CN114404430B - 一种包含白头翁皂苷b4作为有效成分的促进生发的组合物 - Google Patents
一种包含白头翁皂苷b4作为有效成分的促进生发的组合物 Download PDFInfo
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- CN114404430B CN114404430B CN202210056920.XA CN202210056920A CN114404430B CN 114404430 B CN114404430 B CN 114404430B CN 202210056920 A CN202210056920 A CN 202210056920A CN 114404430 B CN114404430 B CN 114404430B
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
本发明公开了一种包含白头翁皂苷B4作为有效成分的促进生发的组合物。本发明通过实验发现,白头翁皂苷B4可以促进小鼠脱毛区毛发生长,提高其生长速度并增加毛囊数量,且无毒副作用,成本低,见效快。因此,可以用白头翁皂苷B4和制剂辅料制备促进生发的组合物或药物。
Description
技术领域
本发明涉及医药领域,特别涉及一种包含白头翁皂苷B4作为有效成分的促进生发的组合物。
背景技术
脱发症是指病理性脱发,即头发异常或过度脱落。多种原因可导致脱发症,如雄激素异常、精神创伤、遗传因素、内分泌异常、机体营养不良、血管机能紊乱、化学因素、机械性刺激、发育缺陷、季节性脱发等。目前FDA批准的促进生发的药物只要有米诺地尔和非那斯特莱。虽然,这些药物在一定程度上可以促进生发,但是存在不可避免的副作用。米诺地尔的长期使用会导致水肿或心律不齐,且6个月或1年后,药效减弱;非那斯特莱则会导致性功能障碍、抑郁症或产生自杀意念,甚至会增加出生缺陷的概率。此外,上述两种促进生发的药物在治疗中见效慢,费用昂贵。因此,目前亟需开发一种无毒副作用、见效快、成本低且能有效促进生发的组合物。
发明内容
针对现有技术中的缺陷,本发明提出了一种包含白头翁皂苷B4作为有效成分的促进生发的组合物。
本发明公开了一种包含白头翁皂苷B4作为有效成分的促进生发的组合物,所述组合物包括白头翁皂苷B4与制剂辅料。
白头翁皂苷B4分子式为C59H96O26分子量为1221.39,属于羽扇豆烷型的五环三萜皂苷,结构为式(Ⅰ)所示:
进一步的,所述组合物选自由洗发精、护发素、护发精油、护发精华、护发喷雾、生发水、发胶、发露、发膜、定发剂、摩丝、焗油膏及染发剂组成的组中的任一形态。
本发明还提供一种促进生发的药物,包含所述的促进生发的组合物。
进一步的,所述药物为乳液、霜剂、丸剂、滴丸剂、胶囊剂、颗粒剂、散剂、涂剂、巴布剂、喷雾剂、口服液、汤剂、注射剂、缓释制剂或控释制剂中的任意一种。
进一步的,所述白头翁皂苷B4的有效浓度为0.5~2mg/mL。
本发明还提供白头翁皂苷B4在制备促进生发组合物中的应用。
进一步的,所述组合物选自由洗发精、护发素、护发精油、护发精华、护发喷雾、生发水、发胶、发露、发膜、定发剂、摩丝、焗油膏及染发剂组成的组中的任一形态。
本发明还提供白头翁皂苷B4在制备促进生发药物中的应用,所述药物为乳液、霜剂、丸剂、滴丸剂、胶囊剂、颗粒剂、散剂、涂剂、巴布剂、喷雾剂、口服液、汤剂、注射剂、缓释制剂或控释制剂中的任意一种。
本发明还提供白头翁皂苷B4作为唯一活性成分在制备所述组合物中的应用。
本发明还提供白头翁皂苷B4作为唯一活性成分在制备所述药物中的应用。
综上,与现有技术相比,本发明达到了以下技术效果:
1.本发明针对目前临床上促进生发亟待解决的药物需求,发现了白头翁皂苷B4可有效促进生发的新用途。
2.白头翁皂苷B4作为组合物或药物的有效成分,安全性良好、无毒副作用。
3.白头翁皂苷B4相对于现有的西药,价格低廉,降低治疗成本,减轻患者经济负担,符合目前临床的需求。
