CN113546137B - 一种治疗或预防口腔疾病的药物组合物 - Google Patents
一种治疗或预防口腔疾病的药物组合物 Download PDFInfo
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- CN113546137B CN113546137B CN202110406671.8A CN202110406671A CN113546137B CN 113546137 B CN113546137 B CN 113546137B CN 202110406671 A CN202110406671 A CN 202110406671A CN 113546137 B CN113546137 B CN 113546137B
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- leaf extract
- sodium
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Abstract
本发明提供了提供一种药物组合物及其应用、以及含有该药物组合物的口腔护理产品、保健品、药品及植物饮料以预防、改善、或治疗治疗牙周炎、口腔溃疡、牙龈炎症、口腔异味等口腔疾病。该药物组合物含有淡竹叶提取物、桑叶提取物、荷叶提取物和黄芩提取物。该药物组合物对口腔相关疾病,诸如牙周炎、口腔溃疡、牙龈炎症和口腔异味,具有预防、改善和治疗的作用,可制备用于治疗、预防或改善牙龈炎症、牙龈出血、牙周炎或口腔溃疡等口腔疾病的药物、保健品、口腔护理产品及植物饮料。
Description
技术领域
本发明涉及日化产品、保健品、药品领域,具体涉及一种治疗或预防口腔疾病药物组合物及其应用。
背景技术
口腔健康是全身健康的重要组成部分,直接或间接全身健康。人类常见口腔疾病有龋病、牙周病、口腔黏膜疾病等。世界大量研究显示,牙周病的致病菌与冠心病的发病很强的相关性,糖尿病与牙周病发病存在共同的危险因素,切互为高危因素。口腔疾病患者口腔内的病菌源源不断地被输送至消化道,可能引发胃肠疾病,口腔病菌分泌物被肺计入可能引起吸入性肺炎。
目前认为,龋病、牙周病、口腔黏膜疾病等口腔疾病的病因都是口腔正常菌群在口腔生态失调情况下所致的内源性感染的疾病,即始动因子为菌斑微生物,而且是由特异性病原菌所致。粘放线菌(Acyinomyces viscosus,Av)、牙龈卟啉单胞菌(Porphyromonasgingivalis,Pg)、伴放线放线杆(Actinobacillus actinomycetemcomitans,Aa)等是形成口腔疾病的重要致病菌,所产生的毒素及其他有害物质可引起宿主的炎症反应,使血管渗透性增高、炎症扩散,破坏牙龈、牙骨质和牙槽骨,引起牙龈炎、牙周炎、口腔溃疡、口腔异味等口腔疾病。因此抑制口腔致病菌是预防或治疗口腔疾病的重要手段,而普遍采用龈下刮治和根面平整术进行治疗。但有研究指出,通过这种器械治疗的方法不能完全去除龈下菌斑,尤其是在深部牙周组织破坏的位点,而且这种治疗往往是治标不治本。而临床所常用的甲硝唑、替硝唑、螺旋霉素、四环素及氯已定等药物,虽有一定的疗效,但长期应用可破坏口腔的生态平衡,并且易使细菌产生耐药性,导致更加严重的后果。因此,在中药或天然物质中寻找新的预防或控制牙周病牙菌斑微生物的药越来越受到重视。
目前已有大量文献报告使用黄芩、淫羊藿、骨碎补、金银花、鱼腥草、五倍子等抗菌中药用于预防或抑制牙菌斑微生物。但目前所公开的众多预防或治疗口腔疾病中药组合物中的药材往往多达十种或数十种,例如:专利申请CN1555878A以薄荷、桑叶、葛根、柴胡、石膏、天花粉、淡竹叶、荷叶、黄连等9味药材制成的含漱液,专利申请CN101524484A以虎杖、金银花、地榆、紫草、白花蛇舌草、冬虫夏草、麝香、白果、竹叶、黑芝麻、纯枣花峰蜜、薄荷、紫苏叶、桑叶、桑白皮、透骨草、菊花、桑葚子等19味药材制成的涂膏,CN105343609A以紫苏、川木香、桑叶、玉竹、田七、青蒿、白茅根、旱莲草、川贝母、陈皮、淡竹叶、金银花、连翘、青果、苦参、白头翁、金荞麦、黑茶、薄荷、绿茶提取物、维生素B2 1-3等21味药材制成的含片,专利申请CN105687906A以白芷、薄荷、蚕蜕、倒扎龙、桂花、牙痈草、黄根、金莲花、桑叶、樟牙菜、蔓荆子、杜衡、竹叶参、薏苡仁、水团化、紫珠等16味药材制成的片剂,专利申请CN108450624A以岗梅、蜂蜜、五指柑、山芝麻、布渣叶、金钱草、金莎藤、蒲公英、荷叶、桑叶、菊花、甘草、金银花、黄芩、夏枯草、川芎、淡竹叶等17味药材制成的去火化淤凉茶等均为中药大处方,一则疗效不确切,二则所使用的药材味数繁多,制备工艺复杂,其质量难以得到保证产业化难度大,三则长期服用是否会存在不良反应并未得到验证,尤其在长期使用口腔护理、植物饮料、保健品等大健康产品领域进行商业化开发的难度更大。
鉴于此,特提出本发明。
发明内容
