CN115317657B - 一种黄连卫生巾的制备方法 - Google Patents
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Abstract
本发明提供一种黄连卫生巾的制备方法,包括以下步骤:称取黄连提取物与黄柏提取物配置成质量分数1~10%的混合溶液,然后添加质量分数0~2%的醋酸氯已定、0.001~0.1%的羧甲基纤维素钠,升温至40~100℃反应,得到总生物碱溶液;将载药巾浸泡于总生物碱溶液中,取出后干燥得到载药层;将载药层设置于卫生巾的表层与第二层之间形成黄连卫生巾。本发明使生物碱在卫生巾上起到很好的吸附固定作用,抑菌效果好。
Description
技术领域
本发明属于卫生用品技术领域,具体涉及一种黄连卫生巾的制备方法。
背景技术
我国调查数据显示,细菌性阴道炎在健康体检妇女中约占11%,在妇科门诊阴道炎症患者中占36~60%(欧阳振波,2021年中美细菌性阴道病诊治指南解读);宫颈炎是常见的妇科疾病之一,发病率高达25%~50%(汤兴丽,微波联合保妇康栓治疗慢性宫颈炎的临床疗效分析)。开发具有预防和保护妇科疾病的卫生产品,市场前景广阔。
黄连始载于《神农本草经》:“黄连:味苦寒。主热气,目痛,眦伤,泣出,明目(《御览》引云,主茎伤,《大观本》,无),肠澼,腹痛,下利,妇人阴中肿痛”。可见,自古以来就有黄连治疗妇科疾病的记载。现代药学研究发现黄连的主要活性成分是黄连生物检,黄连生物检具有广谱抗菌作用,同时具有良好的消炎、止痒、及治疗各种皮肤病的作用(《本草纲目》记载黄连治疗各种“无名肿毒”),“黄连是最好的抗菌药”(2010年3月24日,中医频道_凤凰网)。
现有技术中抑菌抗菌功能的卫生巾多为直接将中药粉末加入卫生巾,或者将中药提取物、中药浸膏混合后加入卫生巾,虽然所用中药混合物口服时具有很好的抗菌作用,但是用于卫生巾中抗菌效果不尽人意。如专利200510040252.8中公开了一种具有抑菌保健功能的卫生巾,将具有抑菌保健作用的的中药材提取液渗入卫生巾芯层,所用中药材包含有蛇床子16-17%、苦参14-15%、黄芩11-12%、黄柏11-12%、百部根9-10%、余量为益母草,将药物混合物用乙醇提取后直接渗入卫生巾芯层。专利201810299810.X中公开了一种用于卫生巾的抑菌中药组方及其制备方法,选用黄芩、黄连、艾叶、金银花、苦楝皮、苦参、花椒、蛇床子、土茯苓、白鲜皮、地肤子煎煮后制成浸膏添加到卫生巾中。但粉末、浸膏中草药直接添加后不溶解,难以到达卫生巾表层;而提取物药物在卫生巾上的固定能力差,在遇湿后药物会发生沉降、移动,卫生巾表层抑菌效果差。且黄连提取物在常温下为固体,水溶性差,在卫生巾中直接应用抑菌效果差。
发明内容
为了解决现有技术中的问题,本发明提供一种抑菌抗菌效果好的黄连卫生巾的制备方法。
本发明解决其技术问题是采用以下技术方案实现的:
本发明的目的在于提供一种黄连卫生巾的制备方法,其特征在于,包括以下步骤:
称取黄连提取物与黄柏提取物配置成质量分数1~10%的混合溶液,升温至40~100℃,然后添加质量分数0~2%的醋酸氯己定、0.001~0.1%的羧甲基纤维素钠,保温反应1-30分钟,得到总生物碱溶液;将载药巾浸泡于总生物碱溶液中,取出后干燥得到载药层;将载药层设置于卫生巾的表层与第二层之间形成黄连卫生巾。
进一步的,所述黄连提取物中总生物碱的含量大于50%,所述黄柏提取物中总生物碱的含量大于50%。
进一步的,所述总生物碱溶液为羧甲基纤维素-生物碱复合物溶液。
进一步的,所述黄连提取物与黄柏提取物的加入的质量比为2~8:2~8。
