CN112773879A - 一种中药生发育发组合物及其制剂 - Google Patents
一种中药生发育发组合物及其制剂 Download PDFInfo
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Abstract
本发明公开了一种生发的中草药组合物及制剂。该组合物主要含有以下成分:地榆、侧柏叶、干姜、枇杷叶、银杏叶、蒲公英、甘草。该组合物经一定的提取工艺得到相应的提取物,具有较好的抗菌和抗炎作用。以本组合物为基础,以卡波姆为基质,以60%醇为溶剂,加入甘油,丙二醇,氮酮等制备成外用水凝胶,外用在头皮处,具有抗炎、抗菌、活血、营养毛囊等作用,通过增加毛囊的数量与活性,使头发增多增密,达到生发育发的功效。
Description
技术领域
本发明属于美容美发领域,具体涉及一种生发育发的中药组合物及其制剂。
背景技术
现今社会发型与头发长短对人的生活至关重要,但随着社会的发展,生活压力的增大,脱发患者日益增多,且趋于年轻化,对患者的生活质量造成及大影响。据文献报道,脱发的发病率高达30.2%,且呈上升趋势,其病理复杂,病程长久,仍是医学界的难题。
毛发生于毛囊,毛囊的生长具有周期性,可分为生长期,退行期、休止期,正常的脱发主要是由于毛囊处于退行期及休止期,但各时期的毛囊处于动态平衡中,对于脱发患者,其毛囊萎缩,无法进入生长期,从而导致毛发逐渐稀疏。
目前治疗脱发的中西医药物不少,西药经FDA批准的有米诺地尔、非那雄胺,但其都有不足之处,米诺地尔停药易复发,非那雄胺长期使用会造成生殖***的损伤;中药治疗脱发的药物较多,但效果往往不理想,且价格昂贵,疗程极长,因此对于寻找一种材料易得,使用方便,疗效显著不反弹的生发剂,很有价值。
中医治疗脱发古已有之,而常用的脱发中草药较多,经实验研究一些中药具有较好的生发功效,介绍如下:
地榆,始载于《神农本草经》,属蔷薇科,其性微寒,苦、涩、酸,具有凉血、止血的功效。现代医学研究证明,地榆富含黄酮与没食子酸,具有较好的抗菌与抗炎作用。
干姜,属姜科植物,在中国具有悠久的用药历史,中医理论认为其味辛热,归脾胃肾心肺经,可温中散寒。现代医学研究证明,干姜可起到升高血压,抗凝血等作用,干姜中姜辣素可活化透皮毛细血管,促进透皮微循环,促进毛囊营养。
侧柏叶,属柏科植物侧柏的干燥枝叶,中医理论认为其性味苦涩,性寒,具有凉血止血的功效。现代医学研究证明,侧柏叶中的黄酮抗菌抗炎效果显著;
枇杷叶,枇杷叶属蔷薇科琵琶属植物,琵琶的干燥叶,是一种常用中药。中医理论认为枇杷叶具有清肺止咳,止呕的作用,对各种肺热咳嗽效果显著。现代研究证明,枇杷叶重富含三萜酸,黄酮类,倍半萜及苷类,日本研究学者还发现其中的三萜酸具有抗癌活性。
银杏叶,银杏叶为银杏科植物银杏的干燥叶子,中医理论中,银杏叶可用于治疗咳嗽,各种心脏疾病,高血压,高血脂等。银杏叶提取物主要化学成分为黄酮类,现代研究证明酯类等,银杏叶中黄酮与萜类物质可清除自由基,抗细胞衰老,促进血管微循环。
蒲公英,属菊科植物,味苦,甘,性寒。具清热解毒,去肿化瘀的功效,现代医学研究证明,蒲公英富含铁、钙等多种矿物质,可较好地促进毛囊营养;
甘草,又名国草,甜草,属豆科,多年生草本,具有较强的补益性,可清热解毒、祛痰止咳等,是中医广泛使用的一种药材。其中的甘草酸具抗炎抗过敏的作用。
中国专利CN201810728202.6公开了一种生发护发中药组合物及制剂,其中中药材为地榆,蒲公英,银杏叶,獐牙菜。采用95%醇提方法制备中药提取物,具有治疗脂溢性脱发的作用,不足之处在于生发功效不够理想。
中国专利CN201710076200.9公布了一种治疗脱发中药组合物及其制备方法,其中药材主要为当归,帝皇,川芎,桑葚,黄芪,黑芝麻,桑葚,制首乌,女贞子,侧柏叶,各药产生协同作用,产生促进生发的效果,其不足之处在于药材配比繁琐,且制备工艺复杂,耗时较长。
发明内容
本发明针对现有技术的不足,进一步优化前述以獐牙菜,银杏叶,蒲公英为主要成分的中草药生发复方,通过大量试验进行筛选,得到一种原料易得,效果更加显著、使用更加方便的中草药复方生发育发物。
为实现上述目的,本发明提供如下技术方案:
一种生发育发的中药组合物,以重量计,包含:地榆10—30份,干姜10—30份,侧柏叶10—30份,枇杷叶10—20份,银杏叶0—20份,蒲公英0—20份,甘草10-20份。