4.本发明的包含白头翁皂苷B4作为有效成分的促进生发的组合物连续使用2周即可见效,见效快,治疗周期短。
附图说明
为了更清楚地说明本发明实施例的技术方案,下面将对实施例中所需要使用的附图作简单地介绍,应当理解,以下附图仅示出了本发明的某些实施例,因此不应被看作是对范围的限定,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他相关的附图。
图1为本发明实施例各组小鼠背部去毛区的皮肤图片。
图2为本发明实施例各组小鼠去毛区皮肤HE染色结果。
图3为本发明实施例各组小鼠毛囊数量的统计结果。
图4为本发明实施例各组小鼠毛发生长速度评分。
图5为本发明实施例各组小鼠体重的统计结果。
具体实施方式
为了使本技术领域的人员更好地理解本发明方案,下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分的实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例,都应当属于本发明保护的范围。
除非特别说明,本发明采用的试剂、方法和设备为本技术领域常规试剂、方法和设备。
实施例1
(1)实验动物
购自中国食品药品检定研究院,KM小鼠,雄性,18-20g,spf级,生产许可证号:SCXK2017(京)-0005。在中国中医科学院中医基础理论研究所实验动物中心,屏障环境内饲养,许可证号SYXK(京)2021-0017。
(2)实验试剂
脱毛剂:薇婷脱毛膏,利洁时(法国)有限公司生产。进口化妆品批准文号:国妆特进字J20130034;阳性药米诺地尔搽剂:山西振东安特生物制药有限公司。
(3)造模及给药方法
除正常对照组外,其余组别小鼠背部全部脱毛。
动物分组:空白组、模型组、基质凡士林组、白头翁皂苷B4-低剂量组、白头翁皂苷B4-中剂量组、白头翁皂苷B4-高剂量组、阳性药米诺地尔搽剂,每组10只小鼠。各组的白头翁皂苷B4和米诺地尔搽剂使用凡士林溶解,凡士林组给予基质组凡士林,白头翁皂苷B4低、中、高剂量分别为0.5、1、2mg/mL,每天给药2次,连续给药2周后,取材,取各组小鼠去毛区皮肤,固定,并进行HE染色,显微镜下统计毛囊数目。
(4)观测指标
(A)背部毛发生长情况
拍照片比较各组别小鼠背部脱毛区皮肤生长的程度,以评价生发的速度(评分标准按照参考文献[夏天,黎文乾,夏星,何伟平,朱晓韵.银杏生发合剂促进小鼠毛发生长的作用研究.广西中医药,2013,36(05):69-72]为:无毛生长-0分,浅毛长满脱毛区-1分,新生毛长度与密度约为未脱毛区的一半-2分,新生长与未脱毛区无差别-3分);
(B)皮肤内毛囊数
小鼠处死后,将背部皮肤组织固定后,石蜡切片HE染色统计皮肤内的毛囊数,以评价促进生发的功效。
连续给药2周后,拍摄各组小鼠背部去毛区的皮肤图片,由图1可知,模型组毛发生长较少,溶解基质凡士林对毛发生长无显著影响,说明基质不存在促生发功效,白头翁皂苷B4低、中、高剂量以及阳性药米诺地尔酊均可不同程度促进小鼠背部去毛区的毛发生长。对各组小鼠的皮肤取材,进行包埋切片,而后进行HE染色,HE染色结果见图2,结果可见,白头翁皂苷B4低、中、高剂量组的毛囊数量相较于模型组明显增多;根据HE染色图片统计各组小鼠皮肤组织中的毛囊数量,结果见图3,与空白组相比,模型组小鼠背部去毛区皮肤中的毛囊数量显著减少;基质凡士林对毛发生长无明显影响;白头翁皂苷B4低、中、高剂量组可显著增加小鼠背部去毛区皮肤的毛囊数量。图2和图3的结果证明白头翁皂苷B4确实有增加毛囊数量的作用。各组小鼠毛发生长速度评分见图4,由图4可知,基质凡士林组与模型组的毛发生长速度评分不存在显著差异,说明溶解基质无促进生发的功效;与模型组相比,白头翁皂苷B4高剂量组显著加速了小鼠背部去毛区的毛发生长速度。此外,图5的结果表明,给药2周时间对小鼠的体重无明显影响,说明白头翁皂苷B4对小鼠无毒副作用。
综上所述,可确定通过使用白头翁皂苷B4可以达到以下技术效果:
(1)促进小鼠脱毛区毛发生长.