基于上述现有技术存在的缺陷,本发明提供一种药物组合物及其应用、以及口腔护理产品、保健品、饮料及药品,以预防、改善或治疗口腔疾病,诸如牙龈炎症、牙周炎、口腔溃疡和口腔异味等口腔症状。
为了实现本发明的上述目的,特采用以下技术方案:
第一方面,本发明提供一种药物组合物,所述药物组合物含有10-50%淡竹叶提取物、5-40%桑叶提取物、5-40%荷叶提取物0-30%黄芩提取物。
进一步所述药物组合物含有15-30%淡竹叶提取物、10-25%桑叶提取物、10-25%荷叶提取物和10-30%黄芩提取物。
进一步所述药物组合物含有10-50%淡竹叶提取物、5-40%桑叶提取物和5-40%荷叶提取物。
更进一步所述药物组合物含有34%淡竹叶提取物、33%桑叶提取物和33%荷叶提取物。
更进一步所述药物组合物含有20-30%淡竹叶提取物、20-25%桑叶提取物、20-25%荷叶提取物和20-30%黄芩提取物。
另一方面,本发明提供一种药物组合物,所述药物组合物含有5-35%淡竹叶提取物、10-60%桑叶提取物、5-40%荷叶提取物和0-50%黄芩提取物。
进一步所述药物组合物含有10-24%淡竹叶提取物、20-40%桑叶提取物、24-40%荷叶提取物和20-30%黄芩提取物。
进一步所述药物组合物含有10-35%淡竹叶提取物、10-60%桑叶提取物和5-40%荷叶提取物。
更进一步所述药物组合物含有34%淡竹叶提取物、33%桑叶提取物和33%荷叶提取物。
更进一步所述药物组合物含有24%淡竹叶提取物、24%桑叶提取物、24%荷叶提取物和28%黄芩提取物。
可选的,上述药物组合物还含有薄荷脑、冰片或二者的组合物。
本发明所述黄芩提取物可以通过2015年版中国药典所记载提取工艺进行制备或通过市售获得,主要成分为黄芩苷。
第二方面,本发明提供了淡竹叶提取物、桑叶提取物和荷叶提取物的制备工艺:
本发明通过大量研究发现按照以下水提醇沉淀工艺所提取的淡竹叶提取物、桑叶提取物和荷叶提取物的口感、收粉率均明显好于煎煮法、浸渍法等传统提取工艺。
所述淡竹叶提取物、桑叶提取物或荷叶提取物的制备工艺为:取所述淡竹叶、桑叶或荷叶加水提取1-3次,每次加淡竹叶、桑叶或荷叶重量的6-15倍量水煎煮,煎液滤过,滤液合并,浓缩,,醇沉,回收乙醇,喷雾干燥,即得;
优选地,所述淡竹叶、桑叶或荷叶加水提取2次,第一次加淡竹叶、桑叶或荷叶重量12倍的水煎煮;第二次加淡竹叶、桑叶或荷叶重量12倍的水煎煮,煎液滤过,两次滤液合并,浓缩,醇沉,回收乙醇,喷雾干燥,即得。
进一步优选的提取方案为:取所述淡竹叶、桑叶或荷叶加水提取1-3次,每次加所取药材重量的6-15倍量水,每次0.5-3h,煎液滤过,滤液合并,浓缩至1.05~1.25g/ml,醇沉,回收乙醇,喷雾干燥,即得。
更进一步优选的提取方案为:采用如下提取工艺:取淡竹叶、桑叶或荷叶,加水提取2次,第一次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃;第二次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃,煎液滤过,两次滤液合并,浓缩至1.10~1.15g/ml,醇沉,回收乙醇,喷雾干燥,即得。
本发明所获得淡竹叶提取物、桑叶提取物和荷叶提取物的口感、收粉率更佳以及淡竹叶提取物的牡荆苷、桑叶提取物的总黄酮以及荷叶提取物的荷叶碱含量更高,质量更稳定,各批次更均一,且更环保,成本更低。
第三方面,本发明提供一种口腔护理产品,含有上述药物组合物及以及辅料。
进一步地,所述辅料选自摩擦剂、湿润剂、表面活性剂、增稠剂、调味剂、甜味剂、pH调节剂、稳定剂、防腐剂、增溶剂、抗氧剂、抛射剂、乳化剂中的一种或多种辅料。
优选所述摩擦剂选自碳酸钙、磷酸氢钙、焦磷酸钙、二氧化硅、氢氧化铝中的一种或多种,所述湿润剂选自甘油、山梨醇、丙二醇或聚乙二醇中的一种或多种;
优选所述增稠剂选自羧甲基纤维素、鹿角果胶、羟乙基纤维素、黄原胶、瓜尔胶、角叉胶中的一种或多种;
优选所述甜味剂选自甘油、环己胺磺酸钠、糖精钠、三氯蔗糖、甜菊糖、甘草、甘草酸二钠、甘草酸三钾、三钠、糖精、天冬甜素中的一种或多种,所述芳香剂选自薄荷香精、薄荷油、桔皮油、香蕉香精或菠萝香精中的一种或多种;
优选所述表面活性剂选自月桂醇硫酸酯钠、月桂酰肌氨酸钠、椰油酰甘氨酸钠、α-(2-羟基乙胺)-β-苯甲酰丙酸乙酯盐酸盐、低级脂肪酸单甘油酯、十二烷基硫酸钠中的一种或多种;优选所述防腐剂选自山梨酸钾盐、苯甲酸钠、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯酸丙酯、对羟基苯酸丁酯、对羟基苯酸异丁酯中的一种或多种;
优选所述清凉剂选自薄荷酰胺、薄荷脑、薄荷酯、薄荷缩酮、薄荷酮甘油缩酮、乳酸薄荷酯、甲基二异丙基丙酰胺或薄荷烷甲酰乙胺一种或多种;
优选所述氟化物选自氟化钠、单氟磷酸钠、氟化亚锡、氟化铵中的一种或多种。
进一步所述口腔护理用品包括牙膏、漱口剂(水)、喷雾剂、气雾剂或牙粉。
