CN117018134A - 一种用于男女阴部清洁的中药组合物及其制备方法和应用 - Google Patents
一种用于男女阴部清洁的中药组合物及其制备方法和应用 Download PDFInfo
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Abstract
本发明提供了一种用于男女阴部清洁的中药组合物及其制备方法和应用,属于中药组合物技术领域。本发明的用于男女阴部清洁的中药组合物,由包括如下重量份的原料制备而成:夏枯草20~45份、百合15~30份、小茴香6~10份、白芷6~10份、薄荷8~14份、金银花10~15份、黄芪3~6份、荷叶3~6份、高良姜3~6份。本发明的中药组合物温和不刺激,能够有效抑制男女阴部有害细菌,同时保证有益菌群的数量和活性,提高机体免疫力和自洁能力,减少药物对人体的二次伤害。
Description
技术领域
本发明涉及中药组合物技术领域,尤其涉及一种用于男女阴部清洁的中药组合物及其制备方法和应用。
背景技术
由于生理原因,女性外阴部位皮肤非常娇嫩,皮肤汗腺丰富,皱褶多,隐蔽不暴露,透气性差,最容易被病菌攻击。女性的生殖器、腹腔与外界是相通的,这是女性生殖器的独特之处,病菌可由阴道进入子宫。而男性由于阴部包皮过长,包皮的分泌物容易积聚在包皮腔内,不能及时的排出或清洁,会导致私处感染,从而引发包皮龟头炎等疾病。通常情况下,女性阴道内有大量的乳酸杆菌,它分解糖原产生乳酸,使阴道内呈酸性环境,不利于有害菌的生长。男性阴部也含有一定的有益菌群,能够抑制有害菌。在局部抵抗力下降时,有些病菌和病原体就会乘虚而入。
市面上的阴部清洁剂主要是改变阴部的内环境,改变酸碱度,抑制细菌的生长繁殖,同时可以起到消炎作用,有助于局部的炎症得到消除。但用于治疗阴部疾病的药剂并不适合日常使用,容易造成过度清洁,阴道的酸碱环境被破坏,菌群失调,免疫力下降,外来有害细菌入侵,反而加重病症。而日常使用的清洁剂清洁力度不够,难以有效抑制疾病的发生。
发明内容
本发明的目的在于提供一种用于男女阴部清洁的中药组合物及其制备方法和应用。本发明的中药组合物温和不刺激,能够有效抑制男女阴部有害细菌,同时保证有益菌群的数量和活性,提高机体免疫力和自洁能力,减少药物对人体的二次伤害。
为了实现上述发明目的,本发明提供以下技术方案:
本发明提供了一种用于男女阴部清洁的中药组合物,由包括如下重量份的原料制备而成:夏枯草20~45份、百合15~30份、小茴香6~10份、白芷6~10份、薄荷8~14份、金银花10~15份、黄芪3~6份、荷叶3~6份、高良姜3~6份。
本发明还提供了一种上述中药组合物的制备方法,包括如下步骤:
(1)将夏枯草、小茴香、薄荷、黄芪混合粉碎后,加入乙醇溶液回流,得到中药醇提物;
(2)将百合、白芷、金银花、荷叶、高良姜混合粉碎后,加水煎煮,过滤,得到中药水提物;
(3)将所述中药醇提物与所述中药水提物混合,得到所述中药组合物。
优选的,步骤(1)中所述夏枯草、小茴香、薄荷、黄芪粉碎后的粒径为30~50目。
优选的,所述乙醇溶液的添加量为所述夏枯草、小茴香、薄荷、黄芪总重量的5~20倍,所述乙醇溶液的体积分数为90~95%。
优选的,所述回流的温度为65~80℃,所述回流的次数为2~3次,所述回流的时间每次为1~2h。
优选的,所述回流结束后,合并提取液,浓缩,得到中药醇提物;所述浓缩至80℃时密度为1.02~1.15g/ml。
优选的,步骤(2)中所述百合、白芷、金银花、荷叶、高良姜粉碎后的粒径为10~20目。
优选的,所述水的添加量为所述百合、白芷、金银花、荷叶、高良姜总重量的8~15倍。
优选的,所述煎煮的时间为2~4h。
本发明还提供了一种上述中药组合物在制备男女阴部清洁剂中的应用。