优选的,所述中药组合物,以重量计,包含:地榆10—30份,干姜10—30份,侧柏叶10—30份,枇杷叶10—20份,银杏叶10—20份,蒲公英10—20份,甘草10-20份。
更优选的,所述中药组合物,以重量计,包含:地榆20—30份,干姜20份,侧柏叶20份,枇杷叶10—20份,银杏叶10份,蒲公英10份,甘草10份。
本发明所述的生发育发的中药组合物,可以通过如下方法制备:将中药材粉碎后,按照上述的中药材质量份数,称取中药材粉末,加入5-20倍量的60-95%乙醇浸泡过夜,75℃加热提取两次,合并提取液,过滤,常规浓缩至浓稠状膏体,得到所述的中药组合物。
本发明还提供一种生发育发的中药水凝胶,所述水凝胶的制备方法如下:
①以2%-3%的卡波姆940作为基质,取4份该基质,加入1.5份的甘油得A;
②称取中药组合物约2份,加入一定浓度60%的乙醇溶液1.5份,搅拌使其充分混合均匀得B;
③搅拌下将B缓缓加入到A中,混合均匀得C;
④在C中加入氮酮0.2份、香精0.5份,充分搅拌混合均匀得D;
⑤边搅拌边缓慢滴加三乙醇胺到D中,使其粘度达到3.5±0.5Pa·s,封装,即得所述的中药水凝胶。
本发明所述的生发育发中药组合物或中药水凝胶可以用来制备生发育发的普通化妆品、药用化妆品或中药外用制剂。
本发明所述的各种中药材,包括相应的原药材或其饮片。
本发明从改善头皮环境及激活毛囊的角度,结合中草药中的黄酮、多糖、有机酸等活性成分,对中草药复方进行初筛,同时建立小鼠脱发模型,研究组合复方的生发功效,发现地榆、侧柏叶、干姜、枇杷叶、银杏叶、蒲公英、甘草组合物具有较好的促生发功效,具有较好的创新性、实用性。
本发明提供的中药组合物,经动物实验证明其毒副作用小,可长期使用。
本发明的积极效果是:该制剂使用方便,原料药材常见易得,制备工艺简单,最重要的是用于筛选的动物模型经过科学合理的设计,脱发模型需要先经过一个月的诱导,更加接近于人类的脱发症状,然后再使用模型进行生发组方的筛选。且充足的动物实验证明,其中药材组合科学合理,其促生发效果与前述公布专利相比得到提升,相较于化学剂米诺地尔安全无毒副作用,可以长期使用。
具体实施方式:
下面结合动物实验对本发明作进一步的说明,下述实施例仅仅是本发明的典型实施例,本发明保护范围并不局限于所述内容。
表1实施例1-2的处方
组别 | 地榆 | 干姜 | 侧柏叶 | 枇杷叶 | 银杏叶 | 蒲公英 | 甘草 | 獐牙菜 |
1<sup>*</sup> | 20 | 0 | 0 | 0 | 20 | 20 | 0 | 20 |
2 | 20 | 20 | 0 | 0 | 20 | 20 | 20 | 0 |
3 | 20 | 20 | 20 | 20 | 10 | 10 | 10 | 0 |
4 | 30 | 20 | 20 | 10 | 10 | 10 | 10 | 0 |
5 | 10 | 30 | 10 | 10 | 20 | 20 | 10 | 0 |
6 | 20 | 10 | 30 | 10 | 10 | 20 | 10 | 0 |
*实验第1组为对前述中国专利CN201810728202.6的考察
实施例1:
中药提取物的制备:按表1中1,2,6组分别称取各比例药材,加入10倍量95%乙醇,浸泡12h,75℃回流提取2h,提取两次,合并提取液,过滤,55℃减压浓缩至膏状物,即分别得到组合提取物1,2,6。
实施例2:
中药提取:按表中3,4,5组分别称取各比例药材,加入10倍量60%乙醇,浸泡12h,75℃回流提取2h,提取两次,合并提取液,过滤,55℃减压浓缩至膏状物,即分别得到组合提取物3,4,5。
实施例3
外用水凝胶的制备:
①以2%-3%的卡波姆940作为基质,取4份该基质,加入1.5份的甘油得A;
②称取实施例1或2制备的中药组合物提取物2份,加入60%乙醇溶液1.5份,搅拌使其充分混合均匀得B;
③搅拌下将B缓缓加入到A中,混合均匀得C;
④在C中加入氮酮0.2份、香精0.5份,充分搅拌混合均匀得D;
⑤边搅拌边缓慢滴加三乙醇胺到D中,使其粘度达到3.5±0.5Pa·s,封装,即得外用生发育发水凝胶。
空白水凝胶的制备:同上述制备方法,在第②步中药组合物用空白基质代替。
实施例4生发效果考察实施例
实验动物:C57小鼠60只,雄性,体重18-20g,SPF级,由上海西普尔-必凯动物实验有限公司提供,动物生产许可证号:SCXK(沪)2013-0016
实验方法:
小鼠脱发模型造模:
1)小鼠的脱毛小鼠腹腔注射4%水合氯醛(0.1ml/10g)麻醉后,待其处于麻醉状态下用剃刀剃除1.5*1.0cm2项部毛发,使其只剩极短皮肤短毛。每只小鼠项部脱毛区均匀涂抹6%硫化钠0.6ml,在硫化钠停留于小鼠项部150s后迅速洗去项部毛发,使小鼠项部皮肤裸露出来。
2)咪喹莫特诱导脱发模型选取项部皮肤为浅红色的小鼠,对其脱毛区涂抹咪喹莫特软膏,0.1g/只,每日一次,每周一、三、五、日涂抹,给咪喹莫特前用生理盐水清洁项部皮肤,以去除前次残留咪喹莫特,四周后,小鼠项部皮肤出现较明显角质***且无毛的区域,造模成功,停止涂抹咪喹莫特。
分组与给药:将造模成功的小鼠分为8组,每组6只,即空白对照组、阳性组及观察组(6组);其中空白对照组:涂抹空白凝胶,阳性组涂抹市售化学生发药米诺地尔酊剂0.2ml/只,其余6组分别用中药组合物1-6制备的水凝胶;用量均为0.2g/次,每日2次,上午10时与下午4时给药(定时给药以保证实验的稳定性)。
实验终点确定:以阳性组小鼠完全恢复毛发至未脱毛区正常长度为实验终点(约为30天)。
注意事项:A:脱毛后观察皮肤颜色,只有红色皮肤小鼠毛发处于静止期,因此选取红色皮肤的小鼠。B:给药动作轻柔,持续2-3min,使药物充分被吸收,给药后约15min再放回鼠笼以防垫料擦干药物。
检测指标:A.小鼠毛发生长情况评分:每4日观察各组小鼠皮肤及被毛生长情况,对不同组起始项部颜色相同的小鼠进行比较,并对小鼠皮肤毛发生长情况进行评分,评分标准如下:
*不规则毛生长按面积比率计算,如50%红色,50%灰色,则记录0.5分。
B.新生毛长记录:在实验终点时于脱毛处理区拔取最长一撮毛,选取最长3根,使用游标卡尺测量其长度,记录,计算均值;
C.新生毛重记录:实验终点在脱毛区域用剪刀沿毛发根部剪下相同面积的新生毛发,分析天平称重,记录。
实验结果:
小鼠毛长毛重的比较:
表2各组毛长毛重比较(n=6,x±SD)
备注:在毛粗细相同的情况下,毛重/毛长的值与单位面积毛发根数(毛发的密度)呈正相关;
因脱发患者更加需要增加单位面积的毛发根数而非长度,因此增加毛重/毛长的值比单纯增加毛长更具有现实意义。
结果可见,比较各组小鼠毛发和毛重/毛长的值,空白对照组小鼠毛长与毛重/毛长的值均低于阳性药米诺地尔组,说明造模成功。本发明的中药组合物2-6组均不同程度高于空白对照组,证明其有生发功效。组合物2-6组的毛发的密度高于组合物1组(即专利CN201810728202.6组),说明本发明的组合物与现有中药组合物相比,取得了更好的生发效果。而加入银杏叶与蒲公英后小鼠的生发密度进一步增加,具有更显著的生发育发效果。
Claims (6)
1.一种生发育发的中药组合物,其特征在于,以重量计,包含:地榆10—30份,干姜10—30份,侧柏叶10—30份,枇杷叶10—20份,银杏叶0—20份,蒲公英0—20份,甘草10-20份。
2.如权利要求1所述的中药组合物,其特征在于,以重量计,包含:地榆10—30份,干姜10—30份,侧柏叶10—30份,枇杷叶10—20份,银杏叶10—20份,蒲公英10—20份,甘草10-20份。
3.如权利要求1所述的中药组合物,其特征在于,以重量计,包含:地榆20—30份,干姜20份,侧柏叶20份,枇杷叶10—20份,银杏叶10份,蒲公英10份,甘草10份。
4.如权利要求1-3任一所述的中药组合物,其特征在于,所述中药组合物通过如下方法制备:将中药材粉碎,按照中药材重量份数,称取中药材粉末,加入5-20倍量的60-95%乙醇浸泡过夜,75℃加热提取两次,合并提取液,过滤,常规浓缩至浓稠状膏体,得到所述的中药组合物。
5.一种生发育发的中药水凝胶,其特征在于,所述水凝胶通过如下方法制备:
①以2%-3%的卡波姆940作为基质,取4份该基质,加入1.5份的甘油得A;
②称取权利要求4所述的中药组合物约2份,加入60%乙醇溶液1.5份,搅拌使其充分混合均匀得B;
③搅拌下将B缓缓加入到A中,混合均匀得C;
④在C中加入氮酮0.2份、香精0.5份,充分搅拌混合均匀得D;
⑤边搅拌边缓慢滴加三乙醇胺到D中,使其粘度达到3.5±0.5Pa·s,封装,即得所述的中药水凝胶。
6.如权利要求1-5所述的任一中药组合物或中药水凝胶,在制备生发育发的普通化妆品、药用化妆品或中药外用制剂方面的应用。
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