进一步所述牙膏包括碳酸钙型牙膏、磷酸氢钙型牙膏、碳酸钙与二氧化硅复配型牙膏、磷酸氢钙和二氧化硅复配型牙膏、二氧化硅型牙膏、透明牙膏、羟基磷灰石为磨料的牙膏以及液体牙膏。
进一步所述牙膏含有0.1-3%上述药物组合物,余量为辅料和水。所述辅料含有摩擦剂、湿润剂、增稠剂、甜味剂、芳香剂、表面活性剂、氟化物、防腐剂、清凉剂中的一种或多种辅料。所述摩擦剂选自碳酸钙、磷酸氢钙、焦磷酸钙、二氧化硅、氢氧化铝中的一种或多种,所述湿润剂选自甘油、山梨醇、丙二醇或聚乙二醇中的一种或多种,所述增稠剂选自羧甲基纤维素、鹿角果胶、羟乙基纤维素、黄原胶、瓜尔胶、角叉胶中的一种或多种,所述甜味剂选自甘油、环己胺磺酸钠、糖精钠、三氯蔗糖、甜菊糖、甘草、甘草酸二钠、甘草酸三钾、三钠、糖精、天冬甜素中的一种或多种,所述芳香剂选自薄荷香精、薄荷油、桔皮油、香蕉香精或菠萝香精中的一种或多种;所述表面活性剂选自月桂醇硫酸酯钠、月桂酰肌氨酸钠、椰油酰甘氨酸钠、α-(2-羟基乙胺)-β-苯甲酰丙酸乙酯盐酸盐、低级脂肪酸单甘油酯、十二烷基硫酸钠中的一种或多种,所述防腐剂选自山梨酸钾盐、苯甲酸钠、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯酸丙酯、对羟基苯酸丁酯、对羟基苯酸异丁酯中的一种或多种,所述清凉剂选自薄荷酰胺、薄荷脑、薄荷酯、薄荷缩酮、薄荷酮甘油缩酮、乳酸薄荷酯、甲基二异丙基丙酰胺或薄荷烷甲酰乙胺一种或多种,所述氟化物选自氟化钠、单氟磷酸钠、氟化亚锡、氟化铵中的一种或多种。
更进一步所述牙膏含有0.3%-1%上述药物组合物,山梨醇40-60%,甘油5-10%,水合二氧化硅8-25%,十二烷基硫酸钠0.1-2%,薄荷香精0.1-1.5%,黄原胶0.1-1%,氟化钠0.05-0.24%,苯甲酸钠0.05-0.5%,薄荷酮甘油缩酮0.2-1%,三氯蔗糖0.14%-1%,冰片0.01-0.5%,薄荷脑0.01-0.4%,余量为纯化水。
更进一步所述牙膏含有0.5%上述药物组合物,山梨醇60%,甘油10%,水合二氧化硅16%,十二烷基硫酸钠2%,薄荷香精1.5%,黄原胶0.9%,氟化钠0.24%,苯甲酸钠0.2%,薄荷酮甘油缩酮0.2%,三氯蔗糖0.14%,冰片0.01%,薄荷脑0.01%,余量为纯化水。
所述牙膏制备工艺为:
1)取处方量的山梨醇真空吸入主锅;
2)预混:先用处方量的纯化水溶解处方量氟化钠、苯甲酸钠、黄芩提取物、三氯蔗糖、淡竹叶提取物、荷叶提取物,溶液搅拌至溶解,得预混一备用;将处方量黄原胶加入至处方量的甘油中,搅拌至分散均匀,得预混二备用;取处方量冰片、薄荷脑溶于薄荷香精,得预混三备用;
3)主锅搅拌真空吸入预混一、预混二,充分混合;
4)在粉仓中完成处方量水合硅石、十二烷基硫酸钠充分混合;
5)主锅搅拌真空吸入粉仓中粉料,充分混合,脱气;
6)主锅依次加入处方量薄荷酮甘油缩酮、预混三,搅拌脱气,即得牙膏成品。
其中,步骤1和2无先后顺序。
第四方面,本发明提供一种口腔用保健品或口腔用药品,其包括上述药物组合物,以及药学上可接受的辅料。
进一步上述口腔用保健品或口腔用药品可以为喷雾剂、贴膜剂、糊剂、软膏剂、凝胶剂、片剂或颗粒剂。
第五方面,本发明提供一种植物饮料,其包括上述药物组合物及食品所接受的辅料。
进一步所述植物饮料含有0.1-2%上述药物组合物、0.1-4%食品所接受的辅料和余量纯化水,所述辅料选自香料、稳定剂、着色剂、甜味剂、调味剂、增稠剂、防腐剂或抗氧剂中的一种或多种。
第六方面,本发明提供一种上述药物组合物的用途,即:
一种上述药物组合物在制备口腔护理产品、口腔用药品或饮料中的用途。
一种上述药物组合物在制备用于治疗或预防的口腔疾病的药物或保健品中的应用。
一种上述药物组合物在制备用于改善或预防口腔疾病的口腔护理产品中的应用。
一种上述药物组合物在在制备用于改善或预防口腔疾病的植物饮料中的应用。
所述口腔疾病包括牙龈炎症、牙龈出血、牙周炎、口腔溃疡、口腔异味等常见口腔疾病。
本发明优点在于:
本发明所提供组合物通过甄选特定药食同源药材,利用不同药用机理,结合特定比例进行组合,充分利用组分间的协同作用,使得所得组合物不但对口腔疾病致病菌放线菌和厌氧菌均具有明显抑制作用,而且能够去除口腔异味、口感良好,口腔刺激性小,长期安全性更高,患者长期顺应好。与此同时,本发明所提供组合物处方简单、配伍明确、制备工艺简单易于工业化生产。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述,但本领域技术人员将会理解,下列实施例仅用于说明本发明,而不应当限制本发明的范围。本发明所使用的黄芩提取物可通过《中国药典(2015版)》所记载的提取工艺进行提取或通过市售可获得。实施例中未注明具体条件者,按照常规条件或制造商建议的条件继续拧。所有提供试剂或仪器未注明生产厂商的,均为可通过市售获得的常规产品。以下结合实施例本发明的特征和性能作进一步的详细描述。实施例1:淡竹叶提取物、桑叶提取物、荷叶提取物、黄芩提取物的制备工艺
淡竹叶提取物的制备工艺:
取淡竹叶3kg,加水提取2次,第一次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃;第二次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃,煎液滤过,两次滤液合并,浓缩至1.10~1.15g/ml,醇沉,回收乙醇,喷雾干燥,即得。
桑叶提取物的制备工艺
取桑叶3kg,加水提取2次,第一次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃;第二次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃,煎液滤过,两次滤液合并,浓缩至1.10~1.15g/ml,醇沉,回收乙醇,喷雾干燥,即得。
荷叶提取物的制备工艺
取荷叶3kg,加水提取2次,第一次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃;第二次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃,煎液滤过,两次滤液合并,浓缩至1.10~1.15g/ml,醇沉,回收乙醇,喷雾干燥,即得。
实施例2、抑菌效果及口感评价试验
1.本发明中药组合物活性成分不同配比对牙周致病菌厌氧菌的抑菌活性
厌氧菌选择:牙龈卟啉菌(Porphyromonas.gingivalis,Pg)ATCC 33277。
供试品母板准备:本发明中药组合物活性成分,由四川济生堂药业有限公司提供,各组分重量百分比具体如下:
将测试A,B,C用无菌水配置成100mg/ml母液,将测试D用DMSO配置成400mg/ml母液,按照上述各组分重量百分比配置成100mg/ml。在96-深孔板里,使用相应供试品溶剂对供试品进行2倍的梯度稀释依次得到10×工作液。相应的溶剂作为生长对照(孔12)。
测试板准备:将测试培养基(Brucella agar+5μg/ml hemin+1μg/ml vitamin K1+5%(v/v)裂解脱纤维羊血)配制好后进行灭菌,待冷却至50-55℃左右,待用。
取0.3ml 10×母液分别加入6-孔板,随后加入2.7ml测试培养基,迅速混匀,获得10mg/ml、5mg/ml、2.5mg/ml、1.25mg/ml、0.625mg/ml、0.313mg/ml、0.156mg/ml、0.078mg/ml、0.039mg/ml、0.02mg/ml、0.01mg/ml等11个含2×梯度供试品,相应溶剂作为空白对照。将以上培养基放置室温冷凝固待用。
接种液准备:实验开始前4天,将甘油冻存菌ATCC 33277,ATCC BAA 308接种至脑心浸液琼脂平板(含5ug/ml hemin及1ug/ml vitaminK1),35±2℃厌氧培养4天。
实验开始前2天,将甘油冻存菌ATCC 10953接种至胰酪蛋白大豆琼脂平板(含5%无菌脱纤维羊血),35±2℃厌氧培养2天。
实验当天,挑取固体平板培养物至无菌生理盐水,用浊度仪调节细菌浓度至~1×108CFU/ml。
试验方法:分别取3μl接种液点板至测试板的每个孔里,最终接种量大约为~105CFU。菌液干后,将所有测试板放置于35±2℃,厌氧培养5天后,肉眼读取厌氧菌生长情况。
2.本发明中药组合物活性成分不同配比对牙周致病菌放线菌的抑菌活性
放线菌菌株选择:粘性放线菌(Acyinomyces viscosus,Av)ATCC 27044,伴放线放线杆菌(Actinobacillus actinomycetemcomitans,Aa)ATCC700685。
供试品板准备:按试验1准备供试品母板。
将10×工作液从化合物母板用排枪转移20ul到相应的96孔U底板中,待用。此为供试品子板。
菌液准备:实验开始前1天,将甘油冻存菌ATCC 700685和ATCC 27044接种至胰酪蛋白大豆琼脂平板(含5%羊血),放置培养箱(含5%CO2)好氧培养18~24h。
实验当天,挑取固体平板培养物至无菌生理盐水,调节浓度至1~2×108CFU/ml,然后用测试培养基(CAMHIIB含5%裂解马血或者TSB含10%马血清)稀释至菌液含~5.6×105CFU/ml.然后取180ul菌液加入供试品子板。最终放线菌接种量大约为~5×105CFU/ml,供试品测试浓度分别10mg/ml、5mg/ml、2.5mg/ml、1.25mg/ml、0.625mg/ml、0.313mg/ml、0.156mg/ml、0.078mg/ml、0.039mg/ml、0.02mg/ml、0.01mg/ml等11个梯度供试品,相应溶剂作为生长对照,此为测试板。
试验方法:将所有的测试板置于35±2℃,5%CO2好氧培养48h,肉眼读取放线菌生长情况。
上述两组试验的抑菌效果评价标准如下:
1)测试板孔内无厌氧菌的,为“+++”完全抑制;
2)测试板孔内有零星厌氧菌的,为“++”明显抑制;
3)测试板孔内的厌氧菌少于空白对照的,为“+”有抑制;
