CN110680877A - 一种用于修复阴道损伤的中药组合物及其制备方法 - Google Patents
一种用于修复阴道损伤的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明提供了一种用于修复阴道损伤的中药组合物及其制备方法,精选以下合理配伍的中药组合而成:白芨30‑70份、大云10‑50份、仙灵脾10‑30份、当归5‑15份紫草5‑15份、蛇床子5‑15份、苦参5‑15份、肉桂2‑8份、泽兰10‑15份、血竭1‑5份、硫磺0.5‑2.5份、壳聚糖0.5‑2.5份、岗松油0.005~0.02份。再加入10~35份的卡波姆,制成外用凝胶剂。本发明无副作用,采用以上中药成分,能够有效修复阴道损伤,修复阴道的免疫力,对其他妇科疾病具有辅助治疗,且制备方法稳定可行,适用于大量生产。本发明产品的效果优于同行业产品20倍以上,具有消炎抑菌、杀虫止痒、修复受损组织以及提高女性性敏感度等良好效果。
Description
技术领域
本发明属于女性生殖修复药物领域领域,具体涉及一种用于修复阴道损伤的中药组合物及其制备方 法。
背景技术
现有的妇科阴道修复药物种类繁多,凝胶作为阴道修复药物的一种因为其使用方便而得到广泛应用, 但现有的阴道修复型凝胶大多疗程较长且易反复,或有较大的副作用。
另外,中国专利CN1114566中所公开的阴道外用药,具有消炎、除湿、止痒等作用,但对外阴、阴道 粘膜等部位的损伤,如炎症及激光等物理疗法后所造成的局部损伤和溃疡的主动修复却无能为力。
发明内容
本发明的目的在于提供一种用于修复阴道损伤的中药组合物。
本发明的另一种目的在于提供一种上述中药组合物的制备方法。
为了上述目的,本发明技术方案如下:
一种用于修复阴道损伤的中药组合物,精选以下合理配伍的中药组合而成:
优选的是,上述用于修复阴道损伤的中药组合物,由以下重量份的中药原料组成:
优选的是,上述用于修复阴道损伤的中药组合物,由以下重量份的中药原料组成:
上述中药组合物的剂型为凝胶剂、或软膏剂;最适宜剂型为凝胶剂;软膏剂次之。
上述凝胶剂中需再加入10~35份的卡波姆。
一种用于修复阴道损伤的中药组合物的制备方法,通过以下步骤:
(1)按比例称取1.5g壳聚糖、25g卡波姆和1.5g硫磺加180ml水混合,再加入0.01g的岗松油,混 合均匀,使其自然溶胀,得凝胶基质溶液,备用;
(2)将白芨、大云、仙灵脾、当归、紫草、蛇床子、苦参、肉桂、泽兰和血竭通过超生破壁层析吸 附技术提取其有效成分提取物;按比例称取中药提取物白芨50g、大云30g、仙灵脾20g、当归10g、紫草10g、蛇床子10g、苦参10g、肉桂5g、泽兰10g和血竭3g混合均匀,得到中药混合细粉;
(3)将上述中药混合细粉加入至凝胶基质溶液,搅匀,加足量配有氢氧化钠的纯化水,便加边搅拌, 调整其pH值为5-7,搅匀即得凝胶产品;
(4)罐装成品:小管灌装,每支3克。
进一步的,上述超生破壁层析吸附技术:将干燥的中药材连续三次超声破壁,获得药材超细粉;加入 乙醇溶液,密封浸泡2小时,超声波辅助下处理20分钟;然后搅拌浸提后离心,得到有效成分粗提物; 将有效成分粗提物pH值调至12左右,搅拌浸提3小时,离心去沉淀,上清液pH调至4.04.5;将得到的 上清液经过大孔树脂层析吸附;用20%乙醇溶液洗脱,得到含亚有效成分的醇溶液,用旋转蒸发仪进行浓 缩,冷冻干燥,得到有效成分提取物。