本发明提供了一种用于男女阴部清洁的中药组合物及其制备方法和应用。本发明中的夏枯草归肝、胆经,具有清肝泻火,明目,散结消肿的功效;百合养阴润肺,清心安神,主阴虚久嗽,失眠多梦、精神恍惚,具备镇咳祛痰、镇静、滋阴润肺、强壮和抗癌等功效;小茴香味辛,性温,归肝、肾、膀胱经,具有散寒止痛、理气和胃的功效,可用于治疗寒疝腹痛、睾丸肿痛、痛经、月经不调、脘腹胀痛等病症;白芷味辛、性温,入肺、脾、胃经,有解表散寒、祛风止痛、通鼻窍、燥湿止带、消肿排脓、祛风止痒的功效;薄荷辛凉,发汗解热,可治流行性感冒、头疼、目赤、身热、咽喉、牙床肿痛等症,外用可治神经痛、皮肤瘙痒、皮疹和湿疹等;金银花性甘寒,清热解毒、消炎退肿,主温病发热、热毒血痢、痈肿疔疮、喉痹及多种感染性疾病;黄芪味甘,性微温,具补气固表、利尿、强心、降压、抗菌、托毒、排脓、生肌、加强毛细血管抵抗力、止汗和类性激素的功效,治表虚自汗、气虚内伤、脾虚泄泻、浮肿及痈疽等;荷叶归肝、脾、胃经,主要有清热解暑,升发清阳,散瘀止血的功效,用于暑热烦渴,暑湿泄泻,脾虚泄泻,血热吐衄,便血崩漏;高良姜味辛,性热,温中散寒,理气止痛。本发明所用原料均为药食同源目录中的原料,更为安全。
本发明采用乙醇溶液回流的方法制备夏枯草、小茴香、薄荷、黄芪的醇提物,采用煎煮的方法制备百合、白芷、金银花、荷叶、高良姜中的水提物,对不同药物中的有效成分进行针对性的提取,使组合物中有效成分更具抑菌活性。本发明的中药组合物对阴部常见的金黄色葡萄球菌、白色念珠菌、溶血性链球菌等均有显著的抑制作用,而对阴部的有益菌嗜酸乳杆菌的影响较小,有利于维护阴部有益菌群平衡,保证人体的自洁能力和免疫力。
具体实施方式
本发明提供了一种用于男女阴部清洁的中药组合物,由包括如下重量份的原料制备而成:夏枯草20~45份、百合15~30份、小茴香6~10份、白芷6~10份、薄荷8~14份、金银花10~15份、黄芪3~6份、荷叶3~6份、高良姜3~6份。
在本发明中,所述中药组合物优选由包括如下重量份的原料制备而成:夏枯草20~45份、百合15~30份、小茴香6~10份、白芷6~10份、薄荷8~14份、金银花10~15份、黄芪3~6份、荷叶3~6份、高良姜3~6份;进一步优选由包括如下重量份的原料制备而成:夏枯草35份、百合25份、小茴香8份、白芷8份、薄荷10份、金银花12份、黄芪5份、荷叶5份、高良姜5份。
本发明还提供了一种上述中药组合物的制备方法,包括如下步骤:
(1)将夏枯草、小茴香、薄荷、黄芪混合粉碎后,加入乙醇溶液回流,得到中药醇提物;
(2)将百合、白芷、金银花、荷叶、高良姜混合粉碎后,加水煎煮,过滤,得到中药水提物;
(3)将所述中药醇提物与所述中药水提物混合,得到所述中药组合物。
本发明将夏枯草、小茴香、薄荷、黄芪混合粉碎后,加入乙醇溶液回流,得到中药醇提物。
在本发明中,所述夏枯草、小茴香、薄荷、黄芪粉碎后的粒径优选为30~50目,进一步优选为30目。
在本发明中,所述乙醇溶液的添加量优选为所述夏枯草、小茴香、薄荷、黄芪总重量的5~20倍,进一步优选为15倍。
在本发明中,所述乙醇溶液的体积分数优选为90~95%,进一步优选为95%。
在本发明中,所述回流的温度优选为65~80℃,进一步优选为70℃。
在本发明中,所述回流的次数优选为2~3次,进一步优选为2次。
在本发明中,所述回流的时间优选每次1~2h,进一步优选每次1.5h。
在本发明中,所述回流结束后,优选合并提取液,浓缩,得到中药醇提物。
在本发明中,所述浓缩优选浓缩至80℃时密度为1.02~1.15g/ml,进一步优选浓缩至80℃时密度为1.10g/ml。
在本发明中,本发明将百合、白芷、金银花、荷叶、高良姜混合粉碎后,加水煎煮,过滤,得到中药水提物。
在本发明中,在本发明中,步骤(2)中所述百合、白芷、金银花、荷叶、高良姜粉碎后的粒径优选为10~20目,进一步优选为10目。