进一步的,所述黄连提取物与黄柏提取物的质量比为1:1。
进一步的,醋酸氯己定的添加量为总生物碱溶液质量的0.045~2%。
与现有技术相比,本发明的有益技术效果在于:
本发明黄连与黄柏的提取物与羧甲基纤维素钠高温时反应生成羧甲基纤维素-生物碱复合物,羧甲基纤维素-生物碱复合物与卫生巾表面的纤维相互结合,从而将生物碱均匀牢固的吸附在卫生巾载药层的表面。本发明羧甲基纤维素-生物碱复合物不影响原生物碱的基本结构,生物碱的抗菌抑菌效果不受影响,且对生物碱在卫生巾上起到很好的吸附固定作用,保证了使用过程中药物不发生沉降、移动,抑菌效果好。
上述说明仅是本发明技术方案的概述,为了能够更清楚了解本发明的技术手段,而可依照说明书的内容予以实施,并且为了让本发明的上述和其它目的、特征和优点能够更明显易懂,以下特举本发明的具体实施方式。
具体实施方式
以下结合具体实施例对本发明技术方案作进一步详细说明。应当理解,下列实施例仅为示例性地说明和解释本发明,而不应被解释为对本发明保护范围的限制。凡基于本发明上述内容所实现的技术均涵盖在本发明旨在保护的范围内。
另外,除非另有特别说明,本发明中用到的各种原材料、试剂、仪器和设备均可通过市场购买获得或现有方法制备得到。本发明中使用的市售黄连提取物购自重庆伊士腾生物科技有限公司(生产批号:20220322),黄柏提取物购自购自重庆伊士腾生物科技有限公司(生产批号:20220412)。
实施例1:
黄柏20g、黄连79.9g、羧甲基纤维素钠0.1g。黄柏和黄连混合粉碎,然后用0.5%的硫酸渗漉提取至渗漉液为浅黄色;用石灰中和渗漉液到溶液的pH为5.0,过滤,滤液减压浓缩到100mL;浓缩液静止冷却,过滤;滤液用10%的氯化钠和0.5%的氯化锌盐析,过滤,沉淀用20ml水洗涤一次,干燥以后,得到总生物碱10g;HPLC分析含量:小檗碱46.8%、黄连碱11.5%、巴马汀10.8%、表小檗碱5.7%,总生物碱含量74.9%;总生物碱溶于适量水中,添加0.01g羧甲基纤维素钠,定容到100mL,使黄连总生物碱的质量百分含量为10%。升温到100℃,将适量载药巾放于溶液中,溶液刚好被载药巾吸完,1分钟以后,取出,80℃下烘干得到载药层;将烘干以后的载药层剪裁为适当的尺寸,添加于卫生巾的表层与第二层之间,即为黄连卫生巾。
实施例2:
称取市售黄连提取物2g与黄柏提取物6g,混合后用HPLC分析含量:小檗碱59.76%、黄连碱5.2%、巴马汀4.8%、表小檗碱2.6%,总生物碱含量72.3%;将总生物碱溶于适量水中,添加0.001g羧甲基纤维素钠,0.16g醋酸氯己定,定容到800mL,使总生物碱的质量百分含量为1%。升温到40℃,将适量载药巾放于溶液中,溶液刚好被载药巾吸完,1分钟以后,取出,80℃下烘干得到载药层;将烘干以后的载药层剪裁为适当的尺寸,添加于卫生巾的表层与第二层之间,即为黄连卫生巾。
实施例3:
称取市售黄连提取物4.5g与黄柏提取物4.5g,混合后用HPLC分析含量:小檗碱52.2%、黄连碱8.8%、巴马汀8.2%、表小檗碱4.4%,总生物碱含量73.6%;将总生物碱溶于适量水中,添加0.045g醋酸氯己定,0.01g羧甲基纤维素钠,定容到180mL,使总生物碱的质量百分含量为5%。升温到70℃,将适量载药巾放于溶液中,溶液刚好被载药巾吸完,1分钟以后,取出,80℃下烘干得到载药层;将烘干以后的载药层剪裁为适当的尺寸,添加于卫生巾的表层与第二层之间,即为黄连卫生巾。
实验例1:
称取0.1g羧甲基纤维素钠溶于50mL水中,升温到80℃。将实施例3中制备的总生物碱添加到50mL水中,升温到80℃,溶解以后;搅拌下将两种溶液混合,充分反应10分钟;然后溶液降温冷却到室温,析出沉淀,过滤后,蒸馏水淋洗沉淀,得到羧甲基纤维素小檗碱复合物。利用原子吸收技术检测钠离子含量:总生物碱(实施例3)中钠离子含量为0.5%,羧甲基纤维素钠溶液中钠离子含量为21.5%,羧甲基纤维素小檗碱复合物中钠离子含量0.001%。因此可以看出本发明实施例中反应得到的羧甲基纤维素小檗碱复合物不含有钠离子。
由此可以看出,黄连生物碱与羧甲基纤维素钠在加热条件下反应合成羧甲基纤维素-生物碱复合物,从而增强生物碱药物组合物与卫生巾的吸附作用,抑菌效果更好。
实验例2:抑菌效果
对比例1:按照实施例1的配方,制备工艺,制备黄连卫生巾。但是总生物碱溶液的浓度为5%的溶液(即10g总生物碱溶于200mL溶液中),其余所有参数和操作步骤与实施例1相同。
对比例2:按照实施例2的配方,制备工艺,制备黄连卫生巾。但是总生物碱溶液的浓度为5%的溶液(即8g总生物碱溶于160mL溶液中),其余所有参数和操作步骤与实施例1相同。
对比例3:称取实施例3中使用的市售黄连提取物4.5g与黄柏提取物4.5g,添加0.045g醋酸氯己定,溶于水配置为总生物碱浓度5%的溶液,并将溶液升温至70℃使总生物碱溶解,取与实验例3相同的载药巾浸泡于溶液中,1分钟后取出,80℃下干燥备用。
对本发明实施例3及对比例进行抑菌效果实验,具体步骤如下:
选用金黄色葡萄球菌(S.aureus)、白色念珠菌(C.albicans)和大肠杆菌(E.coli)为试验菌种,采用纸片法进行抑菌效果的检测:用制备的固体培养基制备相应菌种用平板,恒温箱培养24h,检验无杂菌污染后备用。在无菌条件下用灭菌后的移液枪及枪头吸取菌液1mL置于相应平板,用灭菌后的玻璃涂布环将菌液均匀涂散于固体琼脂平板上进行接种,然后将制备好的药物纸片(Φ8mm)贴于平板上,每个平板放置3个含药纸片,每种药物对一种试验菌的实验重复两个平板。处理好的平板培养条件分别为细菌37℃/24h(脓肿分枝杆菌37℃/48h),真菌为25℃/48h,培养结束后用游标卡尺从培养皿的背面量取并记录抑菌圈直经,记录单位为mm。通过观察抑菌圈的大小初步判断和比较药物对不同微生物的敏感性及其相对抑制活性。见表1。
表1抑菌效果对比(抑菌圈直径:mm)
可以看出,本发明卫生巾对多种微生物如金色葡萄球菌、白色念珠菌、大肠杆菌都有很好的抗菌效果。对比例与实施例3具有相似的抗菌活性,将对比例3与实施例3对比发现,本发明中将总生物碱制成羧甲基纤维素小檗碱复合物后与总生物碱具有相似的抗菌活性,抗菌抑菌效果不会下降。参见对比例1,不添加醋酸氯己定后抑菌圈略小于其他组,通过对比例1、对比例2、实施例3进行对比发现,随着醋酸氯己定的增加,抗菌活性有进一步提高的趋势,醋酸氯己定在本发明中起到稳定和辅助杀菌的作用,使卫生巾的抗菌抑菌效果更加稳定。
实验例3:制备工艺对抑菌效果的影响
对比例4:与本发明实施例3所不同的是,不添加羧甲基纤维素钠,升温至70℃,将适量载药巾放于溶液中,溶液刚好被载药巾吸完,1分钟以后,取出,80℃下烘干得到载药层;将烘干以后的载药层剪裁为适当的尺寸,添加于卫生巾的表层与第二层之间,得到黄连卫生巾。
对比例5:与本发明实施例3所不同的是,添加0.01%羧甲基纤维素钠后,直接将适量载药巾放于溶液中,溶液刚好被载药巾吸完,1分钟以后,取出,80℃下烘干得到载药层;将烘干以后的载药层剪裁为适当的尺寸,添加于卫生巾的表层与第二层之间,得到黄连卫生巾。
对比例6:称量小檗碱9g溶于适量水中,然后添加0.01g羧甲基纤维素钠,0.045g醋酸氯己定,定容到180mL,升温到70℃,将适量载药巾放于溶液中,溶液刚好被载药巾吸完,1分钟以后,取出,80℃下烘干得到载药层;将烘干以后的载药层剪裁为适当的尺寸,添加于卫生巾的表层与第二层之间,得到黄连卫生巾。