上述中药组合物剂型为软膏剂的制备方法:
(1)同样将白芨、大云、仙灵脾、当归、紫草、蛇床子、苦参、肉桂、泽兰通过超生破壁层析吸附 技术提取其有效成分提取物;按比例称取中药提取物白芨60g、大云40g、仙灵脾25g、当归12g、紫草12g、 蛇床子12g、苦参12g、肉桂7g、泽兰12g和血竭3g混合均匀,得到中药混合细粉;
(2)在上述中药混合细粉中加入500ml的纯化水,并加入2g硫磺、2g壳聚糖、0.015g岗松油,搅匀;
(3)收膏,加入真空乳化罐进行乳化45分钟;
(5)成品:乳化以后静置两小时即可罐装,罐装的裸支就是半成品;半成品再经过包装就是成品。
上述原料的功能与作用:
(1)白芨:苦、甘、涩,微寒。归肺、肝、胃经。具有收敛止血,消肿生肌之功效。用于咳血吐血, 外伤出血,疮疡肿毒,皮肤皲裂;肺结核咳血,溃疡病出血。
(2)大云:又名肉苁蓉。甘、咸,温。肾经、大肠经。具有补肾阳,益精血,润肠通便之功效。用 于阳痿,不孕,腰膝酸软,筋骨无力,肠燥便秘。
(3)仙灵脾:又称淫羊藿。辛、甘,温。归肝、肾经。具有补肾阳,强筋骨,祛风湿之功效。用于 阳痿遗精,筋骨痿软,风湿痹痛,麻木拘挛;更年期高血压。
(4)当归:昧甘、辛,性温。归肝、心、脾经。具有补血活血,调经止痛,润肠通便之功效。用于 血虚萎黄、眩晕心悸、月经不调、经闭痛经、虚寒腹痛、肠燥便秘、风湿痹痛、跌扑损伤、痈疽疮疡。
(5)紫草:味甘、咸,性寒。归心、肝经。具有凉血,活血,解毒透疹之功效。用于血热毒盛、斑 疹紫黑、麻疹不透、疮疡、湿疹、水火烫伤。清热凉血,用于麻疹,热病癍疹,湿疹,尿血,血淋,血痢, 疮疡,丹毒,烧伤,热结便秘。
(6)蛇床子:辛、苦,温;有小毒。归肾经。具有温肾壮阳,燥湿,祛风,杀虫之功效。用于阳痿, 宫冷,寒湿带下,湿痹腰痛;外治外阴湿疹,妇人阴痒;滴虫性阴道炎。
(7)苦参:味苦,性寒。归肝、肾、大肠、小肠经;心经,膀胱经。具有清热燥湿;祛风杀虫之功 效。主湿热泻痢;肠风便血;黄疸;小便不利;水肿;带下;阴痒;疥癣;麻风;皮肤瘙痒;湿毒疮疡
(8)肉桂:味辛、甘,性大热。具有补火助阳,引火归源,散寒止痛,活血通经之功效。用于阳痿、 宫冷、心腹冷痛、虚寒吐泻、经闭、痛经、温经通脉。
(9)泽兰:味苦、辛,性微温。具有活血化瘀,行水消肿之功效。用于月经不调、经闭、痛经、产 后瘀血腹痛、水肿。
(10)血竭:甘、咸,平。心经、肝经。具有活血散瘀,定痛,止血生肌,敛疮之功效。主治跌打肿 痛,内伤瘀痛;外伤出血不止,瘰疬,臁疮溃久不合。
(11)硫磺:酸,温;有毒。脾经、肾经。壮阳,杀虫。治阳痿,虚寒泻痢,大便冷秘;外用治疥癣, 湿疹,癞疮,止痒杀虫疗疮;内服补火助阳通便。
(12)壳聚糖:可作为食品添加剂使用,因其生物相容性良好,在生物医学及制药等方面的应用极其 广泛,可用作烧伤敷料及伤口愈合剂,包扎纱布用壳聚糖处理后,伤口愈合速度可提高75%。