在本发明中,所述水的添加量优选为所述百合、白芷、金银花、荷叶、高良姜总重量的8~15倍,进一步优选为10倍。
在本发明中,所述煎煮的时间优选为2~4h,进一步优选为3h。
本发明将所述中药醇提物与所述中药水提物混合,得到所述中药组合物。
本发明还提供了一种上述中药组合物在制备男女阴部清洁剂中的应用。
下面结合实施例对本发明提供的技术方案进行详细的说明,但是不能把它们理解为对本发明保护范围的限定。
实施例1
本实施例提供了一种用于男女阴部清洁的中药组合物,包括夏枯草35份、百合25份、小茴香8份、白芷8份、薄荷10份、金银花12份、黄芪5份、荷叶5份、高良姜5份。
具体制备过程如下:
(1)将夏枯草、小茴香、薄荷、黄芪混合后,粉碎成30目,加入870份的95%乙醇溶液,于70℃下回流2次,每次1.5h,回流结束后,合并提取液,浓缩至密度为1.10g/ml(80℃),得到中药醇提物;
(2)将百合、白芷、金银花、荷叶、高良姜混合后,粉碎成10目,加入550份的水,采用文火煎煮3h,煎煮结束后,过滤,得到得到中药水提物;
(3)将中药醇提物与中药水提物混合,得到所述中药组合物。
实施例2
本实施例提供了一种用于男女阴部清洁的中药组合物,包括夏枯草20份、百合30份、小茴香10份、白芷10份、薄荷14份、金银花15份、黄芪3份、荷叶3份、高良姜6份。
具体制备过程如下:
(1)将夏枯草、小茴香、薄荷、黄芪混合后,粉碎成30目,加入940份的90%乙醇溶液,于65℃下回流2次,每次2h,回流结束后,合并提取液,浓缩至密度为1.15g/ml(80℃),得到中药醇提物;
(2)将百合、白芷、金银花、荷叶、高良姜混合后,粉碎成20目,加入960份的水,采用文火煎煮4h,煎煮结束后,过滤,得到得到中药水提物;
(3)将中药醇提物与中药水提物混合,得到所述中药组合物。
实施例3
本实施例提供了一种用于男女阴部清洁的中药组合物,包括夏枯草45份、百合15份、小茴香6份、白芷6份、薄荷8份、金银花10份、黄芪6份、荷叶6份、高良姜3份。
具体制备过程如下:
(1)将夏枯草、小茴香、薄荷、黄芪混合后,粉碎成50目,加入650份的95%乙醇溶液,于80℃下回流3次,每次1h,回流结束后,合并提取液,浓缩至密度为1.02g/ml(80℃),得到中药醇提物;
(2)将百合、白芷、金银花、荷叶、高良姜混合后,粉碎成20目,加入320份的水,采用文火煎煮2h,煎煮结束后,过滤,得到得到中药水提物;
(3)将中药醇提物与中药水提物混合,得到所述中药组合物。
对比例1
本对比例与实施例1的区别在于,省略夏枯草和百合。
对比例2
本对比例与实施例1的区别在于,省略小茴香和白芷。
对比例3
本对比例与实施例1的区别在于,将夏枯草替换为苦参,将高良姜替换为生姜。
对比例4
本对比例与实施例1的区别在于,将夏枯草、小茴香、薄荷、黄芪混合与百合、白芷、金银花、荷叶、高良姜混合,采用步骤(1)的方法处理,得到中药醇提物,将中药醇提物与550份的水混合,得到中药组合物。
对比例5
本对比例与实施例1的区别在于,将夏枯草、小茴香、薄荷、黄芪混合与百合、白芷、金银花、荷叶、高良姜混合,采用步骤(2)的方法处理,得到中药组合物。
试验例1
本试验例对实施例1~3、对比例1~5的中药组合物的功效和安全性进行了验证,具体过程如下:
(1)抑菌实验
试验菌种为金黄色葡萄球菌、白色念珠菌、溶血性链球菌、嗜酸乳杆菌。将各菌种制成菌落数为104cfu/ml的菌悬液。将5ml的菌悬液分别与1ml的对照组(水)、实施例1、实施例2、实施例3、对比例1、对比例2、对比例3、对比例4、对比例5、现有技术(质量浓度为0.1%的苯扎溴铵溶液)混匀,于200rpm下培养。分别在培养至3min、5min、10min时取0.2ml菌悬液进行菌种计数,根据公式1计算抑菌率。各组抑菌率计算结果如表1~4所示。