(2)提高毛发生长速度。
(3)增加毛囊数量。
(4)无毒副作用。
(5)连续给药2周即可见效,见效快,治疗周期短。
本发明可根据成分种类、成分含量、剂型等产生多个实施方式。例如:
实施方式1:以白头翁皂苷B4为有效成分的洗护产品;
可制备成选自由发精、护发素、护发精油、护发精华、护发喷雾、生发水、发胶、发露、发膜、定发剂、摩丝、焗油膏及染发剂组成的组中的任一形态。
实施方式2:以白头翁皂苷B4为有效成分的乳液或霜剂;
通常将常温下呈半固态的称为霜剂,称流体状态的称为奶液或乳液,乳液是互不相溶的两种液体,其中一相以微小液滴分散于另一相中所形成的体系,通常把以液珠形式存在的一相称为分散相或内相另外一相称为分散介质或外相。
乳液或霜剂常用的辅料有:乳化剂、抗氧剂、增粘剂、pH调节剂、油质原料。
乳化剂:为形成稳定的乳状液,乳化剂的加入是必需的。
pH调节剂:为避免过强的刺激性和提高稳定性,常用缓冲溶液来稳定药液的pH值。常用的缓冲溶液有硼酸缓冲液、磷酸盐缓冲液等。
增粘剂:常用甲基纤维素(MC)、聚乙烯醇(PVA)、卡波沫和聚维酮(PVP)等,CMC-Na不常用,因其与生物碱盐及洗必泰有配伍禁忌。
油质原料:乳液或霜剂中经常添加各类油质原料,对其成形、稳定或赋予色、香以及其它特性起作用,这些物质配方中用量不大,但却极其重要。主要包括油脂,如蜡类、烃类和合成油脂。
实施方式3:以白头翁皂苷B4为有效成分的口服液;
以口服液为例,口服液是在汤剂、注射剂基础上发展起来的新剂型,具有剂量小、吸收较快、质量稳定、携带和服用方便、易于保存的优点,其含有多种有效成分,对质量和口感有很大的影响。在不改变主要活性成分结构和功能前提下,如何能最大限度的保留有效成分、改善口感是其选用辅料的一个难点。在口服液中添加辅料可以提高口感,改善澄清度,增强稳定性,提高产品质量。
口服液常用辅料有:溶剂、芳香剂、矫味剂、澄清剂、防腐剂等,这些辅料可同时加入,也可择其一加入,其中溶剂是必加的,可以采用水。不同的辅料组合有甜味剂、芳香剂、澄清剂或防腐剂,或甜味剂和防腐剂的组合,优选甜味剂和防腐剂的组合。部分辅料兼具增甜和增香的作用,此时只需加入一种辅料即可。
针对口服液,优选地,所述甜味剂选自蛋白糖、木糖醇、阿斯巴甜和三氯蔗糖中的一种或多种。
针对口服液,优选地,所述防腐剂选自对羟基苯甲酸酯、丁基羟基茴香醚、丁基羟基甲苯和山梨酸中的一种或多种。
防腐剂可选用对羟基苯甲酸酯、丁基羟基甲苯或山梨酸,优选丁基羟基甲苯。也可以组合使用,例如羟基苯甲酸酯与丁基羟基甲苯的组合,或丁基羟基甲苯与山梨酸的组合,或对羟基苯甲酸酯与山梨酸的组合,或对羟基苯甲酸酯、丁基羟基甲苯和山梨酸的组合。
针对口服液,优选地,所述芳香剂为水果香精。
针对口服液,优选地,所述澄清剂为壳聚糖和明胶中的一种或两种混合。
实施方式4:以白头翁皂苷B4为有效成分的片剂;
片剂具有剂量准确,质量稳定,服用、携带及运输方便等优点。
针对片剂,所述制剂辅料包括稀释剂、粘合剂、润滑剂和崩解剂中一种或多种,优选稀释剂、粘合剂、润滑剂和崩解剂的组合。
针对片剂,优选地,所述稀释剂为纤维素类和无机盐类中的一种或多种。例如微晶纤维素、硫酸钙、磷酸氢钙及药用碳酸钙、甘露醇等,以增加原料体积助其成型的。