4)测试板孔内的厌氧菌多余或/与空白对照的相当的,为“-”无抑制作用。
本实施例试验1和2部分结果如下:
3、口感评价试验
评定人员由8人组成,男女各4人,对苦、涩、辛等三种口感有较高的分辨率和灵敏度。取试验一所述供试品各取1g,加热水30ml冲服,由上述人员用温水漱口后,品尝评价。
按口感苦、涩、辛等三种口感等级分为:
+++:极苦、极涩、极辛;
++:苦、涩、辛;
+:微苦、微涩、微辛;
-:基本无苦、涩、辛。
实施例3:
牙膏的制备:
处方:山梨醇56g、甘油10g、水合硅石16g、十二烷基硫酸钠2g、薄荷香精1.5g、黄原胶0.9g、氟化钠0.24g、苯甲酸钠0.2g、薄荷酮甘油缩酮0.2g、三氯蔗糖0.14g、黄芩提取物0.14g、桑叶提取物0.12g、荷叶提取物0.12g、淡竹叶提取物0.12g、冰片0.01g、薄荷脑0.01g、纯化水12.3g。
制作方法:
1.取处方量的山梨醇真空吸入主锅;
2.预混:先用处方量的纯化水溶解处方量氟化钠、苯甲酸钠、黄芩提取物、三氯蔗糖、淡竹叶提取物、荷叶提取物,溶液搅拌至溶解,得预混一备用;将处方量黄原胶加入至处方量的甘油中,搅拌至分散均匀,得预混二备用;取处方量冰片、薄荷脑溶于薄荷香精,得预混三备用;
3.主锅搅拌真空吸入预混一、预混二,充分混合;
4.在粉仓中完成处方量水合硅石、十二烷基硫酸钠充分混合;
5.主锅搅拌真空吸入粉仓中粉料,充分混合,脱气;
6.主锅依次加入处方量薄荷酮甘油缩酮、预混三,搅拌脱气,即得牙膏成品。
通过冷热试验、离心试验、室温放置实验以及试用口感发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感清凉、香甜,色泽透亮。对口腔致病菌具有抑制作用,能够有效预防或缓解牙周炎、口腔溃疡、牙龈炎症、口腔异味等口腔疾病症状,改善口腔环境。
实施例4:
牙膏的制备:
处方:山梨醇57g、甘油10g、水合硅石8g、十二烷基硫酸钠2g、薄荷香精0.1g、黄原胶0.9g、氟化钠0.24g、苯甲酸钠0.2g、乳酸薄荷酯1g、三氯蔗糖0.3g、桑叶提取物1g、荷叶提取物1g、淡竹叶提取物1g、冰片0.5g、薄荷脑0.4g、纯化水16.36g。
制作方法:同实施例3
通过冷热试验、离心试验、室温放置实验以及试用口感发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感清凉微辛,色泽透亮。对口腔致病菌具有抑制作用,能够有效预防或缓解牙周炎、口腔溃疡、口腔异味、牙龈炎症等口腔疾病症状,改善口腔环境。
实施例5:
牙膏的制备:
处方:山梨醇55g、甘油5g、水合硅石20g、十二烷基硫酸钠1g、糖精钠1.5g、黄原胶0.5g、山梨酸钾盐0.2g、甲基二异丙基丙酰胺0.5g、三氯蔗糖2.0g、黄芩提取物0.3g、桑叶提取物0.2g、荷叶提取物0.4g、淡竹叶提取物0.1g、冰片0.1g、薄荷脑0.2g、纯化水12.6g。
制作方法:同实施例3
通过冷热试验、离心试验、室温放置实验以及试用感受发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感微苦,色泽正常。对口腔致病菌具有抑制作用,能够有效预防或缓解牙周炎、口腔溃疡、口腔异味、牙龈炎症等口腔疾病症状,改善口腔环境。
实施例6:
牙膏的制备:
处方:山梨醇50g、甘油5g、水合硅石15g、十二烷基硫酸钠1g、天冬甜素1g、黄原胶0.5g、氟化钠0.05g、对羟基苯酸丁酯0.2g、甲基二异丙基丙酰胺0.5g、三氯蔗糖1.5g、黄芩提取物0.09g、桑叶提取物0.09g、荷叶提取物0.09g、淡竹叶提取物0.03g、冰片0.1g、薄荷脑0.2g、纯化水24.66g。
制作方法:同实施例3
通过冷热试验、离心试验、室温放置实验以及试用口感发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感微苦,色泽微深。对口腔致病菌具有抑制作用,能够有效预防或缓解牙周炎、口腔溃疡、口腔异味、牙龈炎症等口腔疾病症状,改善口腔环境。
实施例7:
牙膏的制备:
处方:山梨醇50g、甘油5g、水合硅石15g、十二烷基硫酸钠1g、甘草酸二钠1g、黄原胶0.5g、氟化钠0.05g、对羟基苯酸丙酯0.2g、薄荷酰胺0.5g、三氯蔗糖1.5g、黄芩提取物0.4g、桑叶提取物0.8g、荷叶提取物0.1g、淡竹叶提取物0.7g、冰片0.1g、薄荷脑0.2g、纯化水22.95g。
制作方法:同实施例3
通过冷热试验、离心试验、室温放置实验以及试用感受发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感微苦,色泽较深。对口腔致病菌具有抑制作用,能够有效预防或缓解牙周炎、口腔溃疡等口腔疾病症状,改善口腔环境。
实施例8:
牙膏的制备:
处方:山梨醇56g、甘油10g、水合硅石16g、十二烷基硫酸钠2g、薄荷香精1.5g、黄原胶0.9g、氟化钠0.24g、苯甲酸钠0.2g、薄荷酮甘油缩酮0.2g、三氯蔗糖0.14g、黄芩提取物0.12g、桑叶提取物0.1g、荷叶提取物0.1g、淡竹叶提取物0.1g、冰片0.01g、薄荷脑0.01g、纯化水12.3g。
制作方法:实施例3
通过冷热试验、离心试验、室温放置实验以及试用口感发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感清凉、香甜,色泽透亮。对口腔致病菌具有抑制作用,能够有效预防或缓解牙周炎、口腔溃疡、牙龈炎症、口腔异味等口腔疾病症状,改善口腔环境。
实施例9:
牙膏的制备:
处方:山梨醇60g、甘油10g、水合硅石8g、十二烷基硫酸钠2g、薄荷香精0.1g、黄原胶0.9g、氟化钠0.24g、苯甲酸钠0.2g、薄荷酮甘油缩酮1g、三氯蔗糖0.5g、桑叶提取物0.1g、荷叶提取物0.1g、淡竹叶提取物0.12g、冰片0.5g、薄荷脑0.4g、纯化水16.44g。
制作方法:同实施例3
通过冷热试验、离心试验、室温放置实验以及试用口感发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感清凉微辛,色泽透亮。对口腔致病菌具有抑制作用,能够有效预防或缓解牙周炎、口腔溃疡、口腔异味、牙龈炎症等口腔疾病症状,改善口腔环境。
实施例10:
牙膏的制备:
处方:山梨醇50g、甘油5g、水合硅石20g、十二烷基硫酸钠1g、薄荷香精1g、黄原胶0.5g、氟化钠0.05g、苯甲酸钠0.2g、薄荷酮甘油缩酮0.5g、三氯蔗糖1.5g、黄芩提取物1.2g、桑叶提取物0.15g、荷叶提取物0.15g、淡竹叶提取物1.5g、冰片0.1g、薄荷脑0.2g、纯化水12.45g。
制作方法:同实施例3
通过冷热试验、离心试验、室温放置实验以及试用口感发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感清凉微苦,色泽透亮。对口腔致病菌具有抑制作用,能够有效预防或缓解牙周炎、口腔溃疡、口腔异味、牙龈炎症等口腔疾病症状,改善口腔环境。
实施例11:
牙膏的制备:
处方:山梨醇50g、甘油5g、水合硅石15g、十二烷基硫酸钠1g、薄荷香精1g、黄原胶0.5g、氟化钠0.05g、苯甲酸钠0.2g、薄荷酮甘油缩酮0.5g、三氯蔗糖1.5g、黄芩提取物0.09g、桑叶提取物0.09g、荷叶提取物0.09g、淡竹叶提取物0.03g、冰片0.1g、薄荷脑0.2g、纯化水24.66g。
制作方法:同实施例3
通过冷热试验、离心试验、室温放置实验以及试用口感发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感微苦,色泽微深。对口腔致病菌具有抑制作用,能够有效预防或缓解牙周炎、口腔溃疡、口腔异味、牙龈炎症等口腔疾病症状,改善口腔环境。
实施例12:
牙膏的制备:
处方:山梨醇50g、甘油5g、水合硅石15g、十二烷基硫酸钠1g、薄荷香精1g、黄原胶0.5g、氟化钠0.05g、苯甲酸钠0.2g、薄荷酮甘油缩酮0.5g、三氯蔗糖1.5g、黄芩提取物0.02g、桑叶提取物0.02g、荷叶提取物0.02g、淡竹叶提取物0.04g、冰片0.1g、薄荷脑0.2g、纯化水24.86g。
制作方法:同实施例3
通过冷热试验、离心试验、室温放置实验以及试用口感发现,本实施例所制备的牙膏,膏体均匀,稠度适中,稳定性好,口感清凉、香甜,色泽透亮。能够有效预防或缓解牙周炎、口腔溃疡、口腔异味、牙龈炎症等口腔疾病症状,改善口腔环境。
实施例13:
含片的制备:
处方:黄芩提取物8.4g、桑叶提取物7.2g、荷叶提取物7.2g、淡竹叶提取物7.2g、乳糖50g、木糖醇18g、香精1g、硬脂酸镁1g,制法如下:将处方量的黄芩提取物、桑叶提取物、荷叶提取物、淡竹叶提取物置湿法混合制粒机中,加入乳糖、糊精、木糖醇混合均匀,用70-80%乙醇制成适宜软材,制粒颗粒,再加入处方量的香精和硬脂酸镁进行混合,压片,干燥,即得含片。
实施例14:
含片的制备:
处方:黄芩提取物2.6g、桑叶提取物2.6g、荷叶提取物2.6g、淡竹叶提取物3.2g、乳糖50g、糊精100g、木糖醇50g、香精1g、硬脂酸镁1g。
制法如实施例13
本实施例13-14所制备的含片,外观完整光洁,色泽均匀,口感甘甜、清凉,崩解时限、硬度、片重差异限度、脆碎度、微生物等指标符合药典要求,对口腔致病菌具有明显抑制作用,显著改善口腔环境,能够有效预防或治疗牙周炎、口腔溃疡、牙龈炎症等口腔疾病。
实施例14:
漱口剂
处方:黄芩提取物1.5g、桑叶提取物1g、荷叶提取物2g、淡竹叶提取物0.5g、苯甲酸钠0.2g、三氯蔗糖1g、十二烷基硫酸钠2g、薄荷香精2g、黄原胶2g、柠檬酸0.5g、纯化水1000ml。制法如下:取处方量苯甲酸钠、三氯蔗糖、黄原胶、柠檬酸、黄芩提取物、桑叶提取物、荷叶提取物、淡竹叶提取物用适量纯化水溶解,添加十二烷基硫酸钠、薄荷香精,加纯化水至规定量,搅拌均匀,静置,过滤,即得。
