例7与实施例1的区别在于,所述植物提取物不包括熊果苷提取物。
实施例8
实施例8与实施例1的区别在于,所述植物提取物不包括紫苏提取物。
实施例9
实施例9与实施例1的区别在于,不包括氨基酸衍生物。
实施例10
实施例10与实施例1的区别在于,所述氨基酸衍生物为月桂酰谷氨酸。
实施例11
实施例11与实施例1的区别在于,不包括海藻酸钠。
实施例12
实施例12与实施例1的区别在于,所述海藻酸钠被替换成羧甲基纤维素。
实施例13
实施例13与实施例1的区别在于,所述小分子醇为乙醇。
实施例14
实施例14与实施例1的区别在于,所述小分子醇被替换为聚乙二醇。
实施例15
实施例15与实施例1的区别在于,不包括小分子醇。
性能测试
1.微生物检验:将实施例1制得的妇科凝胶进行微生物检验,按《一次性使用卫生标准GB15979-2002》规定的方法进行检验,结果按照如下所示,按照如表1所示的标准判断是否符合,结果为均符合要求。
表1.实施例1制得妇科凝胶微生物检验结果
项目 | 结果 |
细菌菌落总数(cfu/g) | <4 |
大肠杆菌 | 未检测 |
绿脓杆菌 | 未检测 |
金黄色葡萄球菌 | 未检测 |
溶血性链球菌 | 未检测 |
真菌菌落总数(cfu/g) | <4 |
2.安全性测试:将实施例1制得的妇科凝胶进行安全性检验,按照国家食品药品监督管理局2003年9月1日施行的《药物非临床研究质量管理规范》的要求进行检测。具体为遵循国家食品药品监督管理局“化学药物刺激性、过敏性和溶血性研究技术指导原则”执行。
结果显示,本发明实施例1制得的妇科凝胶在7天内均对皮肤无刺激性,表明本发明提供的妇科凝胶有较高的安全性。
3.稳定性测试:将实施例制得的妇科凝胶分别置于-10±1℃和45±2℃的条件下,密封放置3个月,肉眼观察妇科凝胶的状态,测试结果如表2所示。
表2.妇科凝胶的稳定性测试结果
实施例 | -10±1℃ | 45±2℃ |
实施例1 | 无变化 | 无变化 |
实施例11 | 极少量沉淀 | 变稀、少量沉淀、少许浑浊、 |
实施例12 | 少量沉淀 | 变稀、少量沉淀、少许浑浊 |
实施例13 | 极少量沉淀 | 少量沉淀、少许浑浊 |
实施例14 | 少量沉淀 | 变稀、少量沉淀、少许浑浊 |
实施例15 | 少量沉淀 | 少量沉淀、少许浑浊 |
4.功效和使用感测试:
(1)测试样品:实施例1和4-11制得的妇科凝胶;
(2)试验对象:180名患有不同程度阴道松弛及妇科炎症的女性患者;
(3)试验方法:将受试者随机分成9组,每组20人,记为实施例1组及实施例4-11组,并分别涂抹实施例1及实施例4-11制备的妇科凝胶。所有的药物均采用专用容器注入阴道内,保留20min以上,每晚一次,7天为一疗程。使用3个疗程后,统计效果。
其中,功效判断标准:有效为症状明显好转;无效为症状无明显变化;
使用感判断标准:佳为使用过程中无任何不适;差为使用过程中出现灼烧感、粘腻感等不适。
测试结果见表3。
表3.功效和使用感测试结果
前述的实例仅是说明性的,用于解释本发明所述方法的一些特征。所附的权利要求旨在要求可以设想的尽可能广的范围,且本文所呈现的实施例仅是根据所有可能的实施例的组合的选择的实施方式的说明。因此,申请人的用意是所附的权利要求不被说明本发明的特征的示例的选择限制。在权利要求中所用的一些数值范围也包括了在其之内的子范围,这些范围中的变化也应在可能的情况下解释为被所附的权利要求覆盖。
Claims (10)
1.一种妇科凝胶,其特征在于,所述妇科凝胶的制备原料,按重量份计,至少包括以下组分:植物活性物质20-50份、角鲨烯10-30份、小分子醇5-20份、氨基酸衍生物3-8份、维生素1-5份、保湿剂1-5份、增稠剂0.5-3份、pH调节剂0.5-3份、水30-50份。
