CN111358819A - 一种具有抗菌止血作用的中药组合物 - Google Patents
一种具有抗菌止血作用的中药组合物 Download PDFInfo
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Abstract
本发明公开了一种具有抗菌止血作用的中药组合物,该组合物的成分包含平卧菊三七提取物与马齿苋提取物。该产品安全有效,在日常使用中,既能利用平卧菊三七的止血作用达到抑制出血的作用,又能发挥马齿苋的抗菌作用,达到对牙齿与口腔的双重保健效果,且本发明设计的是一种对牙齿与口腔具有抗菌止血作用的可长期使用的中药组合物,以避免出现像抗生素等产生的耐药性问题。
Description
技术领域
本发明属于口腔卫生技术领域,具体涉及一种抗菌止血的中药组合物及其制备方法。
背景技术
口腔健康是人体健康的重要组成部分。“现代中国人口腔健康主要有七大问题,包括龋齿,牙结石,牙菌斑,牙龈出血,牙本质敏感,牙齿不洁白,口气。”据2008年在北京、广州、上海、南京、天津、深圳等地对千名职场人士进行的一项调查显示:9成被访者不同程度地被这七大口腔问题困扰。世界卫生组织指出牙齿健康是指牙齿、牙周组织、口腔相邻部分及颌面部均无组织结构与功能异常。表现为:牙齿清洁,无龋齿,无疼痛感,牙龈颜色正常,无出血现象。口腔健康的重点在于控制菌斑,消除污垢和食物残渣,增强生理刺激,使口腔和牙颌系统有一个清洁健康的良好环境,从而发挥其生理功能,维护口腔健康。
随着人们生活水平的不断提高,工作应酬与亲朋好友聚会越来越多,牙病问题也随之增加,困扰着人们的日常生活,口腔健康越来越受到人们的重视。长时间不注重口腔清洁的人,口腔内所残留的食物易滋生口腔内细菌的生长,残留的食物易发酵为有害的牙斑酸,导致龋齿的产生。患有龋齿、牙龈炎、牙周炎以及蛀牙、牙周病等口腔疾病的人,其口腔内更容易滋生细菌,特别是厌氧菌,厌氧菌分解产生的硫化物,产生腐败的气味,形成口臭。市场上现有的口腔用品参差不齐,在目前市场上有的口香糖,牙膏,牙粉等产品中虽然也有抑制口腔病菌的作用,但效果不是很明显,而且没有止血、镇痛作用。因此,研发具有抗菌消炎作用的口腔产品迫在眉睫。
2012年5月平卧菊三七被国家卫生部指定为新资源食品。平卧菊三七,菊科植物,菊三七属,攀援草本,有臭气,茎匍匐,淡褐色或紫色,有条棱,无毛或幼时有柔毛,有分枝;叶具柄。可药用也可食用。《中国中草药汇编》下册记载:其味甘淡, 性平, 温, 通经活络, 活血生肌, 具有清热解毒、提高人体免疫力和抗病毒能力, 可以补钙、泻火、凉血、消炎、消渴生津等功效。平卧菊三七具有良好的止血、镇痛、抗炎、抗疟、抗肿瘤、降血糖等药理作用,主要用于治疗跌打损伤、风湿关节痛和痛风。
马齿苋为石竹目、马齿苋科一年生草本植物,全株无毛。全草供药用,有清热利湿、解毒消肿、消炎、止渴、利尿的作用;种子可明目;全株入药具有解毒、抑菌消炎、利尿止痢、润肠消滞、去虫、明目和抑制子宫出血等药效;外用可以治丹毒、毒蛇咬伤等症。现代药理研究表明:马齿苋对大肠杆菌、伤寒杆菌、痢疾杆菌等均有抑制作用,尤其对痢疾杆菌的作用很强。具备广谱的抗菌作用, 在中医的临床医学实践过程中应用广泛。研究发现, 马齿苋的水煎剂型对志贺氏、宋内氏、斯氏及费痢疾杆菌均能发挥显著的抑制与杀灭作用。同时马齿苋对绝大多数常见类型的食品污染性微生物, 形如大肠杆菌、沙门氏菌、志贺氏菌、金黄色葡萄球菌、变形杆菌及枯草芽孢杆菌等均具有明显的抑制作用, 即使将其实际浓度进行稀释达到12.50%水平, 也能够发挥显著的抑制细菌类微生物生长效用。研究表明马齿苋对部分真菌类微生物, 形如总状毛霉、黄曲霉及赤霉等也具备显著的抑制和控制作用。
发明内容
本发明现提供以下技术方案:本发明提供了一种中药组合物,由平卧菊三七的提取物和马齿苋的提取物制成。