对比例7:按照专利200510040252.8的方法进行制备,蛇床子17g、苦参15g、黄芩12g、黄柏12g、百部根10g、益母草34g。用800ml80%浓度的医用乙醇混合,浸渍至少2天,然后加热回流提取,提取液中添加25g冰片,回收溶剂,得到提取物60g,将提取物渗入载药层后干燥作为载药层,得到卫生巾。
对比例8:市售白云山卫生巾。
对本发明实施例3与对比例4-8得到的卫生巾,取出各实施例及对比例的载药层,按照《一次性使用卫生用品卫生标》,GB15979-2002.标准进行检测,具体方法如下:
1)实验菌株:金黄色葡萄球菌(ATCC 6538),大肠杆菌(8099或ATCC 25922)。2)酵母菌:白色念珠菌(ATCC 10231)。3)、菌液制备:取菌株第3~14代的营养琼脂培养基斜面新鲜培养物(18~24h),用5mL0.03mol/L磷酸盐缓冲液(以下简称PBS)洗下菌苔,使菌悬浮均匀后用上述PBS稀释至所需浓度。4)抑菌试验:将试验菌24h斜面培养物用PBS洗下,制成菌悬液(要求的浓度为:用100μL滴于对照样片上或5mL样液内,回收菌数为1×104~9×104cfu/片或mL);取被试样片(2.0cm×3.0cm)和对照样片(与试样同质材料,同等大小,但不含抗菌材料,且经灭菌处理)各4片(置于灭菌平皿内)。取上述菌悬液,分别在每个被试样片和对照样片上滴加100μL,均匀涂布,开始计时,作用2、5、10、20min,用无菌镊分别将样片投入含5mLPBS的试管内,充分混匀,作适当稀释,然后取其中2~3个稀释度,分别吸取0.5mL,置于两个平皿,用凉至40~45℃的营养琼脂培养基(细菌)或沙氏琼脂培养基(酵母菌)15mL作倾注,转动平皿,使其充分均匀,琼脂凝固后翻转平板,35℃±2℃培养48h(细菌)或72h(酵母菌),作活菌菌落计数。5)计算抑菌率:X4=(A-B)/A×100%;式中:X4――抑菌率%;A――对照样品平均菌落数;B――被试样品平均菌落数。6)、评价标准:抑菌率≥50%~90%,产品有抑菌作用,抑菌率≥90%,产品有较强抑菌作用。结果见表2。
表2抑菌率对比(%)
可以看出,本发明产品对金色葡萄球菌、白色念珠菌、大肠杆菌都有较好的抑菌、杀菌效果,抑菌率超过90%。对比例4由于不添加羧甲基纤维素钠,药物与载药层的吸附能力差,在操作过程中尤其是干燥中药物容易脱落,从而影响抑菌效果。对比例5虽然添加了羧甲基纤维素钠,但是没有升温,从而导致羧甲基纤维素钠与生物碱反应不完全,同样难以吸附在载药层上,而且由于实验中不升温,生物碱的溶解度低,使得吸取药物过程中部分药物难以附着在载药层上,从而导致对比例5的抑菌率较对比例4差。对比例6采用小檗碱作为原料,虽然对金色葡萄球菌、大肠杆菌具有较好的抗菌效果,但对白色念珠菌抗菌效果较差。对比例7及对比例8虽然有一定的抑菌作用,但抑菌作用较差。
实验例4:
将实施例3中的实施例3与对比例4方法中取出的载药层,各分为大小、形状一致的两块,分别将实施例3与对比例4各一块放于100mL清水中,搅拌漂洗1分钟,过滤;再添加100mL清水,搅拌漂洗1分钟,过滤,干燥。然后将四块载药层分别放于100mL甲醇溶液中,搅拌10分钟,过滤;溶液回收溶剂,溶于5mL甲醇中,过滤。用HPLC分析生物碱含量,实验结果见表3。
表3样本中生物碱含量(%)
可以看出,本发明卫生巾即使在清水中漂洗1分钟后,仍然含有大量的生物碱,而不添加羧甲基纤维素钠的样品漂洗后几乎不含生物碱,可见添加羧甲基纤维素钠后大大增强了生物碱在卫生巾上的吸附能力。防止卫生巾在加工过程中,或者使用者在使用过程中药物沉降、移动,从而影响药物的效果,降低卫生巾抑菌作用。