公式1:抑菌率%=(对照组-实验组)/对照组×100%
表1各组药物对金黄色葡萄球菌的抑菌率
组别 | 2min | 5min | 10min |
实施例1 | 95.6 | 98.5 | 98.9 |
实施例2 | 94.3 | 96.8 | 98.7 |
实施例3 | 94.1 | 97.1 | 97.3 |
对比例1 | 62.7 | 74.5 | 88.0 |
对比例2 | 77.0 | 81.3 | 84.2 |
对比例3 | 88.9 | 92.1 | 94.6 |
对比例4 | 86.5 | 94.3 | 95.9 |
对比例5 | 89.8 | 94.2 | 94.7 |
现有技术 | 98.6 | 100 | 100 |
表2各组药物对白色念珠菌的抑菌率
组别 | 2min | 5min | 10min |
实施例1 | 90.6 | 94.5 | 96.1 |
实施例2 | 89.0 | 94.8 | 95.8 |
实施例3 | 89.6 | 93.9 | 95.9 |
对比例1 | 55.4 | 67.8 | 79.1 |
对比例2 | 56.8 | 66.3 | 67.3 |
对比例3 | 77.9 | 82.4 | 93.6 |
对比例4 | 89.4 | 96.7 | 98.6 |
对比例5 | 86.5 | 92.7 | 94.1 |
现有技术 | 98.5 | 100 | 100 |
表3各组药物对溶血性链球菌的抑菌率
表4各组药物对嗜酸乳杆菌的抑菌率
组别 | 2min | 5min | 10min |
实施例1 | 21.6 | 27.1 | 32.5 |
实施例2 | 19.6 | 26.1 | 33.0 |
实施例3 | 20.5 | 28.4 | 29.8 |
对比例1 | 14.3 | 16.5 | 24.3 |
对比例2 | 12.9 | 17.3 | 22.1 |
对比例3 | 18.4 | 25.3 | 29.4 |
对比例4 | 20.0 | 26.6 | 27.5 |
对比例5 | 19.4 | 29.1 | 31.7 |
现有技术 | 68.4 | 78.4 | 85.2 |
从表1~4可以看出,实施例1~3的中药组合物能够有效抑制金黄色葡萄球菌、白色念珠菌、溶血性链球菌,尤其对溶血性链球菌的抑制作用,与现有技术中的化学药剂相近,但对乳酸杆菌等益生菌影响较小。表明本发明的中药组合物能够对阴部有害细菌产生显著的抑制作用,但不破坏阴部有益菌群平衡,有助于维持阴部自洁能力和免疫力。相比实施例1~3,对比例1~2的中药组合物省略了部分原料,抑菌率下降;对比例3的中药组合物替换了某些原料,也会造成抑菌率下降;对比例4和5的中药组合物中,所有原料均采用相同的制备方法,也造成了抑菌率下降。
(2)毒性实验
选择体重为240±20g的雌性大鼠45只,随机分成9组,每组5只,分别为空白对照组、实施例1组、实施例2组、实施例3组、对比例1组、对比例2组、对比例3组、对比例4组、对比例5组。空白对照组按照2ml/kg体重的剂量,给予大鼠阴道生理盐水,其他各组按照同样剂量,分别给予大鼠对应组别的药物,每日用药一次。在给药前、给药1天、3天、10天时,对大鼠进行血液学指标和血液生化指标检测,检测结果如表5~8所示。
表5各组大鼠血液红细胞数量的变化(×1012/L)
组别 | 给药前 | 给药1天 | 给药3天 | 给药10天 |
对照组 | 8.7 | 8.9 | 8.9 | 8.7 |
实施例1 | 8.5 | 8.6 | 8.4 | 8.4 |
实施例2 | 8.8 | 8.5 | 8.3 | 8.4 |
实施例3 | 8.7 | 8.5 | 8.5 | 8.6 |