本实施例所制备的漱口剂,溶液澄清,口腔刺激性小,稳定性好,口感清凉、微甜,对口腔致病菌具有明显抑制作用,显著改善口腔环境,能够有效预防或治疗牙周炎、口腔溃疡等口腔疾病。
实施例15:
漱口剂
处方:黄芩提取物1g、桑叶提取物1g、荷叶提取物1g、淡竹叶提取物2g、苯甲酸钠0.2g、三氯蔗糖1g、十二烷基硫酸钠2g、薄荷香精2g、黄原胶2g、柠檬酸0.5g、纯化水1000ml。制法如实施例14。
本实施例所制备的漱口剂,溶液澄清,口腔刺激性小,稳定性好,口感清凉、微甜,能改善口腔环境,能够有效预防或治疗牙周炎、口腔溃疡等口腔疾病。
实施例16:
口腔贴膜剂
配方:黄芩提取物3g、桑叶提取物2g、荷叶提取物4g、淡竹叶提取物1g、苯甲酸钠1g、聚乙烯醇80g、羧甲基纤维素钠7g、薄荷香精2g,甘油15ml,吐温8010ml、氮酮5ml。制法如下:将以上原辅料按比例称取、混合,充分搅拌至无小气泡产生,得到混合稠膏,取混合稠膏,在涂膜剂上制成,采用多层复合加厚方法,制成厚度约0.5mm的药膜带,切割,制成含药层,置于背衬材料上,用胶粘剂将含药层平行两边方式固定,在含药层另一面覆盖保护膜。
实施例17:
口腔贴膜剂
配方:黄芩提取物2g、桑叶提取物1g、荷叶提取物0.5g、淡竹叶提取物1.5g、苯甲酸钠2g、聚乙烯醇80g、羧甲基纤维素钠5g,甘油15ml,吐温8010ml、氮酮5ml。
制法如实施例16
本实施例16-17所制备的贴膜剂具有良好的成膜性、稳定性、柔韧性和水溶性,口腔刺激性小,稳定性好,口感清凉、微甜,对口腔致病菌具有明显抑制作用,显著改善口腔环境,能够有效预防或治疗牙周炎、口腔溃疡等口腔疾病。
实施例18:
植物饮料:
配方:黄芩提取物2.8g、桑叶提取物2.4g、荷叶提取物2.4g、淡竹叶提取物2.4g。制法如下:选取黄芩提取物2.8g、桑叶提取物2.4g、荷叶提取物2.4g、淡竹叶提取物2.4g,加纯净水1000毫升煎煮20分钟,煎煮后过滤,离心,每100ml分别加入0.1%黄原胶和甜菊苷0.3%,灭菌,易拉罐灌装。
实施例19:
植物饮料:
配方:桑叶提取物3.3g、荷叶提取物3.3g、淡竹叶提取物3.4g。制法如下:选取桑叶提取物3.3g、荷叶提取物3.3g、淡竹叶提取物3.4g,加纯净水1000毫升煎煮20分钟,煎煮后过滤,离心,分别加入三氯蔗糖0.8%/100ml,灭菌,灌装。
实施例20:
植物饮料:
配方:桑叶提取物6g、荷叶提取物3g、淡竹叶提取物1g。制法如下:选取桑叶提取物6g、荷叶提取物3g、淡竹叶提取物1g,加纯净水1000毫升煎煮20分钟,煎煮后过滤,离心,分别加入三氯蔗糖0.8%/100ml,灭菌,灌装。
实施例21:
植物饮料:
配方:黄芩提取物1g、桑叶提取物4g、荷叶提取物1g、淡竹叶提取物4g。制法如下:选取黄芩提取物1g、桑叶提取物4g、荷叶提取物1g、淡竹叶提取物4g,加纯净水1000毫升煎煮20分钟,煎煮后过滤,离心,加入甜菊苷0.3%/100ml,灭菌,易拉罐灌装。
实施例22:
植物饮料:
配方:黄芩提取物0.5g、桑叶提取物0.5g、荷叶提取物4g、淡竹叶提取物5g。制法如下:选取黄芩提取物1g、桑叶提取物4g、荷叶提取物1g、淡竹叶提取物4g,加纯净水1000毫升煎煮20分钟,煎煮后过滤,离心,加入三氯蔗糖0.8%/100ml,灭菌,易拉罐灌装。
实施例18-22所制得的植物饮料,色泽均匀,口感润滑,甜味适中,稳定性好,对口腔致病菌具有抑制作用,能够有效改善口腔环境,能够有效预防或缓解牙周炎、口腔溃疡、口腔异味等口腔疾病症状。
实施例23:
配方:黄芩提取物160g、桑叶提取物32g、荷叶提取物16g、淡竹叶提取物112g、滑石粉4g、玉米淀粉76g。
制备:取上述配方量提取物和辅料分别过20目筛混合均匀,采用全自动胶囊填充机充填胶囊1000粒(每粒0.4g)。
本实施例所制备的胶囊,外观整洁,水分、装量差异、崩解时间及微生物限度均符合中国药典(2020版)标准,对口腔致病菌具有明显抑制作用,具有明显的抗菌消炎作用,能有效预防或治疗牙周炎、口腔溃疡等口腔疾病。
实施例24:
配方:黄芩提取物96g、桑叶提取物96g、荷叶提取物36g、淡竹叶提取物12g、硬脂酸镁4g、微晶纤维素52g、乳糖100g、三氯蔗糖4g
制备:取上述配方量提取物及微晶纤维素、乳糖、三氯蔗糖混合均匀后粉碎过100目筛,加入硬脂酸镁混合均匀,压片,得1000片,片重0.4g。
本实施例所制备的片剂,外观光洁、色泽均匀,素片硬度、脆碎度、崩解时限、片重差异均符合中国药典(2020版)标准,对口腔致病菌具有明显抑制作用,具有明显的抗菌消炎作用,能有效预防或治疗牙周炎、口腔溃疡等口腔疾病。
实施例25:
配方:黄芩提取物20g、桑叶提取物120g、荷叶提取物20g、淡竹叶提取物40g、微晶纤维素17g、甘露醇250g、交联羧甲基纤维素钠15g、黄原胶3g、微粉硅胶15g,纯化水适量。
制备:取配方量各组份混合均匀,加入适量纯化水润湿均匀制成软材,经挤出机挤出制粒,收料,干燥,确定装量后装100袋,每袋5g.