针对片剂,优选地,所述粘合剂为水、乙醇、羧甲基纤维素钠、羟丙基纤维素、甲基纤维素、乙基纤维素、明胶和聚乙烯吡咯烷酮等中的一种或多种。
针对片剂,优选地,所述润滑剂为硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇和月桂醇硫酸镁中的一种或多种。
针对片剂,优选地,所述崩解剂为低取代羟丙基、交联聚乙烯吡咯烷酮和交联羧甲基纤维素钠等中的一种或多种。
实施方式5:以白头翁皂苷B4为有效成分的胶囊;
在本发明中,胶囊主要提高稳定性和生物利用度。所述制剂辅料为胶囊壳,所述胶囊壳为硬胶囊壳或软胶囊壳。
实施方式6:以白头翁皂苷B4为有效成分的颗粒剂;
颗粒剂可以直接吞服,也可以用温水冲入水中饮入,应用和携带比较方便,溶出和吸收速度较快。颗粒剂所用的制剂辅料与片剂相似,涉及填充剂、粘合剂、润湿剂、崩解剂、润滑剂和薄膜包衣材料中的一种或多种。
针对颗粒剂,优选地,所述填充剂为纤维素类和无机盐类中的一种或多种。例如微晶纤维素、硫酸钙、磷酸氢钙及药用碳酸钙、甘露醇等,以增加原料体积助其成型的。
针对颗粒剂,优选地,所述粘合剂为水、乙醇、羧甲基纤维素钠、羟丙基纤维素、甲基纤维素、乙基纤维素、明胶和聚乙烯吡咯烷酮等中的一种或多种。
针对颗粒剂,优选地,所述润湿剂为水或乙醇或两者的混合。例如为硬脂酸镁、微粉硅胶、滑石粉、氢化植物油、聚乙二醇和月桂醇硫酸镁中的一种或多种。
针对颗粒剂,优选地,所述崩解剂为低取代羟丙基、交联聚乙烯吡咯烷酮和交联羧甲基纤维素钠等中的一种或多种。
针对颗粒剂,优选地,所述薄膜包衣材料羟丙基甲基纤维素、聚乙二醇、醋酸纤维素酞酸酯和聚乙烯缩乙醛二乙胺醋酸酯中的一种或多种。
实施方式7:以白头翁皂苷B4为有效成分的散剂。
本发明也可制成散剂,散剂便于分剂量和服用。
以饮料为例,将本发明的组合物制成不同风味的饮料,作为日常饮品将深受欢迎。
饮料所用的制剂辅料为澄清剂、防腐剂和香味剂中的至少一种。
本发明的组合物也可制成其它散剂,例如制成功能性奶粉,加入的辅料主要为奶粉,例如脱脂奶粉,脱脂无糖奶粉。
以上多个实施方式可调整单位产品中的剂量大小,以适应不同的用途,如药品、保健品、食品等。
综合以上实施例,本发明公开了一种包含白头翁皂苷B4作为有效成分的促进生发的组合物。所述组合物包括白头翁皂苷B4与制剂辅料。本发明通过实验发现,白头翁皂苷B4可以促进小鼠脱毛区毛发生长,提高其生长速度并增加毛囊数量,且无毒副作用,成本低,见效快。因此,可以用白头翁皂苷B4和制剂辅料制备促进生发的组合物或药物。
以上所述仅为本发明的较佳实施例,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、改进等,均应包含在本发明的保护范围之内。
Claims (1)
1.白头翁皂苷B4作为唯一活性成分在制备促进生发组合物中的应用。
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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