对比例1 | 8.5 | 8.4 | 8.7 | 8.5 |
对比例2 | 8.8 | 8.6 | 8.5 | 8.3 |
对比例3 | 8.8 | 8.7 | 8.5 | 8.3 |
对比例4 | 8.7 | 8.4 | 8.3 | 8.2 |
对比例5 | 8.5 | 8.3 | 8.3 | 8.1 |
表6各组大鼠血液白细胞数量的变化(×109/L)
组别 | 给药前 | 给药1天 | 给药3天 | 给药10天 |
对照组 | 4.7 | 4.8 | 4.7 | 4.6 |
实施例1 | 4.6 | 4.8 | 4.9 | 4.5 |
实施例2 | 4.6 | 4.6 | 4.5 | 4.6 |
实施例3 | 4.8 | 4.5 | 4.8 | 4.9 |
对比例1 | 4.9 | 4.8 | 4.6 | 47 |
对比例2 | 4.5 | 4.2 | 4.3 | 4.5 |
对比例3 | 5.0 | 4.7 | 4.7 | 4.5 |
对比例4 | 4.6 | 4.4 | 4.5 | 4.8 |
对比例5 | 4.8 | 4.6 | 4.7 | 4.5 |
表7各组大鼠血液生化指标AST和ALT的变化(U/L)
表8各组大鼠血液生化指标BUN(mmol/L)和crea(μmol/L)的变化
从表5~6可以看出,与空白对照组相比,实施例1~3、对比例1~5的中药组合物对大鼠的血液中红细胞和白细胞数量无明显影响。从表7~8可以看出,与空白对照组相比,实施例1~3、对比例1~5的中药组合物对大鼠的血液中AST、ALT、BUN和crea的检测结果也无明显影响。表明,本发明的中药组合物生物相容性好,无毒副作用,可放心使用。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进和润饰,这些改进和润饰也应视为本发明的保护范围。
Claims (10)
1.一种用于男女阴部清洁的中药组合物,其特征在于,由包括如下重量份的原料制备而成:夏枯草20~45份、百合15~30份、小茴香6~10份、白芷6~10份、薄荷8~14份、金银花10~15份、黄芪3~6份、荷叶3~6份、高良姜3~6份。
2.一种权利要求1所述中药组合物的制备方法,其特征在于,包括如下步骤:
(1)将夏枯草、小茴香、薄荷、黄芪混合粉碎后,加入乙醇溶液回流,得到中药醇提物;
(2)将百合、白芷、金银花、荷叶、高良姜混合粉碎后,加水煎煮,过滤,得到中药水提物;
(3)将所述中药醇提物与所述中药水提物混合,得到所述中药组合物。
3.根据权利要求2所述的制备方法,其特征在于,步骤(1)中所述夏枯草、小茴香、薄荷、黄芪粉碎后的粒径为30~50目。
4.根据权利要求3所述的制备方法,其特征在于,所述乙醇溶液的添加量为所述夏枯草、小茴香、薄荷、黄芪总重量的5~20倍,所述乙醇溶液的体积分数为90~95%。
5.根据权利要求4所述的制备方法,其特征在于,所述回流的温度为65~80℃,所述回流的次数为2~3次,所述回流的时间每次为1~2h。
6.根据权利要求5所述的制备方法,其特征在于,所述回流结束后,合并提取液,浓缩,得到中药醇提物;所述浓缩至80℃时密度为1.02~1.15g/ml。
7.根据权利要求6所述的制备方法,其特征在于,步骤(2)中所述百合、白芷、金银花、荷叶、高良姜粉碎后的粒径为10~20目。
8.根据权利要求7所述的制备方法,其特征在于,所述水的添加量为所述百合、白芷、金银花、荷叶、高良姜总重量的8~15倍。
9.根据权利要求8所述的制备方法,其特征在于,所述煎煮的时间为2~4h。
10.一种权利要求1所述的中药组合物或权利要求2~9任一项所述制备方法制得的中药组合物在制备男女阴部清洁剂中的应用。
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