本发明组合物以传统中药理论为指导原则,并结合现代药理研究组方而成。平卧菊三七具有良好的止血、镇痛、抗炎、抗疟、抗肿瘤、降血糖等药理作用。马齿苋全株入药具有解毒、抑菌消炎、利尿止痢、润肠消滞、去虫、明目和抑制子宫出血等药效;外用可以治丹毒、毒蛇咬伤等症。平卧菊三七与马齿苋均属于药食同源类药物,因此可以放心使用。本发明制备的组合物采用平卧菊三七止血的作用结合马齿苋广谱且较强的抗菌作用,达到抑制口腔细菌的生长繁殖,进而改善口腔溃疡、牙龈炎、牙周炎、口角炎、口臭等牙齿及口腔问题。该组合物制备简单,无毒副作用,不会产生耐药性,可在日常生活中长期使用。
本发明提供了该中药组合物在制备具有抗菌与止血功效的口腔用品中的应用。
本发明还提供了该中药组合物的制备方法,包括:将本发明提供的中药原药材进行提取得到中药组合物,加入药学或食品学上可接受的辅料,制剂成型,得到口腔用品。制备方法包括以下步骤:
取平卧菊三七与马齿苋原药材,加入10-12倍的水,密封浸泡30 min,加热至煮沸,保持微沸一个小时左右,分离提取液,药渣依法煎出数次(一般为2-3次),合并各次煎出液、浓缩,得到平卧菊三七与马齿苋的提取物。在此基础上加入药学或食品学上可接受的辅料,如甜味剂,表面活性剂,稳定剂等,制备所需的剂型。
作为优选,口腔用品的剂型为口香糖、牙膏、漱口水、片剂、冲洗剂。
本发明提供了一种中药组合物及其制备方法。该中药组合物由平卧菊三七、马齿苋制成。本发明具有如下优势:
1、本发明将平卧菊三七和马齿苋作为中药组合物或口腔用品的主要功能成分,能有效地起到抗菌、止血的作用,减少口腔内的病菌,降低牙病的发病率,效果好于各中药单剂;
2、本发明中药组合物只需将平卧菊三七与马齿苋的原药材在溶剂作用下,进行提取,浓缩,即可获得中药组合物;再加入辅料成型即可得到口腔用品;整个制作过程的条件简单,操作容易,且原药材易得。
具体实施方式
本发明提供的是一种中药组合物及其制备方法。
结合实施例,进一步阐述本发明:
作为优选,以重量份计,包括:
在本发明提供的实施例1中,以重量份计,包括:
取平卧菊三七原药材8份、马齿苋原药材2份进行混合,加入10-12倍的水,浸泡30 min,加热至煮沸,保持微沸一个小时左右,分离提取液,药渣依法煎出数次(一般为2-3次),合并各次煎出液、浓缩,得到平卧菊三七与马齿苋的中药组合物;
在本发明提供的实施例2中,以重量份计,包括:
取平卧菊三七原药材5份、马齿苋原药材5份进行混合,加入10-12倍的水,浸泡30 min,加热至煮沸,保持微沸一个小时左右,分离提取液,药渣依法煎出数次(一般为2-3次),合并各次煎出液、浓缩,得到平卧菊三七与马齿苋的中药组合物;
在本发明提供的实施例3中,以重量份计,包括:
取平卧菊三七原药材2份、马齿苋原药材8份进行混合,加入10-12倍的水,浸泡30 min,加热至煮沸,保持微沸一个小时左右,分离提取液,药渣依法煎出数次(一般为2-3次),合并各次煎出液、浓缩,得到平卧菊三七与马齿苋的中药组合物;
对比例1的制备
取平卧菊三七原药材10份,加入10-12倍的水,浸泡30 min,加热至煮沸,保持微沸一个小时左右,分离提取液,药渣依法煎出数次(一般为2-3次),合并各次煎出液、浓缩。
对比例2的制备
取马齿苋提取物10份,加入10-12倍的水,浸泡30 min,加热至煮沸,保持微沸一个小时左右,分离提取液,药渣依法煎出数次(一般为2-3次),合并各次煎出液、浓缩。
试验例1本发明组合物的抗菌实验
分别取实施例1~3及对比例1、2中所制备的中药组合物浓缩液20mL。浓缩液的抑菌活性的测定采用纸片扩散分析法。选取金黄色葡萄球菌、牙龈卟啉单胞菌、中间普氏菌、变形链球菌、具核梭杆菌、伴放线放线杆菌和乳酸杆菌用作指示细菌并接种在平板上,每个菌悬液吸取50μL。无菌滤纸片(直径6 mm)于浓缩液(5 mL)中浸湿,取出,置于平板上。取生理盐水为阴性对照,培养箱培养后,对抑菌区进行观察测定。
结果见表。
表1本发明中药组合物抑菌结果(n=3,`X±s,mm)
组别 | 实施例1 | 实施例2 | 实施例3 | 对比例1 | 对比例2 | 生理盐水组 |