本实施例所制备的颗粒剂,外观光洁、色泽均匀,溶化性、脆碎度、崩解时限、装量差异均符合中国药典(2020版)标准,对口腔致病菌具有明显抑制作用,具有明显的抗菌消炎作用,能有效预防或治疗牙周炎、口腔溃疡等口腔疾病。
Claims (14)
1.一种抑制口腔疾病致病菌的药物组合物,其特征在于,所述药物组合物由24%淡竹叶提取物、24%桑叶提取物、24%荷叶提取物和28%黄芩提取物制成,其中所述淡竹叶提取物、桑叶提取物或荷叶提取物的制备工艺为:取所述淡竹叶、桑叶或荷叶加水提取1-3次,每次加淡竹叶、桑叶或荷叶重量的6-15倍量水煎煮,煎液滤过,滤液合并,浓缩,醇沉,回收乙醇,喷雾干燥,即得;所述黄芩提取物通过2015年版中国药典所记载提取工艺进行制备或通过市售获得,主要成分为黄芩苷。
2.一种抑制口腔疾病致病菌的药物组合物,其特征在于,所述药物组合物由权利要求1所述的药物组合物和薄荷脑、冰片或二者的组合物制成。
3.根据权利要求1或2所述药物组合物,其特征在于,所述淡竹叶提取物、桑叶提取物或荷叶提取物的制备工艺为:取所述淡竹叶、桑叶或荷叶,加水提取2次,第一次加淡竹叶、桑叶或荷叶重量12倍的水煎煮;第二次加淡竹叶、桑叶或荷叶重量12倍的水煎煮,煎液滤过,两次滤液合并,浓缩,醇沉,回收乙醇,喷雾干燥,即得。
4.根据权利要求3所述药物组合物,其特征在于,所述淡竹叶提取物、桑叶提取物或荷叶提取物的制备工艺为:取淡竹叶、桑叶或荷叶,加水提取2次,第一次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃;第二次加所投药材重量12倍的水,煎煮1小时,煎煮温度98~102℃,煎液滤过,两次滤液合并,浓缩至1.10~1.15g/ml,醇沉,回收乙醇,喷雾干燥,即得。
5.根据权利要求1-4任意一项所述的药物组合物在制备口腔护理产品中的用途。
6.根据权利要求1-4任意一项所述的药物组合物在制备口腔用药品中的用途。
7.根据权利要求1-4任意一项所述的药物组合物在制备饮料中的用途。
8.一种口腔护理产品,其特征在于,由权利要求1-4任意一项所述的药物组合物以及辅料制成,所述口腔护理产品为牙膏、漱口剂、喷雾剂、气雾剂或牙粉。
9.根据权利要求8所述口腔护理产品,其特征在于,所述牙膏含有0.1%-3%权利要求1-4任一项所述的药物组合物,其余为辅料和水;所述辅料含有摩擦剂、湿润剂、增稠剂、甜味剂、芳香剂、表面活性剂、氟化物、防腐剂、清凉剂中的一种或多种。
10.根据权利要求9所述口腔护理产品,其特征在于,所述摩擦剂选自碳酸钙、磷酸氢钙、焦磷酸钙、二氧化硅、氢氧化铝中的一种或多种,所述湿润剂选自甘油、山梨醇、丙二醇或聚乙二醇中的一种或多种;所述增稠剂选自羧甲基纤维素、羟乙基纤维素、黄原胶、瓜尔胶、角叉胶中的一种或多种;所述甜味剂选自甘油、环己胺磺酸钠、糖精钠、三氯蔗糖、甜菊糖、甘草、甘草酸二钠、甘草酸三钾、甘草酸三钠、糖精、天冬甜素中的一种或多种,芳香剂选自薄荷香精、薄荷油、桔皮油、香蕉香精或菠萝香精中的一种或多种;所述表面活性剂选自月桂醇硫酸酯钠、月桂酰肌氨酸钠、椰油酰甘氨酸钠、α-(2-羟基乙胺)-β-苯甲酰丙酸乙酯盐酸盐、低级脂肪酸单甘油酯、十二烷基硫酸钠中的一种或多种;所述防腐剂选自山梨酸钾盐、苯甲酸钠、对羟基苯甲酸甲酯、对羟基苯甲酸乙酯、对羟基苯酸丙酯、对羟基苯酸丁酯、对羟基苯酸异丁酯中的一种或多种;所述清凉剂选自薄荷酰胺、薄荷脑、薄荷酯、薄荷缩酮、薄荷酮甘油缩酮、乳酸薄荷酯、甲基二异丙基丙酰胺或薄荷烷甲酰乙胺一种或多种;
所述氟化物选自氟化钠、单氟磷酸钠、氟化亚锡、氟化铵中的一种或多种。
11.根据权利要求1-4任意一项所述的药物组合物在制备用于抑制口腔疾病致病菌的药物中的应用。
12.根据权利要求1-4任意一项所述的药物组合物在制备用于抑制口腔疾病致病菌的口腔护理产品中的应用。
13.根据权利要求1-4任意一项所述的药物组合物在制备用于抑制口腔疾病致病菌的植物饮料中的应用。
14.根据权利要求1-4任意一项所述的药物组合物在制备用于抑制口腔疾病致病菌的保健品中的应用。
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