2.根据权利要求1所述的妇科凝胶,其特征在于,所述植物活性物质为植物提取物和植物精油的组合,重量比为1:(1-10)。
3.根据权利要求2所述的妇科凝胶,其特征在于,所述植物提取物包括紫苏提取物、艾叶提取物、天竺葵提取物、当归提取物、益母草提取物、玛咖提取物、迷迭香提取物和熊果苷提取物中的至少一种。
4.根据权利要求3所述的妇科凝胶,其特征在于,所述植物提取物为紫苏提取物、益母草提取物、迷迭香提取物和熊果苷提取物的组合,重量比为1:(1-2):(0.5-1.5):(0.1-0.5)。
5.根据权利要求2所述的妇科凝胶,其特征在于,所述植物精油包括玫瑰精油、依兰精油、橙花精油、豆蔻精油、苦参精油、天竺葵精油、柠檬精油、广藿香精油中的至少一种。
6.根据权利要求5所述的妇科凝胶,其特征在与,所述植物精油为依兰精油和苦参精油的组合,重量比为1:(1-5)。
7.根据权利要求1所述的妇科凝胶,其特征在于,所述植物提取物和角鲨烯的重量比为(1-5):1。
8.根据权利要求1所述的妇科凝胶,其特征在于,所述妇科凝胶的制备原料还包括海藻酸盐;所述氨基酸衍生物和海藻酸盐的重量比为1:(0.05-0.5)。
9.根据权利要求1所述的妇科凝胶,其特征在于,所述小分子醇为C2-C4的小分子醇,选自丙二醇,乙醇、丙三醇、丁醇中的至少一种。
10.一种根据权利要求1-9任一项所述的妇科凝胶的制备方法,其特征在于,至少包括以下步骤:将水加热至20-40℃,边搅拌边加入维生素、氨基酸衍生物和小分子醇,搅拌10-60分钟后升温至30-60℃;然后加入植物活性物质、角鲨烯、保湿剂、增稠剂、pH调节剂以及剩余原料,搅拌30-80分钟,即得。
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CN114712482A (zh) * | 2022-04-09 | 2022-07-08 | 朵博士健康科技(杭州)有限公司 | 一种含虾青素的洁阴抑菌凝胶及其制备方法 |
CN114762652A (zh) * | 2021-05-10 | 2022-07-19 | 山东华中生物科技有限公司 | 一种阴道凝胶及其制备方法 |
CN114762702A (zh) * | 2021-05-11 | 2022-07-19 | 山东华中生物科技有限公司 | 一种苦参凝胶及其制备方法与应用 |
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CN114762652A (zh) * | 2021-05-10 | 2022-07-19 | 山东华中生物科技有限公司 | 一种阴道凝胶及其制备方法 |
CN114762652B (zh) * | 2021-05-10 | 2024-04-09 | 山东华中生物科技有限公司 | 一种阴道凝胶及其制备方法 |
CN114762702A (zh) * | 2021-05-11 | 2022-07-19 | 山东华中生物科技有限公司 | 一种苦参凝胶及其制备方法与应用 |
CN114762702B (zh) * | 2021-05-11 | 2024-04-05 | 山东华中生物科技有限公司 | 一种苦参凝胶及其制备方法与应用 |
CN114712482A (zh) * | 2022-04-09 | 2022-07-08 | 朵博士健康科技(杭州)有限公司 | 一种含虾青素的洁阴抑菌凝胶及其制备方法 |
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