金黄色葡萄球菌 | 15.43±0.34 | 18.09±0.27 | 19.81±0.48 | 10.10±0.42 | 22.12±0.18 | 6.10±0.35 |
牙龈卟啉单胞菌 | 15.12±0.45 | 17.25±0.36 | 19.06±0.29 | 11.31±0.37 | 21.67±0.68 | 5.39±0.54 |
中间普氏菌 | 15.26±0.44 | 17.46±0.43 | 19.95±0.43 | 11.59±0.41 | 22.35±0.43 | 5.46±0.29 |
变形链球菌 | 15.04±0.77 | 18.89±0.43 | 20.75±0.60 | 12.69±0.71 | 21.53±0.44 | 5.62±0.47 |
具核梭杆菌 | 14.54±0.64 | 17.64±0.44 | 19.66±0.44 | 10.89±0.56 | 20.37±0.88 | 6.10±0.42 |
伴放线放线杆菌 | 13.31±0.39 | 17.86±0.54 | 19.79±0.67 | 10.97±0.50 | 23.03±0.26 | 5.97±1.05 |
乳酸杆菌 | 13.35±0.27 | 16.60±0.49 | 19.59±0.77 | 10.88±0.56 | 22.76±0.53 | 6.09±0.70 |
注:表中抑菌圈直径取 3次试验的平均值。
由上述试验结果表明,本发明制备的中药组合物对上述细菌表现出显著的抑制作用。抑菌圈直径大于7mm,判断有抗菌作用,抑菌圈直径小于或等于7mm,则没有抑菌作用,由表1可知,实施例与对比例均存在不同程度的抗菌作用,且对比例2,实施例3,实施例2抑菌效果显著,表明马齿苋对口腔的致病菌具有良好的抑制作用,具有极显著差异( P < 0. 01) 。
试验例2本发明组合物的止血实验
取实验SPF小鼠常规饲养3天,然后选取健康小鼠,随机分为6组,每10只一组,标记分别标记为实施例1组、实施例2组、实施例3组、对比例1组、对比例2组、生理盐水对照组。各组间小鼠体重均无显著性差异,饲养于24~28℃,相对湿度50~65%的清洁环境中,自由摄食和饮水,使用标准饲料。采用剪尾法,实验前禁食给水 6 h后,按照灌胃剂量为每只小鼠 0.2m L/次,连续 6 天。末次给药后 45 min,将小鼠固定于固鼠皿中,用手术剪将小鼠距尾尖1cm 处剪断,待血液自行溢出开始计时,每隔 20 s 用滤纸吸去血滴 1 次,直至出血自然停止( 滤纸吸时无血为止) ,即为出血时间。以人工创面形成到出血停止所经时间作为出血时间。结果见表
表2本发明组合物对剪尾法所致的小鼠出血时间的影响(n = 10, `x ± s)
组别 | 数量(n) | 出血时间(min) |
实施例1 | 10 | 3.64±0.37 |
实施例2 | 10 | 4.16±0.56 |
实施例3 | 10 | 4.47±0.66 |
对比例1 | 10 | 3.04±0.47 |
对比例2 | 10 | 5.45±0.32 |
生理盐水对照组 | 10 | 6.33±0.27 |
止血实验结果实验结果如表所示,实施例1与对比例1均表现出了明显的止血作用,得出平卧菊三七具有明显的止血效果。
试验例3本发明组合物的凝血实验
玻片法进行实验。实验前禁食给水 6 h后,按照灌胃剂量为每只小鼠 0. 2 mL/次,连续 6 天。末次给药后 1 h,将小鼠固定于在固鼠皿中,在小鼠尾部采血,滴于载玻片,血滴直径约 5 mm,立即用秒表计时,每隔 30 s 用清洁的 7号注射针头自血滴边缘向里轻轻挑动 1 次,并观察有无血丝挑起。从采血开始至挑起血丝为止,所需时间即为凝血时间,并进行记录。
表 3 本发明组合物对玻片法所致小鼠凝血时间的影响(n = 10, `x ± s)
组别 | 数量(n) | 凝血时间(min) |
实施例1 | 10 | 0.85±0.08 |
实施例2 | 10 | 1.66±0.10 |