实验例5:
对比例9:将实施例3中的载药巾换为尼龙布,其余操作相同。
将对比例9的尼龙布分为大小、形状一致的两块,并将其中一块放于100mL清水中,搅拌漂洗1分钟,过滤;再添加100mL清水,搅拌漂洗1分钟,过滤,干燥。然后将两块尼龙布分别放于100mL甲醇溶液中,搅拌10分钟,过滤;溶液回收溶剂,溶于5mL甲醇中,过滤。用HPLC分析生物碱含量,实验结果见表4。
表4样本中生物碱含量(%)
可以看到,对比例9与表3中本申请实施例3相比,本产品更容易吸附于“纤维素”载体,而对于尼龙等非纤维素类载体吸附能力较差。这与“相似相容”的吸附原理有关。
上述本发明实施例序号仅仅为了描述,不代表实施例的优劣。
上面对本发明的实施例进行了描述,但是本发明并不局限于上述的具体实施方式,上述的具体实施方式仅仅是示意性的,而不是限制性的,本领域的普通技术人员在本发明的启示下,在不脱离本发明宗旨和权利要求所保护的范围情况下,还可做出很多形式,这些均属于本发明的保护之内。
Claims (1)
1.一种黄连卫生巾的制备方法,其特征在于,包括以下步骤:
称取黄连提取物4.5g与黄柏提取物4.5g,混合后用HPLC分析含量:小檗碱52.2%、黄连碱8.8%、巴马汀8.2%、表小檗碱4.4%,总生物碱含量73.6%;将总生物碱溶于适量水中,添加0.045g醋酸氯己定,0.01g羧甲基纤维素钠,定容到180mL,使总生物碱的质量百分含量为5%;升温到70℃,将适量载药巾放于溶液中,溶液刚好被载药巾吸完,1分钟以后,取出,80℃下烘干得到载药层;将烘干以后的载药层剪裁为适当的尺寸,添加于卫生巾的表层与第二层之间,即为黄连卫生巾。
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CN101269132A (zh) * | 2008-05-14 | 2008-09-24 | 西南大学 | 一种黄连总生物碱提取工艺 |
CN109876176A (zh) * | 2019-02-22 | 2019-06-14 | 泉州市洛江区汇丰妇幼用品有限公司 | 一种中药抑菌卫生巾 |
CN112442921A (zh) * | 2019-09-04 | 2021-03-05 | 中国制浆造纸研究院有限公司 | 一种纸基功能材料及其制备方法 |
CN112717088A (zh) * | 2020-11-12 | 2021-04-30 | 上海中医药大学附属曙光医院 | 一种中药组合物、药物制剂及其制备方法和应用 |
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CN101269132A (zh) * | 2008-05-14 | 2008-09-24 | 西南大学 | 一种黄连总生物碱提取工艺 |
CN109876176A (zh) * | 2019-02-22 | 2019-06-14 | 泉州市洛江区汇丰妇幼用品有限公司 | 一种中药抑菌卫生巾 |
CN112442921A (zh) * | 2019-09-04 | 2021-03-05 | 中国制浆造纸研究院有限公司 | 一种纸基功能材料及其制备方法 |
CN112717088A (zh) * | 2020-11-12 | 2021-04-30 | 上海中医药大学附属曙光医院 | 一种中药组合物、药物制剂及其制备方法和应用 |
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