(13)岗松油:作为高级杀菌药用油,广泛用于各种妇科病、性病、皮肤病外用洗液和药膏等原料。 具有化瘀止痛、清热解毒、利尿通淋、杀虫止痒之功效。用于跌打瘀肿、肝硬化、热泻、热淋、小便不利、 脚气、皮肤瘙痒、疥癣、水火烫伤、虫蛇咬伤。岗松油作为中药材标准,具有清热利湿、杀虫止痒之功效, 用于皮肤湿疹、瘙痒、淋病、疥疮、脚癣。此外岗松油还可作为香精、香料的使用。
有益效果:本发明无副作用,采用以上中药成分,能够有效修复阴道损伤,修复阴道的免疫力,对其 他妇科疾病具有辅助治疗;且制备方法稳定可行,适用于大量生产。本发明产品的效果优于同行业产品20 倍以上,具有消炎抑菌、杀虫止痒、修复受损组织以及提高女性性敏感度等良好效果。
具体实施方式
以下参照具体的实施例来说明本发明。本领域技术人员能够理解,这些实施例仅用于说明本发明,其 不以任何方式限制本发明的范围。
实施例1
称取称取1.5g壳聚糖、25g卡波姆、1.5g硫磺和0.01g岗松油,以及取白芨50g、大云30g、仙灵脾 20g、当归10g、紫草10g、蛇床子10g、苦参10g、肉桂5g、泽兰10g和血竭3g,制成外用凝胶剂。
具体过程如下:
(1)白芨、大云、仙灵脾、当归、紫草、蛇床子、苦参、肉桂、泽兰和血竭分别通过超生破壁层析 吸附技术提取其有效成分:将干燥的中药材连续三次超声破壁,获得药材超细粉;加入乙醇溶液,密封浸 泡2小时,超声波辅助下处理20分钟;然后搅拌浸提后离心,得到有效成分粗提物;将有效成分粗提物 pH值调至12左右,搅拌浸提3小时,离心去沉淀,上清液pH调至4.0-4.5;将得到的上清液经过大孔树 脂层析吸附;用20%乙醇溶液洗脱,得到含亚有效成分的醇溶液,用旋转蒸发仪进行浓缩,冷冻干燥,得 到有效成分提取物;
(2)按比例称取中药提取物自芨50g、大云30g、仙灵脾20g、当归10g、紫草10g、蛇床子10g、苦 参10g、肉桂5g、泽兰10g和血竭3g混合均匀,得到中药混合细粉;
(3)按比例称取1.5g壳聚糖、25g卡波姆和1.5g硫磺加180ml水混合,再加入0.01g的岗松油,混 合均匀,使其自然溶胀,得凝胶基质溶液,备用;
(3)将上述中药混合细粉加入至凝胶基质溶液,搅匀,加足量配有氢氧化钠的纯化水,便加边搅拌, 调整其pH值为5-7,搅匀即得凝胶产品;
(4)罐装成品:小管灌装,每支3克。
使用方法:
每天一支,睡前推入阴道深处;三个月为一个周期,一个周期即可达到最佳状态。
实施例2
称取称取1g壳聚糖、15g卡波姆、1g硫磺和0.0075g岗松油,以及取白芨40g、大云20g、仙灵脾15g、 当归8g、紫草8g、蛇床子8g、苦参8g、肉桂4g、泽兰8g和血竭2g,制成外用凝胶剂。具体制备方法和 使用方法同实施例1。
实施例3
称取称取2.5g壳聚糖、35g卡波姆、2.5g硫磺和0.02g岗松油,以及取白芨70g、大云50g、仙灵脾 30g、当归15g、紫草15g、蛇床子15g、苦参15g、肉桂8g、泽兰15g和血竭5g,制成外用凝胶剂。具体 制备方法和使用方法同实施例1。
实施例4
称取称取2g硫磺、2g壳聚糖、0.015g岗松油,以及取白芨60g、大云40g、仙灵脾25g、当归12g、 紫草12g、蛇床子12g、苦参12g、肉桂7g、泽兰12g和血竭3g,制成外用乳膏剂。
具体过程如下:
(1)同实施例1将白芨、大云、仙灵脾、当归、紫草、蛇床子、苦参、肉桂、泽兰通过超生破壁层 析吸附技术提取其有效成分提取物;按比例称取中药提取物白芨60g、大云40g、仙灵脾25g、当归12g、 紫草12g、蛇床子12g、苦参12g、肉桂7g、泽兰12g和血竭3g混合均匀,得到中药混合细粉;
(2)在上述中药混合细粉中加入500ml的纯化水,并加入2g硫磺、2g壳聚糖、0.015g岗松油,搅匀;
(3)收膏,加入真空乳化罐进行乳化45分钟;
(5)成品:乳化以后静置两小时即可罐装,罐装的裸支就是半成品;半成品再经过包装就是成品。
使用方法同实施例1。
典型案例:
周某某,女,32岁,顺产。24岁妊娠,由于新生儿偏大,导致顺产困难,经妇科检查发现阴道重度 损伤、撕裂。使用本实施例1产品三个月,阴道网状纤维和受损得到有效修复,阴道收缩压明显增强;并 继续使用1个月,完全修复。
王某某,女,42岁。多次怀孕流产,阴道松弛严重。使用本实施例1三个月,阴道松弛状态得到有效 修复,阴道收缩压明显增强。
芦某,女,41岁。产后阴道高度松弛,性冷淡,性快感缺失。使用本实施例2三个月,阴道松弛状态 得到有效修复,阴道收缩压明显增强,性冷淡以及性快感恢复正常。
尽管已经示出和描述了本发明的技术方案,对于本领域的普通技术人员而言,可以理解在不脱离本发 明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利 要求及其等同物限定。
Claims (8)
4.如权利要求1所述的用于修复阴道损伤的中药组合物,其特征在于,所述中药组合物的剂型为凝胶剂、或软膏剂。
5.如权利要求4所述的用于修复阴道损伤的中药组合物,其特征在于,所述中药组合物的剂型为凝胶剂。
6.如权利要求5所述的用于修复阴道损伤的中药组合物,其特征在于,所述凝胶剂中需再加入10~35份的卡波姆。
7.一种用于修复阴道损伤的中药组合物的制备方法,其特征在于,通过以下步骤:
(1)按比例称取1.5g壳聚糖、25g卡波姆和1.5g硫磺加180ml水混合,再加入0.01g的岗松油,混合均匀,使其自然溶胀,得凝胶基质溶液,备用;
(2)将白芨、大云、仙灵脾、当归、紫草、蛇床子、苦参、肉桂、泽兰和血竭通过超生破壁层析吸附技术提取其有效成分提取物;按比例称取中药提取物白芨50g、大云30g、仙灵脾20g、当归10g、紫草10g、蛇床子10g、苦参10g、肉桂5g、泽兰10g和血竭3g混合均匀,得到中药混合细粉;
(3)将上述中药混合细粉加入至凝胶基质溶液,搅匀,加足量配有氢氧化钠的纯化水,便加边搅拌,调整其pH值为5-7,搅匀即得凝胶产品;
(4)罐装成品:小管灌装,每支3克。
8.如权利要求7所述的用于修复阴道损伤的中药组合物的制备方法,其特征在于,所述超生破壁层析吸附技术:将干燥的中药材连续三次超声破壁,获得药材超细粉;加入乙醇溶液,密封浸泡2小时,超声波辅助下处理20分钟;然后搅拌浸提后离心,得到有效成分粗提物;将有效成分粗提物pH值调至12左右,搅拌浸提3小时,离心去沉淀,上清液pH调至4.0-4.5;将得到的上清液经过大孔树脂层析吸附;用20%乙醇溶液洗脱,得到含亚有效成分的醇溶液,用旋转蒸发仪进行浓缩,冷冻干燥,得到有效成分提取物。
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