实施例3 | 10 | 2.46±0.10 |
对比例1 | 10 | 0.71±0.09 |
对比例2 | 10 | 2.48±0.05 |
生理盐水组 | 10 | 2.54±0.07 |
凝血实验结果 由实验结果可以得出,实施例1与对比例1均具有明显的凝血效用,实施例2的止血作用稍低,因此得出平卧菊三七具有明显的凝血作用。与生理盐水组相比,具有极显著差异( P < 0. 01) 。
试验例4本发明组合物的镇痛,抗炎实验
对两组患者口腔溃疡创面的疼痛感持续发作时间、红肿消退时间、溃疡消失时间进行观察
观察组对患者口腔溃疡处用 0.9 % 氯化钠注射液冲洗,即口腔常规清洁,在此基础上,分别取实施例2所制备的中药组合物浓缩液局部涂抹于患者口腔溃疡面,每日 3次,连续应用 7 d。对照组对患者口腔溃疡处 0.9 % 氯化钠注射液冲洗,即口腔常规清洁,在此基础上,碘甘油局部涂抹于患者口腔溃疡面,每日 3次,连续应用7 d。
表4两组患者的临床观察指标比较(n =10,`x ± s,min)
组别 | 疼痛消失时间 | 红肿消退时间 | 溃疡愈合时间 |
对照组 | 4.22 ± 0.15 | 2.58 ± 0.10 | 4.27 ± 0.08 |
观察组 | 3.17 ± 0.06 | 1.65 ± 0.10 | 3.23 ± 0.12 |
两组患者的临床观察指标比较
观察组疼痛消失时间、溃疡愈合时间均较对照组明显短,差异具有统计学意义(P <0.01),观察组红肿消退时间较对照组明显短,差异具有统计学意义(P < 0.05),见表 4。
表 5 两组患者的临床治疗效果比较
组别 | 显效 | 好转 | 轻效 | 无效 |
对照组 | 2 | 4 | 20 | 10 |
观察组 | 13 | 12 | 10 | 1 |
观察组显效与好转人数明显高于对照组,对照组轻效且无效的人数居多与对照组比较,P < 0.01,因此存在极显著差异,见表5。
本发明中药组合物优选剂型的制备工艺
漱口水或冲洗剂的制备
取实施例2制得的中药组合物30%,稳定剂0.1%,甜味剂5%,表面活性剂0.5%,剩余量为水。进行灌装,高压灭菌制备漱口水或冲洗剂。
口香糖的制备
按照以下重量比例称取原料:实施例2制得的中药组合物35%,甜味剂40%,胶基25%。按一般的口香糖的制备工艺进行制作。
牙膏的制备
取实施例2制得的中药组合物1%,摩擦剂45%、湿润剂25%、表面活性剂0.4%、甜味剂3%、起泡剂2%、香料、水余量。将中药组合物和表面活性剂山梨坦酯分散于润湿剂中,将甜味剂溶于水中,两者混合均匀。加入碳酸钙,混合研磨,捏合,真空脱气,灌装即可。
片剂的制备
将实施例2制得的中药组合物进行干燥处理;加入淀粉5%,甜味剂4%混匀,制成片剂。
Claims (6)
1.一种具有抗菌止血作用的中药组合物,其特征在于,由平卧菊三七、马齿苋制成。
2.根据权利1所述的一种抗菌止血作用的中药组合物,其特征在于,由重量份计:平卧菊三七2-8份,马齿苋2-8份,其他辅料另加。
3.根据权利1所述的一种抗菌止血作用的中药组合物,其特征在于,由重量份计:平卧菊三七5份,马齿苋5份,其他辅料另加。
4. 根据权利要求1或2所述中药组合物的制备方法,其特征在于,包括:取平卧菊三七与马齿苋原药材,加入10-12倍的水,浸泡30 min,加热至煮沸,保持微沸一个小时左右,分离提取液,药渣依法煎出数次(一般为2-3次),合并各次煎出液、浓缩,得到平卧菊三七与马齿苋的提取物,在此基础上加入药学或食品学上可接受的辅料,如甜味剂,表面活性剂,稳定剂等,制备所需的剂型。
5.根据权利要求1或2所述中药组合物在制备具有抗菌、止血功效的口腔用品中的应用,其特征在于,包括权利要求1或2所述中药组合物,以及药学或食品学上可接受的辅料。
6.根据权利要求5所述的口腔用品,其特征在于,所述口腔用品的剂型为漱口水、口香糖、牙膏、片剂、冲洗剂。
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